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NIDA

RFI Comments - Public Health

Revised February 2015

Public Health

  • Thanks you for the opportunity to comment on NIDA’s 2015 strategic plan and future directions. Through its leadership and funding NIDA has been instrumental in creating the field of prevention science.  Consequently, I was surprised not to see prevention featured more centrally in the 2015 strategic plan. I would like to see prevention play a more prominent role in the proposed 2015 NIDA strategic plan. I support the Society for Prevention Research comments on the strategic plan that are briefly summarized below and have been forwarded in another e-mailIn general, SPR suggest three broad prevention priorities be incorporated into the NIDA 2015 strategic plan: 1) Prevention-informed and related basic research to discover and specify the mechanisms of biopsychosocial risks and protective factors and their interaction across development.2) Prevention intervention research to develop and test new interventions that extend the comprehensiveness of existing efficacy research, test emerging findings about biopsychosocial risk, specify how intervention effects are realized and for whom effects apply, and understand the salutary effects of substance abuse prevention on related problems.3) Research to understand how best to “scale up” (adoption, implementation, and sustainability) effective prevention intervention with reach and fidelity to achieve population-wide reductions in substance use, abuse and addiction, with related economic and health gains to individuals, families, communities, and state and federal government. This includes development and testing of efficient and effective modes of intervention delivery, as well as understanding how to integrate these effective preventive interventions into routine service delivery systems from health care and education to child welfare and mental health services.  In addition, research to understand the role of substance use, abuse and addiction prevention as part of the Affordable Care Act and in regulatory efforts to affect substance use and other related problems is needed.  SPR also suggests that Prevention be added as one of the unifying themes.  More details on the specific strategic areas can be found from SPR’s submission. 
  • Dear colleagues,Thank you for the opportunity to comment on NIDA’s 2015 strategic plan and future directions. Through its leadership and funding NIDA has been instrumental in creating the field of prevention science.  Consequently, I was surprised that prevention was not featured more centrally in the 2015 strategic plan. I would like to see prevention play a more prominent role in the proposed 2015 NIDA strategic plan. I support the Society for Prevention Research comments on the strategic plan that are briefly summarized below and have been forwarded in another e-mail.In general, SPR suggest three broad prevention priorities be incorporated into the NIDA 2015 strategic plan: 1) Prevention-informed and related basic research to discover and specify the mechanisms of biopsychosocial risks and protective factors and their interaction across development.2) Prevention intervention research to develop and test new interventions that extend the comprehensiveness of existing efficacy research, test emerging findings about biopsychosocial risk, specify how intervention effects are realized and for whom effects apply, and understand the salutary effects of substance abuse prevention on related problems.3) Research to understand how best to “scale up” (adoption, implementation, and sustainability) effective prevention intervention with reach and fidelity to achieve population-wide reductions in substance use, abuse and addiction, with related economic and health gains to individuals, families, communities, and state and federal government. This includes development and testing of efficient and effective modes of intervention delivery, as well as understanding how to integrate these effective preventive interventions into routine service delivery systems from health care and education to child welfare and mental health services.  In addition, research to understand the role of substance use, abuse and addiction prevention as part of the Affordable Care Act and in regulatory efforts to affect substance use and other related problems is needed.  SPR also suggests that Prevention be added as one of the unifying themes.  More details on the specific strategic areas can be found from SPR’s submission. I appreciate the opportunity to comment on the strategic plan and I hope you will find this comments helpful.
  • Thank you for the opportunity to comment on NIDA’s 2015 strategic plan and future directions. Through its leadership and funding NIDA has been instrumental in creating the field of prevention science. Consequently, I was surprised not to see prevention featured more centrally in the 2015 strategic plan. I would like to see prevention play a more prominent role in the proposed 2015 NIDA strategic plan. I support the Society for Prevention Research comments on the strategic plan that are attached and briefly summarized below.In general, SPR suggest three broad prevention priorities be incorporated into the NIDA 2015 strategic plan: 1) Prevention-informed and related basic research to discover and specify the mechanisms of biopsychosocial risks and protective factors and their interaction across development.2) Prevention intervention research to develop and test new interventions that extend the comprehensiveness of existing efficacy research, test emerging findings about biopsychosocial risk, specify how intervention effects are realized and for whom effects apply, and understand the salutary effects of substance abuse prevention on related problems.3) Research to understand how best to “scale up” (adoption, implementation, and sustainability) effective prevention intervention with reach and fidelity to achieve population-wide reductions in substance use, abuse and addiction, with related economic and health gains to individuals, families, communities, and state and federal government. This includes development and testing of efficient and effective modes of intervention delivery, as well as understanding how to integrate these effective preventive interventions into routine service delivery systems from health care and education to child welfare and mental health services.  In addition, research to understand the role of substance use, abuse and addiction prevention as part of the Affordable Care Act and in regulatory efforts to affect substance use and other related problems is needed.  SPR also suggests that Prevention be added as one of the unifying themes.  More details on the specific strategic areas can be found on SPR’s submission, attached to this email and available here: http://www.preventionresearch.org/SPR%20RESPONSE%20TO%20NIH%20RFI%20NIDA%20Strategic%20Plan%2012715.pdf.
  • Thank you for the opportunity to comment on NIDA’s 2015 strategic plan and future directions. NIDA has been instrumental in creating the field of prevention science.  I was shocked that prevention does not featured more centrally in the 2015 strategic plan. I would like to see prevention play a more prominent role in the proposed 2015 NIDA strategic plan. Because drug abuse is preventable, and the prevention of drug abuse so cost effective, the failure to include (even emphasize) prevention in the NIDA strategic plan is a serious oversight.   I urge NIDA to incorporate the Society for Prevention Research recommendations in their next revision of their proposed 2015 strategic plan.  In general, SPR suggest three broad prevention priorities be incorporated into the NIDA 2015 strategic plan: 1) Prevention-informed and related basic research to discover and specify the mechanisms of biopsychosocial risks and protective factors and their interaction across development.2) Prevention intervention research to develop and test new interventions that extend the comprehensiveness of existing efficacy research, test emerging findings about biopsychosocial risk, specify how intervention effects are realized and for whom effects apply, and understand the salutary effects of substance abuse prevention on related problems.3) Research to understand how best to “scale up” (adoption, implementation, and sustainability) effective prevention intervention with reach and fidelity to achieve population-wide reductions in substance use, abuse and addiction, with related economic and health gains to individuals, families, communities, and state and federal government. This includes development and testing of efficient and effective modes of intervention delivery, as well as understanding how to integrate these effective preventive interventions into routine service delivery systems from health care and education to child welfare and mental health services.  In addition, research to understand the role of substance use, abuse and addiction prevention as part of the Affordable Care Act and in regulatory efforts to affect substance use and other related problems is needed.  SPR also suggests that Prevention be added as one of the unifying themes.  More details on the specific strategic areas can be found from SPR’s submission.
  • Thank you for the opportunity to comment on NIDA’s 2015 strategic plan and future directions. Through its leadership and funding NIDA has been instrumental in creating the field of prevention science.  Consequently, I was surprised not to see prevention featured more centrally in the 2015 strategic plan. Because drug abuse is preventable, and the prevention of drug abuse so cost effective, the failure to include (even emphasize) prevention in the NIDA strategic plan is a serious oversight.   I would like to see prevention play a more prominent role in the proposed 2015 NIDA strategic plan. I support the Society for Prevention Research comments on the strategic plan that are briefly summarized below.In general, SPR suggests three broad prevention priorities be incorporated into the NIDA 2015 strategic plan: 1) Prevention-informed and related basic research to discover and specify the mechanisms of biopsychosocial risks and protective factors and their interaction across development.2) Prevention intervention research to develop and test new interventions that extend the comprehensiveness of existing efficacy research, test emerging findings about biopsychosocial risk, specify how intervention effects are realized and for whom effects apply, and understand the salutary effects of substance abuse prevention on related problems.3) Research to understand how best to “scale up” (adoption, implementation, and sustainability) effective prevention intervention with reach and fidelity to achieve population-wide reductions in substance use, abuse and addiction, with related economic and health gains to individuals, families, communities, and state and federal government. This includes development and testing of efficient and effective modes of intervention delivery, as well as understanding how to integrate these effective preventive interventions into routine service delivery systems from health care and education to child welfare and mental health services.  In addition, research to understand the role of substance use, abuse and addiction prevention as part of the Affordable Care Act and in regulatory efforts to affect substance use and other related problems is needed.  SPR also suggests that Prevention be added as one of the unifying themes.  More details on the specific strategic areas can be found from SPR’s submission.
  • I think providing the evidence base to respond to the emerging epidemic of non-cigarette tobacco/nicotine products (i.e. hookah, but also e-cigarettes) should be a top priority. National time trends data suggest that Hookah has become the second most popular tobacco use method among college students, and it is alarmingly increasing among high/middle school students. E-cigarettes are also beginning to show the same trends among youth. These two rising trends are seen at the time when cigarette smoking is decreasing among youth, and given the research showing the gateway potential for hookah use, and perhaps e-cigarettes, they threaten to reverse decades of hard fought successes in reducing smoking in the general population and among youth specifically.Please let me know if you need me to supply you with supporting evidence of the alarming trends for hookah and e cigarette nationally and internationally.
  • The field has known for quite some time that it takes about 5 years for the average addict to achieve self-sustainable recovery - i.e., ability to maintain recovery without extraordinary intervention or structured support.   Despite this knowledge, the bulk of NIDA research has focused on understanding the mechanisms of addiction with the main thrust being in the direction of enhanced treatments. The problem persists that treatments are short-term, and recovery is long-term.  Nevertheless, we have relatively little knowledge about optimal ways to a) connect patients to post-treatment support (a.k.a. aftercare), b) develop effective and engaging post-treatment support services (AA is just not enough, and there are far too few sober-living houses relative to those in need), and c) we still have very few monitoring systems to detect eroding recovery status to intervene before complete relapse. [And this just applies to abstinence-oriented programs.]  NIDA knows this already, but has not used this knowledge as a high-profile aspect of its strategic plan.What I suggest is linking neuroscience research to recovery.  Although the field assumes that neuroplasticity is somewhat linearly related to recovery, this has never been demonstrated with actual people in recovery over an extended period (not that I did not try to encourage such a study).  The field knows that various brain functions change with recovery, yet there is no significant investment in an economic device (like an EEG cap, for example) which could quickly and economically detect a person's stage of recovery using brain scan data (no need to scan the entire brain; just the bits shown to activate relapse -- if we knew where to look).  Would it not be nice to go to the doctor 3 or 4 times a year for a brain state checkup as a relapse prevention?   Related, but aside, being a fan of Oxford houses, I am acutely aware that they do not work for all, and that there are unacceptable relapse rates.  Nobody really has an empirically-based model of the key ingredients in sober-living arrangements that lead some residents to stay sober/clean.  There has been, I recall, a little flirtation with brain health related to sober-living vs other aftercare experiences.  It may be that Molloy' structured living helps brains recover faster by exercising cognitive processes in a repeated and structured manner - like always taking the lint out of the dryer so the next user does not have to (consideration for others).  Again, this would tie neuroscience to recovery.Good luck with the new Strategic Plan.
  • I think it would be good to investigate the prescribing practices of Emergency Depts.I was shocked and dismayed when I took my 18 year old college student daughter to a hospital (near her college) in Syracuse NY for what turned out to be a very bad viral infection.  At [the hospital] she was given morphine in her IV for complaint of a headache and not told ….I asked what they had given he, thinking it was some minor analgesic, when my daughter complained of feeling like she was “burning from the inside out” and started panicking …She was also given oxycodone tabs and a Rx for it at discharge and Zofran tabs and Rx at discharge. Giving a controlled, commonly abused substance to take back to her dorm ??? and giving her morphine for a headache?? Thank goodness my daughter is not a recovering or current drug abuser…what were they thinking? (I confiscated the oxycodone and the Zofran before she went to the dorm.) Her care there was terrible, but the freely dispensed drugs were even more concerning.Ironically, at her college there were three heroin overdoses that same weekend and one student died….How many other hospitals are doing the same kind of dispensing of controlled substances?
  • I work at Alta Pointe Health Systems in Mobile, Alabama.  I have been in the substance use and abuse field for over 20 years, working with adults and adolescents.  ADDICTION is the main key, addicted to WHAT, and how many trade one addiction for another.   A young woman very close to me That I have known for 19 years had a food addiction, and finally had the stomach surgery.  I knew she drink alcohol, and never in all my years did I see her drink until she was drunk, stupid or out of control.  After her surgery she could not eat as much so she turned her food addiction to drinking alcohol, which fed her craving, just enhanced it faster and made her feel better faster.  Her drinking alcohol became a problem with in and out of rehabs and detox.  On December 6, 2014 she died alone in a hotel.  She had alcohol saturation, internal bleeding and no brain functioning.  ADDICTION.  We need more focus on this word.  I believe her family did all they knew to do to help, but did not understand addiction.  I see adults go in and out of jail in the Baldwin County Drug Court, weekend after weekend because they just drank a glass of wine, had one beer.  These are the people who are ADDICTED.   I do not know if this is information that can help but I felt the need to write this.  You may contact me if you have any questions or would like more information from me.  I am serious when it comes to addiction, especially drugs and alcohol.  I am a certified alcohol and drug counselor in Alabama.  Worked with adults in drug court and adolescents and family in therapy.  I would be happy to help out in this study.
  •  I know I shall be sending many suggestions.  I am a counselor who has about 30 years and have worked with all populations.Treatment needs to be available for all, for as long as it is needed.  More sober living houses, I am on a reservation and we have none.  Our client go back to environmentments that make it impossible to succeed.  Also I'm soooo tired of seeing people go to prison for being addicts.  We need more support services to help those who need them.
  • Substance Abuse can cause a disabling condition. Yet Social Security law and regulations blocks payments of disability benefits to a claimant if substance abuse is a material factor in the disabling condition. Is there a valid medical or scientific way to determine the relationship of a disabling condition to substance abuse? A way to calibrate and identify a “material factor”?  NIDA fulfills this mission by supporting research to prevent and treat drug abuse and addiction and mitigate the impact of their consequences, including the spread of HIV/AIDS and other infectious diseases - See more at: http://grants.nih.gov/grants/guide/notice-files/NOT-DA-15-005.html#sthash.sSHX3Jkc.dpufA draft priority: Improve our understanding of the interaction between addiction and co-occurring conditions.I run into this problem with clients who are recovering addicts with additional medical problems – frequently heart, lung, liver, neurological and mental.  Often GSW after impacts and orthopedic issues. See: 20 CFR 404. Sub.P, Section 12.09 for an outdated method of assessment of disability based on “Substance Addiction Disorders” compared to the latest AMA Guidelines to the Evaluation of a Permanent Impairment. A joint study with IOM and SSA may be appropriate
  • As a school social worker, I would like to see FAS/FASD in the prevention strategy.  We have so many students misdiagnosed with ADHD, Conduct Disorder, Bipolar, etc who in reality have been exposed to alcohol prenatally.  This seems to be a topic that is overlooked, underdiagnosed and impacting on our society immensely.  I was pleased to see the TIP for FASD and think that raising awareness is so important. We STILL have ob/gyns who tell their patients moderate alcohol use is not harmful.  According to extensive research, it appears that middle class women are not being reached and most likely to drink during pregnancy.  Please consider this topic in your strategy plan.
  • Attn:  per the request for input on the 2016-2020 NIDA Strategic plan there appears to a great resource available for the whole mind-body studies needed, that being Duke University's adoption of the studies in Integrative Health, after 5+ years now being handed to them by the Bravewell Consortium of the military, large institutions nationwide, and 50 medical schools.  Integrative medicine has some valuable resources to combine with our pharmcogenetics movement; likewise components of Transpersonal Psychology do also.Studies on the 'Family Home Medical Model' and the use of master's level Behavioral Health Clinicians appear a cutting edge way to implement Integrative Care in the medical clinic setting, and incorporates addressing mental health and substance abuse early interventions in the medical home.  Perhaps more examination of this phenomenon is worth examination as it increases the rate of recovery and prevention of relapse in substance abuse treatment, and dual diagnosis cases.  Likewise, SAMSHA's initiative in the area of 'Trauma Informed Care' is powerful, pivotal and similarly needs to brought to medical staff at all levels, and the general public as key to recovery with dignity.Good luck!  Thank you for your hard work and the high level of quality you are developing in your initiative at NIDA
  • Thank you for the opportunity to provide comments/input regarding research priorities to be included in the revitalized NIDA Strategic Plan.In concert with the mission of NIDA to support research to prevent and treat drug abuse and addiction and mitigate the impact of their consequences, one major research priority of the new Strategic Plan should be to bring the advances of science and technology into the area where it will have the most impact on those suffering from substance abuse and addictions – jails and prisons. It is estimated that 65 to 85 percent of inmates meet medical criteria for substance abuse and addiction, yet only 11 percent receive treatment for addiction while incarcerated. Addiction to alcohol and drugs are significant factors in all crimes, including 78 percent of violent crimes, 83 percent of property crimes and 77 percent of other offenses. Inmates who have addiction problems have higher recidivism rates than their non-addicted counterparts. With the advent of the Affordable Care Act and substance abuse treatment as one of the 10 Essential Benefits of health insurance programs, hopefully those with substance abuse and addiction issues will receive appropriate and effective treatment upon release back into the communities.*  Under the section on Public Health: Increase the public health impact of NIDA research and programs, it would be helpful to have as a research priority in the revitalized Strategic Plan “to promote health literacy, health insurance literacy, improved health care decision-making and better self-care management among those impacted by substance abuse and addiction.”  We have been conducting research in this area in a county jail with positive results (see attached publications).Finally, in the subsection objective “Increase strategic partnerships with the community (academia, pharma, biotech, healthcare organizations, policy makers, etc.), under the section on Public Health: Increase the public health impact of NIDA research and programs, it would be most advantageous to include jails and prisons in the list of potential community partners. *The National Center on Addiction and Substance Abuse at Columbia University. 2010. Behind Bars II: Substance Abuse and America’s Prison Population. New York, NY: Author.  Retrieved from http://files.eric.ed.gov/fulltext/ED509000.pdfBest wishes in drafting a new Strategic Plan for NIDA,
  • The incidence of substance use disorders and treatment is so great and broad that web based engagement with consumers is ready for prime time.  We need a marketing and delivery strategy within the present communication system to identify and engage with the consumers.  What good is all the knowledge if it cannot be shared or implemented?   
  • Increase funding for adolescent treatment centers,Increase funding for recovery high schools,Increase funding for evidence based community prevention strategies/implementation
  • Dear sir or madam, I would hope that your 2016 Plan would include a major reference, and  major support - both financial and in terms of publicity - to a strategy that in 2010, Dr. Elizabeth Robertson, then chief of prevention research in NIDA's Division of Epidemiology, Services and Prevention Research, was referencing when she called the Johns Hopkins study results "stunning." She says, "What we are seeing is a change in the life-course trajectories of these kids as a result of putting them on the right path early on." If GBG were to be widely adopted in schools, she added, the public health impact could be huge. NIDA Notes. “Behavior Game Played in Primary Grades Reduces Later Drug-Related Problems.” Volume 23, Number 1, April 2010. National Institute on Drug Abuse. In 2012, NIDA reported: NIDA Notes. “Good Behavior Game Wins 2012 Mentor International Best Practice Award.” November 2012. National Institute on Drug Abuse. Yet nowhere do I see NIDA or OJJDP or SAMHSA advocating for the Good Behavior Game or the refined Pax GBG. SAMHSA put out a million dollar grant for GBG in 2010 but doesn't even mention it in the School-to-prison-pipeline reports. At a public hearing in Washington DC on April 9 of the Coordinating Council on Juvenile Justice and Delinquency, the following was just one of many statements that teachers need to be trained in managing behavior: "Classroom teachers need options and an array of tools that do not automatically lead to the justice system, with guidance in classroom management containing disruptive students." James Bell  There were representatives from OJJDP and SAMHSA and numerous others but not one thought to bring up GBG. I can simply not believe that NIDA has turned its back on something that reduces substance abuse disorders by 50%. That it has shoved onto a dusty shelf somewhere something that reduces alcohol abuse disorder by a third, smoking by 70%, and reduces delinquency, violence, bullying, suicidal ideation, ADHD, conduct disorders... You have a proven strategy that increases grades, graduation rates and college admissions. Where and when are you going trumpet it to the world? Yes, it was listed in the IOM Report on Prevention; another tome collecting figurative dust on the Cyberspace shelf. Evidently it had its 15 minutes of fame and goes back to obscurity as old news. As part of the juvenile justice system, I've spent the last 15 years looking to reduce substance abuse. I finally find something that works amazingly on substance abuse and every other evil, and no one wants to listen. Substance abuse people say "we are not going to fund school trainings" and Education people say "We've got plenty of classroom management systems, we don't need another one."So please tell me that NIDA is going to do something major on this. Does anybody realize what cutting substance abuse in half would mean? Tell me one thing you are proposing that can reduce substance abuse by 50%.
  • As part of my work in pain management I have spoken with many physicians, and many have become increasingly concerned with prescribing pain medications.  They are unsure of how much pain a patient might actually experience, and struggle to balance prescribing as needed while avoiding prescribing to a potential drug seeker or to an individual that might over time become addicted to the pain medication in question.IOM’s Relieving Pain in America report outlined the issue quite clearly.  The following is a synopsis of the information provided in the IOM report referenced:Drug Seeking Behavior and Subsequent Lack of Access For Those In Need of Pain Medications  Patients receive inadequate access to pain medications due to the well-publicized abuse of opioids and the subsequent reluctance of the many in the medical community to write prescriptions for non-institutionalized patients.  American Geriatrics Society cites delays in access to prescribed opioids for nursing home patients, including those who are terminally ill, and the American Cancer Society has recognized the frequent inaccessibility of opioids necessary for treating some pain.  According to the White House action plan between 2000 and 2009, the number of opioid prescriptions dispensed by retail pharmacies grew by 48%—to 257 million (The White House, 2011).  However, based on increased regulations to limit opioid abuse, 29% of primary care physicians and 16% of pain specialists report they prescribe opioids less often than they think appropriate because of concerns about regulatory repercussions.Of course, I have a vested interest in understanding pain and utilizing this knowledge to prevent drug abuse and also ensure those in need receive appropriate prescriptions.  Our company has patented technology developed to quantify pain levels.If I may be of assistance please feel free to contact me.  Either way, I was astounded by how many people suffer from pain and the economic toll it takes on our healthcare system and quality of life for those who are affected by pain on a daily basis.  100 million suffer and it costs $600 Billion…Good luck to you in 2015.  We are proud that the NIH supports innovation and research to improve the lives of many.
  • Hello, I would like to provide input for the revision of your strategic plan. I live in Washington State, where the sale and possession of marijuana has recently been legalized. I also have teens and young adults in my family who are at the age where drug experimentation becomes an issue. I sense a trend in thought amongst them that because it is now legal, marijuana has somehow shifted into the mental category of being "safe", and frighteningly enough, not addictive. There are plenty of misconceptions about how addictive it is, and also a great deal of misunderstanding about what exactly are its true medical uses. Kids seem to be getting their information from other kids and also from the internet, where the "if it's published on the internet it must be true" mentality prevails. I would like to see more public education in states who have chosen to legalize or decriminalize marijuana, and a general emphasis on prevention through frank and scientifically based education first, and harm reduction second, but of course that should include adequate treatment opportunities. If you would like further input from me, please do not hesitate to contact me at this address.
  • A public health approach to problems would be valuable in studying nonmedical use of opioids.  It’s long overdue because a public health approach automatically widens the data fields sought.  Also, the sharing of information must be opened up, becoming more transparent.  The pendulum has swung too far toward law enforcement.  DEA, state authorities, etc., need to share so potential interventions would have a chance.  Silos have developed, whereas in the 1970s and 80s there was much more sharing among state and federal authorities and researchers.  I wish to mesh the use of opioids, medical and nonmedical, with attained education, income, and health-care quality star-ratings.  I submit that states with the larger opioid-use problems also have higher poverty, unemployment, and lower health-care star ratings.Pharmaceutical waste, also, including opioids, needs a federal approach, especially regarding funding of take-back and disposal programs.  IOM can work on the issue to come up with a program (similar to what eventually happened with track-and-trace).   PhRMA is focused on suing the Alameda County take-back funding model, which is wasteful legislation to me.  Even the paint industry is supporting-embracing a viable/realistic program that can be nationwide.  The recent DEA take-back legislation is not transparent enough and has unnecessary obstacles for the program to be successful.A patient-concern I have with the pendulum having swung toward law enforcement is that patients with a medical use for opioids have a tendency to be considered “guilty” rather than “innocent” regarding their use motives.  My suggestions; thank you for the opportunity.
  • Nice job on the draft priorities. I suggest the following:Public Health:Using health communications approaches to publicize the impacts of the legalization of marijuana would be essential.Simplified application process  for bringing evidence-based prevention to Native Americans would lead to the testing of models that could be adapted by other tribes.Thanks for asking for our input.
  • I feel more research into marijuana effects and ways to quit marijuana would be important. It is very difficult teaching children that marijuana should not be used as more and more states are legalizing the drug. I've seen the damage it does and know it is not safe.
  • Dear colleagues, Thanks for the opportunity to provide comments for NIDA new strategic plan.Here are our comments for your consideration. Given the importance of HCV as a parenteral infection, seriously impacting the morbidity and mortality of persons who inject drugs, there is a need for more focused and increased understanding of this infection as a problem and for support for examining HCV and HBV among persons who inject drugs. HCV infection needs to be a priority as the many other serious health problems that arise from addiction, including the alarming increase in drug overdoses and HCV transmissions caused by increased injection drug use. Unintentional, opioid-related overdose and HCV infections as sequelae associated with the prescription opioid epidemic ought to be a key priority area; as should the recent increase in heroin use and injection among young adults, given that non-medical injections are the driver of HCV infection incidence in both urban and non-urban settings.  Support for studying HCV treatment patterns can be expanded to investigate the efficacy of co-localizing HCV treatment in substance abuse treatment settings, including both in-patient and out-patient settings.  As HIV incidence and prevalence among the population of young persons who inject drugs are both currently at nominal levels means that HCV mono-infection among this population needs to be prioritized as a key area alongside HIV/HCV co-infection.  The diverse harms associated with drug addiction is a clear indication of the need to investigate the efficacy of integrated health services for persons who inject drugs. Given that male-to-male sex (MSM) and illicit injection drug use (IDU) are important transmission routes for human immunodeficiency virus (HIV) infection and that MSM/IDU are particularly vulnerable to infection and can transmit HIV through sexual behavior or by sharing syringes, promoting research that addresses MSM/IDU and Young MSM/IDU would be valuable. More attention is needed to address the (1) relationship between methamphetamine use and STD transmission (especially syphilis), particularly among men who have sex with men (MSM), (2) relationship between methamphetamine use, participation in group sex, and STD transmission, particularly among MSM, and (3) the effectiveness of integrating brief assessment tools/interventions for alcohol and substance abuse into STD care settings. Given the cost effectiveness of safer injection facilities in controlling infectious diseases, as indicated from research results and demonstration projects in other countries, it seems important to facilitate research and programmatic projects about this valuable intervention within a comprehensive set of interventions and policies for persons who use drugs. Assess and address methamphetamine use and it addiction and infectious diseases consequences ang heterosexual populations.
  • Overall the plan is a well thought out approach to the science behind the treatment of addiction, the need to educate and such. Seems far too general as to the stages of drug use disorders and addiction and should also speak to a greater extent to science of prevention, early intervention and long term recovery in the community. Much like diseases like diabetes, cancer and heart disease the need for supports beyond the treatment of addiction are crucial. I cannot say enough about the ability to intervene with at-risk populations early and often and not require a diagnosis per se.
  • Established in 1967 as the only statewide advocacy organization in Illinois focusing solely on substance use disorder issues, we represent more than 50 prevention, treatment and recovery organizations across the state. Our mission is to advocate for people interested in the substance use disorder field, including clinicians, consumers, family members, individuals in recovery and youth. We envision a healthy society where everyone benefits because alcohol/drug abuse occurs rarely, addicted people have access to effective treatment, more people are in recovery, everyone participates in prevention and health promotion, and our laws, public policies and cultures enhance everyone's well-being. We work hard to educate the general public about the disease of addiction, sharing the message that addiction can be prevented, it can be treated and people can recover from it.Interest in substance abuse- amongst policy makers, the public, and health care professionals are also at an all time high.  A confluence of factors, including but not limited to the legal status of marijuana, a resurgence in heroin use, and the ever increasing abuse of opioid painkillers, has led us to this moment. As advocates and activists demand more action, NIDA must be one of the leaders in this fight. Its research, and perhaps more importantly its dissemination of this research, should lead the way forward, just as research led us to the advances we have made against modern plagues such as HIV, or even diseases no longer considered commonplace, such as whooping cough, small pox, or diphtheria.  It is our belief that research at NIDA exists for one reason above all others: to improve the treatment of substance abuse and addiction.  In this vein, we wish to see a continued emphasis on the translation of research into practice. Addiction and abuse are just as costly to this country as cancer, hypertension, or diabetes, yet the research dollars appropriated to finding better substance abuse and addiction treatment pales in comparison to that of the institutes that study these other diseases. This must be remedied.  The economic impact of addiction and abuse either equals or outpaces that of almost every other disease, so the economic investment in finding cures has to keep pace.While policymakers have given substance abuse increased attention in recent years, they only do so in response to increased use in specific narcotics.  For example, for most of last decade, a large amount of legislation was introduced aimed at curbing the use and abuse of methamphetamine.  Over the first part of this decade, attention has shifted to opioids.  Congress responds to the drugs that make headlines, yet rarely- if ever- do they address the underlying disease of addiction. We believe it is the role of NIDA to emphasize- to both policymakers and the public- that no matter what advances are made in the fight against specific narcotics, the larger picture must always remain the effort to cure this one underlying disease.NIDA’s RFI asked us to address the issue of “Increased readiness to respond to emerging public health priorities (opioid overdose epidemic, potential consequences of marijuana legalization, changing healthcare landscape, emerging drug trends, etc.)” As healthcare- and substance abuse treatment- finds its way in a new world order, we will become more reliant than ever on protocols that are proven effective and efficient.  This includes research on treatment settings, treatment protocols, and a variety of other factors.  It is no longer an issue of simply how treatment is provided- also in need of consideration is the where, by whom, and when.The treatment of substance abuse and addiction is a continuum, and a complex one at that.  Often this continuum is broken down into three categories- prevention, treatment, and recovery. Yet even these categories can be divided.  Prevention strategies for youth differ from prevention strategies for other age groups- and other age groups do need prevention strategies.  Older Americans are abusing drugs at a rate never before seen, and at a rate not matched by other demographics. The over-availability of powerful prescription drugs has contributed to this, and new prevention strategies are in order.  Within treatment, we need to see more research done on the medical aspects of detoxification.  In many states, the only addiction treatment service covered by Medicaid is detoxification.  While this needs to change, at present, detox is the only bite at the treatment apple that many will get, so it must be done while guided by the most recent, proficient research.  In terms of other treatment protocols, treatment is far from one-size fits all.  There are setting considerations: inpatient, outpatient, intensive outpatient, and more. Settings can be hospitals, clinics, private treatment facilities, public treatment facilities, and on and on.  Then there are cultural and ethnic considerations to address.  Men and women approach treatment differently. Latinos, Native Americans, African Americans, and other ethnic groups have different considerations to address.  Special populations such as veterans, active duty military, and others deal with issues that can impact treatment and recovery.  We need to see NIDA fund research that takes all of these factors and variables into consideration.There are many regulatory issues that surround substance abuse treatment, which NIDA cannot fix directly, but can indeed contribute to a fix.  One example is the Institute for Mental Diseases (IMD) exclusion.  The IMD Exclusion was enacted in 1965 to prevent Medicaid funds from covering treatment in large psychiatric hospitals. Section 1905(a)(B) of the Social Security Act defines an IMD as any “hospital, nursing facility, or other institution of more than 16 beds, that is primarily engaged in providing diagnosis, treatment, or care of persons with mental diseases, including medical attention, nursing care, and related services.” When the law was enacted in 1965, substance abuse was widely regarded as a mental health disorder, and facilities that treated SUDs fell under the jurisdiction of the IMD. The medical understanding and treatment of substance abuse and mental disorders has changed considerably since 1965. However, today’s community-based residential substance use disorders (SUD) treatment providers are still subject to the restrictions of the IMD Exclusion – a single unit of 16-beds or fewer per unique address.  NIDA research on effective treatment in terms of facility or group size can be of great value in illustrating the arbitrary 16-bed limit for facilities receiving Medicaid reimbursement.  Research could also feasibly be conducted on the efficacy of not only group size, but on network size as well, and on the best ratios for practitioners to patients. Marijuana is not only a hot button topic politically, but scientifically as well.  Public policy regarding marijuana continues to be made at a high rate, and too often science does not play a large enough role in the debate.  NIDA needs to make the availability of research findings- both current and past- more visible and readily available.  In addition, because policies are moving so quickly, NIDA must investigate research that can be conducted and disseminated rapidly.  We understand that the scientific process is a deliberate one, and scientific findings should not be compromised because research was conducted hastily. Yet in a situation such as this one, rapid results are a necessity if the science is to play a role in formulating policy, as well as influencing public opinion.  A very high percentage of consumers who utilize substance abuse treatment services suffer from other health disorders as well.  NIDA must continue its work in co-occurring disorders.  The co occurrence of substance abuse and mental health disorders is well documented, and NIDA should continue to collaborate with other institutes in order to develop effective treatment protocols that will allow consumers to be treated for multiple behavioral disorders simultaneously, rather than have their treatment “siloed.” In addition to mental health issues, many of those with substance abuse disorders suffer from a plethora of other health complications.  Often, these consumers first point of contact with any form of health care is treatment for their addiction or abuse.  Yet with the right treatment protocols in place, they can also be treated for other health issues.  NIDA should explore studying how those who get treated for substance abuse may have difficulty addressing other public health problems, and how those who enter the health care system for a substance abuse disorder can benefit by becoming a healthier person on the whole.At present, NIDA does excellent work in the dissemination of its findings, but these efforts appear limited to major research grants or events, such as Monitoring the Future, or National Drug Facts Week.  Research in addiction and substance abuse treatment should be given the same attention and reverence usually reserved for breakthroughs in research pertaining to cancer or HIV.  While there has definitely been more attention paid to these advances over the last decade, more still needs to be done.  When a scientific breakthrough has the ability to improve the lives of millions of people, full advantage must be taken.  
  • My specific comments are in reference to the section of the draft priorities titled “Public health: Increase the public health impact of NIDA research and programs”. The first bulleted point focuses on the importance of understanding the factors that affect the integration of evidence-based research findings into healthcare policy and practice (implementation science). Empirically rigorous and theoretically grounded implementation science research is critical in helping to close the research to practice gap. If we really want to ensure that evidence-based practices are incorporated into routine care, then is it essential to focus effort on the frontline professionals who deliver services to patients in treatment programs and allied mental health care facilities. This includes research on recruitment, training, career development, retention, and performance management of counselors and other mental health care professionals. In addition, research on the role that clinical supervisors play in encouraging, rewarding, and increasing the uptake of evidence-based practices in treatment settings is sorely lacking, even though these individuals play a critical role in shaping the climate for implementation and use of evidence-based treatment as well as creating a psychologically healthy work environment for counseling staff. Interventions to help stabilize the drug treatment workforce are also needed as well as increase the attractiveness of this profession to individuals preparing to enter the workforce. Given the high demand for drug treatment services ensuring that we have a workforce that is prepared (qualified), motivated, and stable is essential to ensuring high quality care to patients seeking treatment.
  • National and international directives of the past two decades have declared that prevention programs aiming to reduce illicitdrug use, excessive alcohol use and the misuse/abuse of prescription drugs should engage all strata of society in dialogue andcollaboration. Although companies are affected in many ways, efforts to engage the business sector in these programs have been only marginally effective.In terms of research, this topic is highly underrepresented. The few available papers and programs from this particular field suggest that there are ways to involve companies in the fight against substance abuse (See for instance the attached poster presented last year at the NIDA session of the 2014 SPR Annual Meeting in Washington D.C.). However, more rigorous research would needed.Suggestions: - We suggest to support research programs that specifically aim to understand how to involve business sector in the fight against substance abuse.- These programs should investigate the reasons of the limited business participation.- Pilot programs that would test emerging hypothesis should also be emphasized.  - More communication and the exchange of knowledge would also be needed. In tis regard we suggest to consider funds particularly for national and/or international conferences, workshops for scholars, government representatives and other affected stakeholders.
  • Use sound experimental design and hypothesis testing to improve our understanding of the ethical implications of research in terms of impact on study subjects, participation of study subjects, communication of research results, and application of research findings to underserved populations. Although research exists on these topics, the majority is qualitative rather than quantitative. To ensure that we continue to conduct research in an ethical manor, we need to use our qualitative knowledge to develop and test hypotheses using sound experimental design
  • In pursuit of NIDA’s goal of addressing drug abuse and addiction through research, I recommend the following (several of these are in the draft strategies):Improve the translation of evidence-based preventive interventions into diverse service systems, such as primary care.Develop methodology to support research on implementing effective prevention, service, and treatment programs.Establish federal partnerships where NIDA staff or funded researchers can evaluate and provide knowledge to improve the delivery of prevention and/or treatment services for drug abuse and addiction.Increase the support of early career investigators, especially those from underrepresented minority populations.Strengthen the focus on bi-directional translational research involving communities.
  • We commend NIDA for renewing its vision for increasing our knowledge about drug addiction. The draft strategic priorities outlined in the request for information are wide-ranging and are appropriately highlighted as valuable for the field and for future research.  However, health services research is a clear omission in the draft strategic priorities.  Health services research is a tool to study drug use and addiction in the context of other substance use, health issues, biopsychosocial factors and the systems of care that serve individuals with drug problems. In a rapidly changing environment it is essential to understand drug use and addiction within this real-world context. A health services research perspective is based on the premise that addiction-related prevention and treatment services can be effective when access to services is optimal, when people use the amount and type of services that clinical research has shown they need, when the services are provided in a cost effective manner and when current clinical best practices and quality guidelines are adhered to. These concepts are key to the standard health services framework that examines effectiveness in terms of access to care, utilization of services, cost, quality and clinical and social outcomes.  A focus on substance use services research continues to be crucial because of the continued magnitude of drug problems in the US; the complexity of the prevention and treatment systems for drug problems; the emergence of new approaches to treatment; the expanding role of information technology; and the ongoing changes in the broader healthcare delivery system, including recent parity legislation and health reform. Each of these offers opportunities and challenges for individuals preparing to do research focused on drug use prevention and treatment.  Further, the substance abuse treatment system is financed by an array of funding mechanisms that complicates the provision of quality care to individuals whose needed services may cut across multiple funders and providers. As with the U.S. health care system overall, cross-cutting organizational and financial issues contribute to rising health costs and there are overriding concerns about the quality of services provided and inequities in health status and access. With the passage of federal parity legislation, the Affordable Care Act, and state health reform initiatives, and increased focus on integrated care as well as policy approaches such as prescription-monitoring programs to reduce opioid misuse, health services research takes on even greater relevance.
  • We offer the following comments for your consideration.Prevention: Evaluating Evidence-Based PracticesState Substance Abuse Agencies (SSAs) report that 75 to 80 percent of prevention fundsare spent on evidence-based practices. However, it would be helpful if SSAs had more affordable tools at their disposal to ensure that interventions are delivered as intended anddesired outcomes are achieved. SSAs need valid, reliable, and affordable methods andinstruments to document fidelity and/or outcomes. This should take into consideration varying settings and populations and include all types of interventions, including policy and environmental strategies.Prevention: Monitoring Emerging Trends and Leveraging Lessons LearnedIn addition to monitoring emerging public health priorities and drug use trends, NIDA is also in a position to support research to evaluate how policy and other environmentalchanges affect drug use trends. Timely monitoring and evaluation also increases the prevention and treatment fields’ readiness to respond to shifts in demographic and use trends. NIDA should also support research to evaluate how environmental preventionstrategies affect use trends, particularly for tobacco, marijuana, and prescription drugs. NIDA should also continue to develop resources that assist SSAs with bringing researchto practice.Office-Based Opioid Treatment (OBOT)OBOT has rapidly become a major modality of care, but questions remain about diversion, patient safety and accountability, quality of care, coordination with behavioraltherapies, and outcomes that can be addressed through research. This is particularly important given that under health reform, an increasing number of traditionally “safety net” patients are gaining health insurance that covers office-based treatment.  While datais available on how many patients are receiving buprenorphine and depot naltrexone via OBOT, numerous opportunities exist to provide more insight into the nature and quality ofthat care or outcomes.Recovery Services and SupportsRecovery-oriented systems of care (ROSC) have become a major theme in aligning services and supports to help thosewith substance use disorders. Often ROSC services operate within treatment systems, and at other times patients access ROSC without formal treatment. As this service modality continues to develop and evolve, research should be supportedthat provides more information about how many individuals utilize recovery services, what types and amounts of servicesthey use, and the results achieved. This growing body of literature can help guide States as they build their capacity for ROSC.The Role of Residential Services in the Continuum of CareSSAs spend more than 50 percent of their treatment funds on residential services, which includes long- and short-termcare and residential detoxification. There are several new research opportunities to strengthen and expand the current research base on residential services and provide additional context for new payers in both the public and private insurance spheres as they design their coverage plans. Additional research would be helpful to examine how individual components of residential care, such as lengths of stay, can be leveraged for clients based on their clinical needs and ultimately improve outcomes.We sincerely appreciate the opportunity to comment and look forward to the release of the final Strategic Plan
  • I appreciate the opportunity to comment on NIDA’s 2015 strategic plan and future directions. Through its leadership and funding NIDA has been instrumental in creating the field of prevention science.  Consequently, I was surprised not to see prevention featured more centrally in the 2015 strategic plan. I strongly recommend that NIDA revise the proposed strategic plan to include prevention in a more prominent role. As a member of the Society for Prevention Research, I support SPR’s comments on the strategic plan that are briefly summarized below and have been forwarded in another e-mailIn general, SPR suggest three broad prevention priorities be incorporated into the NIDA 2015 strategic plan: 1) Prevention-informed and related basic research to discover and specify the mechanisms of biopsychosocial risks and protective factors and their interaction across development.2) Prevention intervention research to develop and test new interventions that extend the comprehensiveness of existing efficacy research, test emerging findings about biopsychosocial risk, specify how intervention effects are realized and for whom effects apply, and understand the salutary effects of substance abuse prevention on related problems.3) Research to understand how best to “scale up” (adoption, implementation, and sustainability) effective prevention intervention with reach and fidelity to achieve population-wide reductions in substance use, abuse and addiction, with related economic and health gains to individuals, families, communities, and state and federal government. This includes development and testing of efficient and effective modes of intervention delivery, as well as understanding how to integrate these effective preventive interventions into routine service delivery systems from health care and education to child welfare and mental health services.  In addition, research to understand the role of substance use, abuse and addiction prevention as part of the Affordable Care Act and in regulatory efforts to affect substance use and other related problems is needed.  SPR also suggests that Prevention be added as one of the unifying themes. More details on the specific strategic areas can be found from SPR’s submission.
  • Transforming Youth Recovery as an organization applauds the continued efforts of the National Institute on Drug Abuse in its expansive funding to use science to change the way we understand and approach the problems of addiction and substance use disorders. Our overarching response to the 2016-2020 Strategic Plan advocates for the inclusion of recovery across all strategic priorities currently presented. While the role of prevention, intervention and treatment are paramount to understanding addiction to exclude recovery is to look at only part of the full spectrum of substance use disorders.We feel the importance of recovery is understated in the 2016 strategic plan and in the scientific investigation of addiction at large. Recovery can and should be integrated into most all of the priority areas outlined in the current strategic plan. In particular the clinical and translational sciences priority specifically states a mission to incorporate the diverse needs of individuals with substance use disorders, to minimize recovery from this mission is to ignore an essential component in the lives of those affected by addiction. We are excited to see the inclusion of biomarkers of recoveryand acceleration of neurobiological recovery as target areas in the clinical and translational priorities, however these are minimal in comparison to other efforts and do not take into account the importance of a thriving network of support and community in the path to recovery from addiction. While there is a wealth of literature investigating the types of interventions and programs that most efficiently assist individuals in the process of ceasing substance misuse and relapse prevention there are no recovery best practices. The factors and assets that support individuals in long­ term recovery and aid them in successfully reintegrating into a healthy, productive life should be well studied.We also find recovery to be an essential component in broad public health concerns. Too often the emphasis is placed upon prevention, intervention and treatment with little thought left to the long-term maintenance of sobriety and the increase in quality of life that should follow the cessation of substance misuse and, moreover, the ability to institutionally support these processes. Under the public health priority there is a listed desire to increase readiness to respond to emergmg public health priorities of which we strongly feel recovery is. The necessary increasedattention on the opioid overdose epidemic will undoubtedly save Jives and getindividuals in touch with appropriate treatment resources and services.  But what happens when this population completes treatment?  How is their community  ready to support them as they begin their journey  into long-term recovery? We propose that recovery also be considered in the goal of increasmg strategic partnerships with the community. We have witnessed the transformative power of community asset mapping to change a landscape of a community to support recovery as well the leveraging of these assets to meet specific goals and grow recovery communities. Funding andresearch opportunities to better understand and communicate how this processbenefits and grows recovery communities would be keystone in increasing theinstitutional readiness of healthcare systems, academia and public policy to supportrecovery as part of the spectrum of substance use disorders.We were pleased to see the role of development across the lifespan and the differential consideration of adolescents suffering from addiction as a unifying theme in the 2016-2020 strategic plan and again we propose the inclusion of recovery in these efforts. Adolescence is a time when much substance use begins and this unfortunately often interferes with the pursuit of higher education. As an organization we have made it our mission to better understand, fund and support recovery for students, especially college students. Collegiate recovery is an area of rapid growing interest and demand.College students seeking or maintaining sobriety need specialized support and services to thrive in an environment that is so often hostile to recovery. Other than the groundbreaking work of Alexandre Laudet this is a vastly understudied area. Further funding, research and communication of how institutions of higher learning have and can support students in recovery could enormously change the landscape of how young people with addiction move through their journey to recovery.We understand that these goals are not without challenges and obstacles. The beauty and difficulty lies in the diversity of the recovery community. Addiction does not discriminate and therefore the population of individuals in long-term recovery varies tremendously. We also acknowledge that recovery communities from area to area, school to school and between age groups also vary tremendously. However, we view these potential challenges as strengths, a diversity in sampling could allow for the strong generalization of potential findings. We feel that the ultimate benchmark of these efforts would be to see recovery, particularly collegiate recovery, accurately represented as part ofthe continuum of substance misuse prevention, intervention and treatment. We see the increased dissemination of research findings relevant torecovery in the scientific and academic communities as vital to transforming the way weapproach recovery as a society at large. We have seen the grassroots recovery efforts grow exponentially in the last few years and want to see the institutional efforts match this work so there can be a thriving bi-directional relationship between community and institution to support individuals in long-term recovery everywhere
  • Thank you for the opportunity to comment on NIDA’s 2015 Strategic Plan. I appreciate the thoughtfulness that has gone into this and the openness to further input. My main concern with the draft plan is inadequate attention to the important role of prevention. No doubt there are many realms of research making important contributions to the understanding of and reduction in drug abuse. But I would think that prevention approaches would be at least one of the pillars of NIDAs strategic plan, particularly given all the wise investments NIDA has made to help move prevention approaches from conceptual confusion to an effective science. In my view, prevention is the only approach that has the potential of steering people away from the destructiveness of drug abuse in the first place, and does so by methods that are relatively cheap, involve no physical or biochemical intrusion, and with the only side effects of building individuals’ psychosocial strengths and nurturing the overall health of families, schools, and communities. I respectfully urge you to not only give prevention a more prominent role in NIDA’s Strategic Plan, but to consider how prevention might be promoted as a “first option” and a core principle underlying the goal of drug abuse reduction.

Basic Science, Clinical and Translational Science, Public Health

  • Thank you for your invitation regarding input in the NIDA  research priority. I have read the list of 2015-2020 NIDA priorities in NOT-DA-15-005.   All listed research priorities are very critical and of great interest. I would add 3 additional topics.1. Correlation of genomic polymorphism or variations  with vulnerability to drug abuse in the population.2. Development of vaccine to prevent drug abuse  that can be used in the high-risk (genetically or socially) sub-population.3. Integration of social networking behavioral pattern and communication  and internet strategy for drug prevention education  (like targeted and personalized marketing, high-risk individuals (identified via analyzing social networking behavior and movement data  can be targeted with drug abuse prevention educational ads or text messages).
  • General Terrific (and ambitious) plan Consider including feeding behavior/overeating and the interactions with addictive behaviors, given the overlap in circuitry and compulsive features.  The continued emphasis on basic science, including genetics, epigenetics and biomarkers,  is very important. The emphasis on the integration of evidence-based research findings into healthcare policy and practice is also excellent. Additional areas that received less emphasis but which continue to be important include: -Improve understanding of the common mechanisms and trajectories underlying addictive disorders and complex health behaviors associated with addiction, including sleep problems and obesity.  For example, such research could inform whether a sequential approach to treatment is more or less efficacious than changing multiple behaviors simultaneously.-Under clinical and translational science, it appears that “focused development efforts” do not include addictions for which FDA approved treatments ARE available (e.g., nicotine dependence, opioid dependence).  While approved treatments may be available, there is substantial room for improvement in outcomes and development of new treatments. Perhaps this is not meant to imply that development efforts in these areas are not a priority; however, as written it implies that only addictions without FDA approved treatments will be a priority. - Integration and application of evidence to promote changes in local and federal regulation relevant to addiction.  We are reaching a threshold of having sufficient data, for example, on particular tobacco products and messaging, that can and should applied to inform regulatory efforts. -Determine not only the risks, but also the potential therapeutic benefits, of changes in medical marijuana access and use.  The current portfolio focuses exclusively on the risks. However to facilitate evidence-based regulation, a risk and benefit analysis would be important.-Identify efficacious methods for increasing the broad utilization of evidence based treatment in underserved populations, such as those of lower SES and those with comorbid medical or psychiatric conditions. While the current plan highlights implementation science to influence integration of findings into healthcare practice, this does not ensure that the most vulnerable individuals will avail themselves to utilize these services.
  • Thank you for the opportunity to provide comments on your draft 2016-2020 Strategic Plan. As someone who has spent the past 15 years working on hepatitis C and/or overdose prevention among injection drug users and in the criminal-justice involved population in public health settings, I applaud your efforts to achieve the following objectives:Basic NeuroscienceBetter define the interactions between addiction and pain, including molecular, genetic, behavioral , and neural-circuit-related factors, to guide the development of alternate treatment strategies for pain patientsImprove our understanding of the interaction between addiction and co-occurring conditions Elucidate the impact of mental health, HIV, HCV, pain, etc. on addiction; Accelerate medications development for SUDsClinical and translational scienceFocused development efforts on: Overdose prevention or reversalAccelerating neurobiological recoveryAddressing comorbidities (MH, HIV, HCV, pain)Identify measures other than abstinence that can reliably assess SUD treatment outcomes Identify biomarkers of addiction, resilience, and recovery to enable personalized treatmentThis last point is critical because a fixation on abstinence as the sole goal of drug treatment is serving as a major barrier to people with addiction and/or hepatitis C accessing housing, shelter, and life-saving hepatitis C treatment due to policy requiring abstinence even when this is not a desired or even necessarily realistic goal for many individuals. Part of the problem has been that “harm reduction” as a term is anathema to policymakers, yet no alternative framework seems to have been accepted into common usage. Public HealthImprove the understanding of factors that influence the integration of evidence-based research findings into healthcare policy and practice (implementation science)Increase readiness to respond to emerging public health priorities (opioid overdose epidemic, potential consequences of marijuana legalization, changing healthcare landscape, emerging drug trends, etc.)Unifying ThemesUnifying themes A number of unifying themes that will be addressed across each of the domains listed above include:Promoting research that considers the impact of sex and gender on drug abuse and addictionAddressing health disparities among underrepresented populationsUnderstanding the role of development across the life spanAddressing the treatment needs of adolescents and pregnant and post-partum womenAddressing the treatment and prevention needs related to common co-morbidities including HIV/AIDSIn collaboration with CDC and HRSA, it is critical that NIDA help establish / bolster the evidence base demonstrating the ability of persons who use drugs to adhere to medications for infectious diseases such as HIV, tuberculosis, and hepatitis C. While it would seem that some of this research does exist, many states have nonetheless implemented policies limiting access to life-saving hepatitis C treatment to those who cannot prove they have been abstinent from all illicit drugs for at least six months, despite the lack of evidence for such policies. In collaboration with CDC, it is also critical that NIDA help establish models for using multidisciplinary programs to prevent hepatitis C among young injectors, through a combination of medication assisted treatment, syringe access, antiviral treatment, and education. In collaboration with CDC (and perhaps the Bureau of Prisons), it would be great if NIDA could support a proof of concept to treat a finite group of persons with HCV, such as in a prison setting, to interrupt secondary transmission at the population level
  • RESPONSE TO NIDA REQUEST FOR INFORMATION-NIDA Strategic Directions SOCIETY FOR PREVENTION RESEARCH General ObservationsEach year, over six million young people receive treatment for mental, emotional, or behavioral problems. The financial costs for treatment services and lost productivity attributed to the related behavioral health problems of depression, conduct disorder, and substance abuse are estimated at $247 billion per year (O'Connell ME, Boat T, Warner, 2009; Woolf). These costs are for a system that only reaches a small portion of those in need of treatment.  While treatment of existing problems remains a critical service and focus of behavioral health care, over 40 years of research shows that we can prevent substance abuse and behavioral health problems from developing in the first place (Catalano, Fagan, Gavin, Greenberg, Irwin, Ross, Shek, 2012). We must increase that focus to have substantial impact on rates of disorder and related harm. The Institute of Medicine report on prevention (O’Connell et al., 2009) documents numerous controlled trials of interventions across development that have shown prevention of substance abuse and related problems is possible. Many of these interventions exhibit effects long after intervention exposure. Most provide a significant return on investment in terms of reduced personal and societal costs (Biglan, 2015). Further, young people exposed to the highest levels of risk factors, including disproportionately low-income and/or youth of color, frequently benefit most from preventive interventions.(Hill, Bailey, Hawkins et al., 2014; Campbell, Ramey, Pungello, Sparling, Miller-Johnson, 2002; Clark, Cornelius, Kirisci, Tarter, 2005; Conduct Problems Prevention Research Group, 2014) Prevention of drug abuse, alcohol misuse and other addictions differs from most other diseases and disorders in that initiation of substance use is a socially-determined behavior. Drug use, abuse and addiction develop in a complex context of diverse psychological and behavioral precursors. Research shows that modifying one or more risk or protective factors for these problems often has additional benefits in preventing other problems such as mental health problems, aggression, and academic failure. Thus, preventive interventions can be highly efficient in addressing multiple social problems and their associated costs.NIDA funding has been essential in building the prevention science that has led these accomplishments, creating a diverse portfolio that includes basic research, methodology, efficacy trials, effectiveness research, systems research, and services research. The report on prevention from the Institute of Medicine (O’Connel, et al., 2009) highlights the contribution that NIDA has made to the progress of prevention research. Their conclusion is clear: the most effective way to halt the manifestation of substance use and allied behavioral health disorders is through prevention. Despite this, prevention intervention research remains a small portion of the NIDA portfolio, only 8% in 2012.  A continued focus on and increased funding for prevention studies are imperative to improve population health. Prevention needs to play a more prominent role in the proposed 2015 NIDA strategic plan. Despite this accumulation of core prevention research, there remains much to be learned to further improve the prevention knowledge base. I suggest three broad prevention priorities be incorporated into the NIDA 2015 strategic plan: 1) prevention- related basic research to discover and specify the mechanisms of action of biopsychosocial risk and protective factors and their interaction across development; 2) prevention intervention research to develop and test new interventions that extend existing efficacy research, test emerging findings about biopsychosocial risk, specify how intervention effects are realized and for whom effects apply, and understand the salutary effects of substance abuse prevention on related problems ; and 3) research to understand how best to “scale up” (adoption, implementation, and sustainability) effective prevention intervention with reach and fidelity to achieve population-wide reductions in substance use, abuse and addiction, with related economic and health gains to individuals, families, communities, and state and federal governments. Specific suggestions are made below and denoted by a vertical line in the left margin.Basic Research: The current Strategic Priorities recognize the importance of biological science to understanding substance use, abuse and addiction.  However, the priorities underemphasize the critical role of social and behavioral science in understanding and addressing these problems. I suggest that a revision is made to include both Neuroscience and Social and Behavioral research in their own subsections of Basic Research.Neuroscience: Improve our understanding of the basic science of drug use, addiction, vulnerability to addiction, and recovery Increase our knowledge of biological , behavioral, environmental, and developmental factors involved in risk and resilience for drug use and addictionIntegrating animal models, behavior, genetics, epigenetics, and other molecular biomarkers for drug abuse and addictionUnderstand the developmental trajectory of substance use, abuse, and addiction and individual heterogeneityImprove our understanding of brain circuits related to drug use, abuse and addiction at the cellular, circuit, and connectome levels, including:Normal development and function across the lifespan including mechanisms of reward, self-control, and conditioningDrug effects on neuroplasticity, neural structure, and circuit function across the stages of addictionNeurobiological correlates of recoveryNeural-glial, -immune, and neuroendocrine interactionsBetter define the interactions between substance use, abuse, and addiction and pain, including molecular, genetic, behavioral , and neural-circuit-related factors, to guide the development of alternate treatment strategies for pain patientsImprove our understanding of the interaction between substance use, abuse, and addiction and co-occurring conditions Elucidate the impact of mental health, HIV, HCV, pain, etc. on addiction; Understand molecular mechanisms of latent HIV reservoirs in the brains of substance-abusing populationsBiological processes related to substance use, abuse and addiction risk and resilience and reactivity to preventive interventionsSocial and Behavioral Research: Research suggests that despite biological predispositions, the decision to use drugs is environmentally triggered, and that socio-cultural environments (e.g., policy, peers, family, communities) play pivotal roles in the initiation, maintenance, and desistence from drug use, abuse, and dependence. Understanding the developmental and environmental influences on biological mechanisms will increase the likelihood that biological research will strengthen efforts at prevention and treatment to improve the public health.Increase our knowledge of social, environmental and developmental predictors of substance use, abuse and addiction.Increase our knowledge of interactions between biological mechanisms and social, environment and developmentally salient predictors of later substance use, abuse, and addiction.Increase understanding of neurobiological changes in response to prevention interventions and messages.Determine the mechanistic effects of programs and interventions which will provide an evidence-base to guide efforts to refine and improve program components. Explore basic, malleable conditions that promote or interfere with intervention effects.Increase understanding of interaction effects of stress and contextual factors on drug abuse risk.Expand research on the relationships between drug use, abuse, and addiction on communicable and non-communicable diseases.Clinical and Translational Science: Support the development of new and better preventive interventions and treatments.  that incorporate the diverse needs of individuals at risk for the development of and those with Substance Use Disorders (SUDs) Treatment research is important but reducing the number of those who contract the disorder is also critical. In addition, treatment and prevention have some distinct operational, population assumptions, and likely mechanisms of effects that merit separate but substantial attention (Weisz, Sandler, Durlak, & Anton, 2005). I suggest separate sections on Treatment and Prevention Research.Treatment Research: Support the development of novel, evidence-based, treatment interventions including social, behavioral, cognitive, pharmacological, vaccines, and brain stimulation therapies (e.g., transcranial magnetic stimulation, direct current stimulation, etc.)Accelerate the identification of promising targets and ligands to accelerate new drug discovery and development Accelerate medications development for SUDsFocused development efforts on: Addictions without an FDA approved treatmentDetoxificationOverdose prevention or reversalAccelerating neurobiological recoveryAddressing comorbidities (MH, HIV, HCV, pain)Develop techniques to measure and improve patient compliance in clinical trialsIdentify measures other than abstinence that can reliably assess SUD treatment outcomes Identify biomarkers of addiction, resilience, and recovery to enable personalized treatmentUsing pooled data from previous evidence-based treatment trials, identify mechanisms and moderators of intervention efficacyPrevention Research Integrate discoveries from the basic biological (e.g. neurobiological), psychological (e.g. emotional, behavioral, cognitive, and developmental) and social (e.g. social learning, peer network, and communications, laws and norms) sciences to develop and test innovative preventive interventions that specifically target underlying mechanisms in drug abuse risk.Research what are critical windows during childhood to adulthood that may produce the greatest effects for specific types of preventive interventions. Increase the translation of knowledge about basic biological, genetic, and neurobiological mechanisms underlying drug use and abuse to serve as indicators of change in preventive intervention research, and/or to help determine the intervention course (psychosocial, psychopharmacological) that is most likely to be effective for an individual given underlying biological mechanisms of action.Increase research to fill critical gaps in understanding the impact of preventive intervention on vulnerable populations including low income, people of color, youth in the child welfare system.Increase research to determine the impact of preventive interventions utilizing new and emerging electronic communication technologies. In addition to efficacy of utilizing these technologies for delivery of preventive interventions, the reach (who accesses), and the usefulness of these modes of delivery for generalization and maintenance of intervention impact is needed.Increase research to identify malleable mediators and moderators of preventive intervention effects to better understand which interventions work best for whom and why, and what preventive components predict intervention effects to understand how to improve prevention effects for all.Increase research to understand what malleable underlying person or environmental conditions interfere with or promote intervention effects.Increase research to examine the impact of preventive interventions on the neural substrate level. An understanding of how an effective intervention can alter brain development and function is critical for the field.Increase research to replicate effective prevention interventions in new populations and under different conditions to understand what contributes to whether the intervention continues to be effective or is less effective. Further, research is needed on the impact of fidelity, quality, and adaptation on the effectiveness of replications.Increase research on the combination of behavioral and biomedical preventive intervention.Increase research to incorporate understanding of individual differences in response to different types of persuasion and different types of drugs in preventive intervention development.  This includes further culturally-sensitive and responsive research for understanding the needs of vulnerable and high risk populations. Increase research on embedding efficacious or new prevention interventions in health care organizations to examine the impact on health costs and a range of substance related outcomes at population level. Public Health: Increase the public health impact of NIDA research and programs: A substantial research agenda is needed on the complex processes through which evidence-based interventions are adopted, implemented, and sustained at the community level, with a strong orientation toward devising empirically-driven strategies for increasing their population impact.  This agenda fits with recommendations in the National Prevention Strategy including the dissemination of community-based interventions that address health inequities, especially in inner-city neighborhoods and rural areas, the development, testing, and implementation of effective strategies to engage underserved populations, and the organization of representative, multi-sector community partnerships.Improve the understanding of factors that influence the integration of evidence-based basic science, prevention and treatment research findings into healthcare policy and practice (implementation science)Increase the understanding of how organizational, leadership, and fiscal factors influence the adoption and sustainment of evidence-based practices to prevent and treat substance use and abuse in key public service sectors (mental health, health, justice, child welfare)Improve the understanding of factors that influence the integration and sustainability of evidence-based basic research, prevention and treatment research findings into state and local public health, behavioral health, education, and child welfare, and maternal health.Increase dissemination research efforts of evidence based prevention programs and policies to determine what works best, for whom and why so that programs and policies can be further refined to achieve optimal results to improve the public healthIncrease research to understand the needed elements of infrastructure development to ensure the capacity and necessary supports for large scale adoption, implementation and sustainability of evidence based preventive and treatment interventions.Increase research on training health care and other providers in prevention knowledge and practices.  Increase research to understand the cost of effective preventive interventions as well as the economic benefits that follow, to facilitate uptake and support for investing in prevention by policymakers and funders.Increase readiness to respond to emerging public health priorities (opioid overdose epidemic, potential consequences of marijuana legalization, new populations (elderly), changing healthcare landscape, emerging drug trends, etc.)Increase strategic partnerships with the community (academia, pharma, biotech, healthcare organizations, policy makers, etc.) to enhance the dissemination of evidence-based research findings into policy and practice Strengthen focus on bi-directional translational researchScience Infrastructure: Enhance the national research infrastructure to support advancements in scienceAccelerate the development and utilization of advanced technologies (e.g. the President’s BRAIN Initiative), data repositories (e.g. Big Data to Knowledge (BD2K) initiative, new technology for intervention delivery, and statistical models to spur innovative research Develop a strategy to build a strong infrastructure (building both manpower and organizational capacity) to support the dissemination, diffusion and quality implementation of evidence-based prevention practices that range from screening and assessment of vulnerable populations and communities to the appropriate recommendations for prevention programming and monitoring.Improve training for the next generation of scientistsIncrease effective engagement and training in multidisciplinary research (informatics, engineering, computer science, chemistry, mathematics, physics, etc.)Increase the number of well-trained underrepresented scientists in the drug abuse and addiction field at all career levelsImprove mentoring of young scientistsIncrease effective collaborations in researchIncrease the transparency of researchIncrease effective data and resource sharing (big data, biorepositories, transgenic/optogenetic tools, data standards, etc.)Increase collaborations with other NIH Institutes and Centers (e.g. Collaborative Research on Addiction at NIH (CRAN)), Federal and State agencies, academic and industry partners, etc. Create opportunities for multiple federal agencies to collaborate in funding translational drug abuse prevention and treatment research; e.g., SAMSHA, ONDCP, OJJDP, CYF, MCH, etc.Increase opportunities for combining data from previous prevention and treatment trials and use innovative methods to integrate and analyze these data.Identify and implement strategies to improve the reproducibility of pre-clinical researchEnable efficiency and lower the cost of clinical trials via innovative statistical models, data standards, leveraging technology (e.g. electronic health records) and partnerships, etc.Develop and validate computational and systems-level analytics for integrating multi-dimensional data across the addiction trajectoryUnifying themes:  A number of unifying themes that will be addressed across each of the domains listed above include:Promoting research that considers the impact of sex and gender on drug abuse and addictionUnderstanding the interrelation between preventive and treatment interventions affecting substance abuse and impact on other aspects of physical and mental health, social functioning, and productivityAddressing health disparities among underrepresented populationsUnderstanding the role of development across the life spanAddressing the treatment needs of adolescents and pregnant and post-partum womenAddressing the treatment and prevention needs related to common co-morbidities including HIV/AIDSAddressing the prevention needs of youth and high-risk populations.Understanding the implications of the changing drug policy environment (i.e., marijuana legalization at the state level)Understanding the developmental and contextual influences across all areas of research ReferencesBiglan, A (2015) The Nurture Effect: The Evolution of Behavioral Science, Psychology Today, 1/5/15. Campbell FA, Ramey CT, Pungello E, Sparling J, Miller-Johnson S. (2002) Early childhood education: Young adult outcomes from the Abecedarian Project. Appl Dev Sci, 6(1):42-57.Catalano, R. F., Fagan, A. A., Gavin, L. E., Greenberg, M. T., Irwin, C. E., Ross, D. A., & Shek, D. T. L. (2012). Worldwide application of the prevention science research base in adolescent health. Lancet, 379, 1653-1664.Clark DB, Cornelius JR, Kirisci L, Tarter RE. (2005) Childhood risk categories for adolescent substance involvement: A general liability typology. Drug Alcohol Depend. 77(1):13-21.Conduct Problems Prevention Research Group. (2014). Impact of early intervention on psychopathology, crime, and well-being at age 25. Am J Psychiatry..Hale DR, Fitzgerald-Yau N, Mark Viner R. (2014) A systematic review of effective interventions for reducing multiple health risk behaviors in adolescence. Am J Public Health.104(5).Hawkins JD. (2006) Science, social work, prevention: Finding the intersections. Soc Work Res. 30(3):137-152.Hill KG, Bailey JA, Hawkins JD, et al. (2014) The onset of STI diagnosis through Age 30: Results from the Seattle Social Development Project intervention. Prev Sci.;15 (Suppl 1):S19-S32.O'Connell ME, Boat T, Warner KE, editors. (2009) Preventing mental, emotional, and behavioral disorders among young people: Progress and possibilities. Washington, DC: National Academies Press.Sloboda, Z. (2012) Substance Use & Misuse, 47:1557–1568, 2012.Western B, Pettit B. (2010) Incarceration & social inequality. Daedalus. 139(3):8-19,146-147.Woolf SH. (2008) The power of prevention and what it requires. JAMA. 299(20):2437-2439.
  • If concerns over the rising costs of health care persist and remain important for most Americans, then support and investment for evidence-based prevention interventions is both warranted and indispensable. Unfortunately, and too often, American society’s response to major problems  has been mostly reactive. Such responses have evolved out of understandable efforts to deal with problems once they have emerged. We have devised a treatment system for most of the common and costly substance use and allied psychological and behavioral disorders once   these problems have developed. Some of these policies have actually increased social inequity (Western & Petit, 2010). Each year, over six million young people receive treatment for mental, emotional, or behavioral problems. The financial costs for treatment services and lost  productivity attributed to the related behavioral health problems of depression, conduct disorder, and substance abuse are estimated at $247 billion per year (O'Connell ME, Boat T, Warner, 2009; Woolf). These costs are for a system that only reaches a small portion of those in need of treatment. While treatment of existing problems remains a critical service and focus of behavioral health care, there is widespread recognition and empirical evidence from over 40 years of research that we can prevent substance abuse and behavioral health problems from developing in the first place (Catalano, Fagan, Gavin, Greenberg, Irwin, Ross, Shek, 2012. We must increase that focus to have substantial impact on rates of disorder and related harm. Major advances in reducing the incidence and prevalence of addiction and behavioral health problems become possible with the continued development of prevention science and the opportunities   for more integration of prevention into health care through the Affordable Care Act. The Institute of Medicine report on prevention (O’Connell et al., 2009) documents numerous controlled trials  of interventions across development that have shown prevention of substance abuse and  related problems is possible. Many of these interventions exhibit effects long after intervention exposure. And, most provide a significant return on investment in terms of reduced personal   and societal costs. (Biglan, 2015).NIDA funding has been essential in building the prevention science that has led these accomplishments, creating a diverse portfolio that encompasses basic research, methodology, efficacy trials, effectiveness research, systems research, and services research. The report on prevention from the Institute of Medicine (O’Connell, et al., 2009) highlights the contribution that NIDA has made to the progress of prevention research. Their conclusion is clear: the most effective way to halt the manifestation of substance use and allied behavioral health disorders is through prevention. We think that the emphasis on prevention in the NIDA 2010 strategic plan reflects acknowledgement of this viewpoint, that prevention be a major emphasis. Despite this, prevention intervention research remains a small portion of the NIDA portfolio, 8% in 2012,  which is less than half the proportion allotted to treatment intervention research (17%). This is a decrease of 20% of the NIDA prevention portfolio from 2011 to 2012 (Sloboda, 2012; 1564). We think that increasing, not decreasing, the percentage devoted to prevention studies is imperative to continue the quality and quantity of research to fulfill this goal in the strategic plan and for continued progress in population health. Prevention needs to play a more prominent role in the proposed 2016-2020 NIDA strategic plan.We also think increased funding is justified to support the multi-focused portfolio that has  spurred the important advances in the past two decades by providing ongoing and efficient feedback from epidemiology to basic descriptive studies to intervention designs and test of efficacy, effectiveness, and readiness for to-scale implementation. This funding has contributed more robust and rapidly innovating evidence base for basic research, substance abuse prevention, as well as treatment research. Research results examining bio-behavioral- developmental interactions have underscored the importance of the inter-relation between these mechanisms and the environment. Prevention of drug abuse, alcohol misuse and other addictions differs from most other diseases and disorders in that, at the initiation stage, substance use is well-characterized as a socially-determined behavior; there is a choice to use   a particular substance. The notion of choice is complex and influences and information vary by life stage. The combined portfolio approach has produced research that demonstrates that drug use, abuse and addiction develops in a complex context of diverse psychological and behavioral precursors; thus, guiding prevention that modifies one or more risk or protective factors for   these problems and also showing that such prevention often has additional benefits in  preventing other problems such as mental health problems, aggression, and school achievement.Prevention research has also revealed that such efforts may have biggest effects where risk is greatest and opportunity or protection scarcer. Young people exposed to the highest levels of risk factors, including disproportionately low-income and/or youth of color, frequently benefit most from preventive interventions (Hill, Bailey, Hawkins et al., 2014; Campbell, Ramey, Pungello, Sparling, Miller-Johnson, 2002; Clark, Cornelius, Kirisci, Tarter, 2005; Conduct Problems Prevention Research Group, 2014).Despite this accumulation of core prevention research, there remains much to be learned to further improve the prevention knowledge base. Below, within in the basic bullet points of the Request For Information on NIDA’s strategic plan, we have added important and poorly understood aspects of prevention that require additional rigorous research. Structurally, we strongly suggest the augmentation of the Basic Research area to include both biological and social environmental research and the augmentation of the clinical and translational research to include a prevention section in addition to the treatment section. We detail what we think are the strategic areas for research in these new sections and provide comments (in red) on the  existing document.In general, we suggest three broad prevention priorities incorporated into the NIDA 2016-2020 strategic plan: 1) prevention-informed and related basic research to discover and specify the mechanisms of biopsychosocial risks and protective factors and their interaction across development; 2) prevention intervention research to develop and test new interventions that extend the comprehensiveness of existing efficacy research, test emerging findings about biopsychosocial risk, specify how intervention effects are realized and for whom effects apply, and understand the salutary effects of substance abuse prevention on related problems; and 3) research to understand how best to “scale up” (adoption, implementation, and sustainability) effective prevention intervention with reach and fidelity to achieve population-wide reductions in substance use, abuse and addiction, with related economic and health gains to individuals, families, communities, and state and federal government. This includes development and testing of efficient and effective modes of intervention delivery, as well as understanding how to integrate these effective preventive interventions into routine service delivery systems from health care and education to child welfare and mental health services. In addition, research tounderstand the role of substance use, abuse and addiction prevention as part of the Affordable Care Act and in regulatory efforts to affect substance use and other related problems is needed.Basic Research: The current Strategic Priorities recognize the importance of biological science to understanding substance use, abuse and addiction. However, the priorities underemphasize the critical role of social and behavioral science in understanding and addressing these problems. We suggest that a revision is made to include both Neuroscience and Social and Behavioral research in their own subsections of Basic Research.Neuroscience: Improve our understanding of the basic science of drug use, addiction, vulnerability to addiction, and recovery (SPR’s edits to NIDA’s draft strategic plan are highlighted in red.)Increase our knowledge of biological , behavioral, environmental, and developmentalfactors involved in risk and resilience for drug use and addictionIntegrating animal models, behavior, genetics, epigenetics, and other molecular biomarkers for drug abuse and addictionUnderstand the developmental trajectory of substance use, abuse, and addiction and individual heterogeneityImprove our understanding of brain circuits related to drug use, abuse and addiction at the cellular, circuit, and connectome levels, including:Normal development and function across the lifespan including mechanisms of reward, self-control, and conditioningDrug effects on neuroplasticity, neural structure, and circuit function across the stages of addictionNeurobiological correlates of recoveryNeural-glial, -immune, and neuroendocrine interactionsBetter define the interactions between substance use, abuse, and addiction and pain, including molecular, genetic, behavioral , and neural-circuit-related factors, to guide the development of alternate treatment strategies for pain patientsImprove our understanding of the interaction between substance use, abuse, and addiction and co-occurring conditionsElucidate the impact of mental health, HIV, HCV, pain, etc. on addiction;Understand molecular mechanisms of latent HIV reservoirs in the brains of substance- abusing populationsBiological processes related to substance use, abuse and addiction risk and resilienceand reactivity to preventive interventionsSocial and Behavioral Research: Research suggests that despite biological predispositions, the decision to use drugs is environmentally triggered, and that socio-cultural environments (e.g., policy, peers, family, communities) play pivotal roles in the initiation, maintenance, and desistence from drug use, abuse, and dependence. Further, evidence has demonstrated that the impact of preventive interventions on biological processes or predispositions is also important to study. We expect that there is an interplay of environmental and biological influences in the development of addiction. Understanding the relative contribution and mechanisms of change are critical to understanding the development of substance use, abuse, and addiction. Understanding the developmental and environmental influences on biological mechanisms will increase the likelihood that biological research will strengthen efforts at prevention and treatment to improve the public health.Increase our knowledge of social, environmental and developmental predictors of substance use, abuse and addiction.Increase our knowledge of interactions between biological mechanisms and social, environment and developmentally salient predictors of later substance use, abuse, andaddiction.Increase understanding of neurobiological changes in response to prevention interventions and messages.Determine the mechanistic effects of programs and interventions which will provide an evidence-base to guide efforts to refine and improve program components. Explorebasic, malleable conditions that promote or interfere with intervention effects.Increase understanding of interaction effects of stress and contextual factors on drug abuse risk.Expand research on the relationships between drug use, abuse, and addiction on communicable and non-communicable diseases.Clinical and Translational Science: Support the development of new and better preventive interventions and treatments. that incorporate the diverse needs of individuals at risk for the development of and those with Substance Use Disorders (SUDs) Treatment research is important but reducing the number of those who contract the disorder is also critical. In addition, treatment and prevention have some distinct operational, population assumptions, and likely mechanisms of effects that merit separate but substantial attention (Weisz, Sandler, Durlak, & Anton, 2005). We suggest separate sections on Treatment and Prevention Research.Treatment Research: Support the development of novel, evidence-based, treatment interventions including social, behavioral, cognitive, pharmacological, vaccines, and brain stimulation therapies (e.g., transcranial magnetic stimulation, direct current stimulation, etc.)Accelerate the identification of promising targets and ligands to accelerate new drug discovery and developmentAccelerate medications development for SUDsFocused development efforts on:Addictions without an FDA approved treatmentDetoxificationOverdose prevention or reversalAccelerating neurobiological recoveryAddressing comorbidities (MH, HIV, HCV, pain)Develop techniques to measure and improve patient compliance in clinical trialsIdentify measures other than abstinence that can reliably assess SUD treatment outcomes Identify biomarkers of addiction, resilience, and recovery to enable personalized treatmentUsing pooled data from previous evidence-based treatment trials, identify mechanisms and moderators of intervention efficacyPrevention ResearchIntegrate discoveries from the basic biological (e.g. neurobiological), psychological (e.g. emotional, behavioral, cognitive, and developmental) and social (e.g. social learning, peer network, and communications, laws and norms) sciences to develop and test innovative preventive interventions that specifically target underlying mechanisms in drug abuse risk.Research what are critical windows during childhood to adulthood that may produce the greatest effects for specific types of preventive interventions.Increase the translation of knowledge about basic biological, genetic, and neurobiological mechanisms underlying drug use and abuse to serve as indicators ofchange in preventive intervention research, and/or to help determine the intervention course (psychosocial, psychopharmacological) that is most likely to be effective for an individual given underlying biological mechanisms of action.Increase research to fill critical gaps in understanding the impact of preventive intervention on vulnerable populations including low income, people of color, youth in thechild welfare system.Increase research to determine the impact of preventive interventions utilizing new and emerging electronic communication technologies. In addition to efficacy of utilizing these technologies for delivery of preventive interventions, the reach (who accesses), and the usefulness of these modes of delivery for generalization and maintenance of intervention impact is needed.Increase research to identify malleable mediators and moderators of preventive intervention effects to better understand which interventions work best for whom and why, and what preventive components predict intervention effects to understand how to improve prevention effects for all.Increase research to understand what malleable underlying person or environmental conditions interfere with or promote intervention effects.Increase research to examine the impact of preventive interventions on the neural substrate level. An understanding of how an effective intervention can alter braindevelopment and function is critical for the field.Increase research to replicate effective prevention interventions in new populations and under different conditions to understand what contributes to whether the intervention continues to be effective or is less effective. Further, research is needed on the impact of fidelity, quality, and adaptation on the effectiveness of replications.Increase research on the combination of behavioral and biomedical preventive intervention.Increase research to incorporate understanding of individual differences in response to different types of persuasion and different types of drugs in preventive interventiondevelopment. This includes further culturally-sensitive and responsive research for understanding the needs of vulnerable and high risk populations.Increase research on embedding efficacious or new prevention interventions in health care organizations to examine the impact on health costs and a range of substancerelated outcomes at population level.Public Health: Increase the public health impact of NIDA research and programs: A substantial research agenda is needed on the complex processes through which evidence-based interventions are adopted, implemented, and sustained at the community level, with a strong orientation toward devising empirically-driven strategies for increasing their population impact. This agenda fits with recommendations in the National Prevention Strategy including the dissemination of community-based interventions that address health inequities, especially in inner-city neighborhoods and rural areas, the development, testing, and implementation of effective strategies to engage underserved populations, and the organization of representative, multi-sector community partnerships.Improve the understanding of factors that influence the integration of evidence-based basic science, prevention and treatment research findings into healthcare policy and practice (implementation science)Increase the understanding of how organizational, leadership, and fiscal factors  influence the adoption and sustainment of evidence-based practices to prevent and treat substance use and abuse in key public service sectors (mental health, health, justice, child welfare)Improve the understanding of factors that influence the integration and sustainability of evidence-based basic research, prevention and treatment research findings into stateand local public health, behavioral health, education, and child welfare, and maternalhealth.Increase dissemination research efforts of evidence based prevention programs and policies to determine what works best, for whom and why so that programs and policies can be further refined to achieve optimal results to improve the public healthIncrease research to understand the needed elements of infrastructure development to ensure the capacity and necessary supports for large scale adoption, implementation and sustainability of evidence based preventive and treatment interventions.Increase research on training health care and other providers in prevention knowledge and practices.Increase research to understand the cost of effective preventive interventions as well asthe economic benefits that follow, to facilitate uptake and support for investing in prevention by policymakers and funders.Increase readiness to respond to emerging public health priorities (opioid overdose epidemic, potential consequences of marijuana legalization, new populations (elderly), changing healthcare landscape, emerging drug trends, etc.)Increase strategic partnerships with the community (academia, pharma, biotech, healthcare organizations, policy makers, etc.) to enhance the dissemination of evidence- based research findings into policy and practiceStrengthen focus on bi-directional translational researchScience Infrastructure: Enhance the national research infrastructure to support advancements in scienceAccelerate the development and utilization of advanced technologies (e.g. the President’s BRAIN Initiative), data repositories (e.g. Big Data to Knowledge (BD2K) initiative, new technology for intervention delivery, and statistical models to spur innovative researchDevelop a strategy to build a strong infrastructure (building both manpower and organizational capacity) to support the dissemination, diffusion and quality implementation of evidence-based prevention practices that range from screening and assessment of vulnerable populations and communities to the appropriate recommendations for prevention programming and monitoring.Improve training for the next generation of scientistsIncrease effective engagement and training in multidisciplinary research (informatics, engineering, computer science, chemistry, mathematics, physics, etc.)Increase the number of well-trained underrepresented scientists in the drug abuse and addiction field at all career levelsImprove mentoring of young scientistsIncrease effective collaborations in researchIncrease the transparency of research Increase effective data and resource sharing (big data, biorepositories, transgenic/optogenetic tools, data standards, etc.)Increase collaborations with other NIH Institutes and Centers (e.g. Collaborative Research on Addiction at NIH (CRAN)), Federal and State agencies, academic and industry partners, etc.Create opportunities for multiple federal agencies to collaborate in funding translational drug abuse prevention and treatment research; e.g., SAMSHA, ONDCP, OJJDP, CYF, MCH, etc.Increase opportunities for combining data from previous prevention and treatment trials and use innovative methods to integrate and analyze these data.Identify and implement strategies to improve the reproducibility of pre-clinical researchEnable efficiency and lower the cost of clinical trials via innovative statistical models, data standards, leveraging technology (e.g. electronic health records) and partnerships, etc.Develop and validate computational and systems-level analytics for integrating multi- dimensional data across the addiction trajectoryUnifying themes: A number of unifying themes that will be addressed across each of the domains listed above include:Promoting research that considers the impact of sex and gender on drug abuse and addictionUnderstanding the interrelation between preventive and treatment interventions affecting substance abuse and impact on other aspects of physical and mental health, social functioning, and productivityAddressing health disparities among underrepresented populationsUnderstanding the role of development across the life spanAddressing the treatment needs of adolescents and pregnant and post-partum womenAddressing the treatment and prevention needs related to common co-morbidities including HIV/AIDSAddressing the prevention needs of youth and high-risk populations.Understanding the implications of the changing drug policy environment (i.e., marijuana legalization at the state level)Understanding the developmental and contextual influences across all areas of research ReferencesBiglan, A (2015) The Nurture Effect: The Evolution of Behavioral Science, Psychology Today, 1/5/15.Campbell FA, Ramey CT, Pungello E, Sparling J, Miller-Johnson S. (2002) Early childhood education: Young adult outcomes from the Abecedarian Project. Appl Dev Sci, 6(1):42-57. Catalano, R. F., Fagan, A. A., Gavin, L. E., Greenberg, M. T., Irwin, C. E., Ross, D. A., & Shek,D. T. L. (2012). Worldwide application of the prevention science research base in adolescent health. Lancet, 379, 1653-1664.Clark DB, Cornelius JR, Kirisci L, Tarter RE. (2005) Childhood risk categories for adolescentsubstance involvement: A general liability typology. Drug Alcohol Depend. 77(1):13-21. Conduct Problems Prevention Research Group. (2014). Impact of early intervention on psychopathology, crime, and well-being at age 25. Am J Psychiatry..Hale DR, Fitzgerald-Yau N, Mark Viner R. (2014) A systematic review of effective interventions for reducing multiple health risk behaviors in adolescence. Am J Public Health.104(5).Hawkins JD. (2006) Science, social work, prevention: Finding the intersections. Soc Work Res. 30(3):137-152.Hill KG, Bailey JA, Hawkins JD, et al. (2014) The onset of STI diagnosis through Age 30: Results from the Seattle Social Development Project intervention. Prev Sci.;15 (Suppl 1):S19-S32.O'Connell ME, Boat T, Warner KE, editors. (2009) Preventing mental, emotional, and behavioral disorders among young people: Progress and possibilities. Washington, DC: National Academies Press.Sloboda, Z. (2012) Substance Use & Misuse, 47:1557–1568, 2012.Western B, Pettit B. (2010) Incarceration & social inequality. Daedalus. 139(3):8-19,146-147. Woolf SH. (2008) The power of prevention and what it requires. JAMA 299(20):2437-2439
  • Faces & Voices of Recovery is pleased to provide input on the 2016- 2020 draft strategic priorities as well as general recommendations that will sustain recent advances and accelerate discovery in addiction recovery research over the next five years. The following response reflects the views of the organization and membership as a whole.Suggested changes or additions to the list of strategic priorities, including emerging research needs and future opportunities that should be considered in the planChanges (underlined)Basic Neuroscience: Improve our understanding of the basic science of drug use, addiction, vulnerability to addiction, and the recovery process and increase our knowledge of biological, behavioral, environmental, and developmental factors involved in risk, resilience and recovery for drug use and addiction.Neurobiological correlates of recovery: Focus on the neuroplasticity properties with treatment and recovery supports that facilitate neural responses in recovery. How do environmental supports for resiliency enhance neural development in recovery?Improve our understanding of the interaction between addiction and co-occurring conditions and its impact on the recovery process. (With the shame and stigma associated with both addiction and mental health, is there a way to assess the differences in public perception, and the effect of addiction being seen more as a “choice”? Also what are the environmental andcultural differences leading to relapse, such as the right to refuse medication, over-prescribing of narcotics, beer sales, etc.)Support the development of novel, evidence-based, targeted prevention, treatment and recovery support interventions including social, behavioral, pharmacological, vaccines, and brain stimulation therapies (e.g., transcranial magnetic stimulation, direct current stimulation, etc.)Improve training for the next generation of scientists – including training on the Science of Addiction and Recovery (SOAR).Promoting research that considers the impact of sex and gender on drug abuse, addiction and the recovery process.Addressing the treatment, prevention and recovery needs related to common co-morbidities including HIV/AIDS.Identify measures other than abstinence that can reliably assess SUD treatment and recovery support services outcomes Identify biomarkers of addiction, resilience, and recovery to enable personalized treatment.AdditionsAddressing the needs of people seeking recovery in areas bereft of recovery supports (ie rural areas) such as the efficacy of online resources where there is no significant recovery community.Measure the presence, depth, and effect of stigma as a barrier to treatment and recovery, including perceived shame for relapse within the recovery community.The effect of marginalizing some types of treatment or pathways to recovery (specifically medication assisted treatment) within the recovery community.Additional research needs to be conducted to build the evidence base about the effectiveness of peer-delivered support and peer-delivered support services in both the mental health and addictions fields.More research is needed on matching individuals with the type of peer-delivered recovery support that best fits with their stage of recovery and their personal goals to improve our understanding of the most essential types of support at different stages of recovery. Factors such as age group, gender, self-identity, motivation to change, health and mental health status, and spirituality should be considered.Explore qualitatively how peer support and clinical care can complement each other.Examine people in recovery’s responses to peer support and how it influences recovery over time.Examine how integrating peer support workers contributes to aspects of the environmental context of a behavioral health program.Improve the rigor of research on the effectiveness of training programs for peer support workers, using control or comparison groups, and whenever possible randomized controlled trials.The scientific rationale for the changes or ideas proposed and the anticipated impact on advancing the science of drug abuse and addictionWhy Study Recovery?Recovery from substance use is a reality for millions of people worldwide.Addiction is a chronic disorder; addressing addiction and recovery requires that clinicians and researchers adopt a long-term approach.We know a great deal about addiction, but very little about recovery.Recovery is a lifelong process that may involve a succession of “stages” making changing demands on the individual.Most research on substance use adopts an ‘acute’ perspective to addiction, typically using short follow-up periods (e.g., 1 to 24 months).Therefore, most available data bear only on recovery initiation, a period that is short relative to the lifelong challenges of recovery.Little is known about temporal patterns of recovery over time or about predictors of long-term recovery (recovery consolidation and maintenance).Few studies provide data on outcomes beyond abstinence. Other outcomes of interest might include: housing and work status, quality of life, functioning, mental health status, and support networks.Anticipated challenges that will need to be addressed to achieve these prioritiesThe evidence base for peer-delivered recovery support services in behavioral health is growing and demonstrates that these services have a salutary effect and are an important component of the continuum of recovery support. To strengthen this evidence base, it is critical to take steps to improve the quality and methodological rigor of the research. We propose developing a national research agenda to better understand the nature, contributions, effectiveness, and cost-effectiveness of peer- delivered recovery support services.Appropriate benchmarks for gauging progress toward each recommended priorityFuture research must include greater detail and description of the peer role and peer qualifications.Future research needs to include more complete descriptions of peer-delivered services including recovery coaching, recovery community centers, telephone-based peer support; and how of the service/support elements being delivered (e.g., “one-to-one contacts to accompany peers to critical appointments,” “group sessions focused on stigma”). This includes more complete descriptions of the peers delivering services, including the demographic characteristicsof the peer support specialists/recovery coaches, their educational backgrounds, stage of recovery, and information about their experience, training, and credentials in delivering peer- delivered services.ConclusionIt is a critical time in the development of novel, evidence-based peer-based recovery support interventions. The Affordable Care Act (ACA) has afforded the opportunity for many recovery community organizations to explore funding from public and private insurers to provide peer-based recovery support services in community-based, non-clinical setting. Enhancing the scientific understanding of recovery and supporting the development and testing of interventions and services to reduce relapse and promote recovery from addiction will expand these opportunities for RCO’s.  The key to this success is having the research that demonstrates positive outcomes of these interventions to meet funding eligibility requirements. This is a critical time for the field to have the evidence-base for peer support in addictions. Faces & Voices of Recovery also supports prioritizing research on cost savings and cost-effectiveness of recovery support services.Thank you for the opportunity to provide feedback on NIDA’s 2016 – 2020 Draft Strategic Plan

Basic Science, Clinical and Translational Science, Public Health, Infrastructure

  • NIDA Strategic Plan 2015Comments from the National Prevention Science Coalition to Improve Lives (NPSC)Translational Prevention Science SubcommitteeDr. Diana Fishbein, ChairThe question that the drug abuse prevention sciences seeks to address is “What works best (evidence-based practices premised on basic research), for who (moderation), why (mediation by malleable conditions) and under what circumstances (developmental, experiential and contextual factors). The following is geared toward this model.  Basic Prevention Research to Guide Intervention Development (T1) Apply animal models to elucidate underlying mechanisms in psychopathology that portends drug abuse, transitions to drug abuse, and/or mechanisms in differential orientations to physical and social environments that influence risk. Design human laboratory or experimental studies to investigate whether neurochemical, structural and functional neuroanatomical, psychophysiological or other mechanisms observed in preclinical science can serve as important targets for the prevention of drug abuse in humans. Are neural substrates of novelty or sensation seeking, decision making, impulsivity, etc. identified in primate models amenable to change in response to psychosocial or environmental manipulations?Identify neurobiological underpinnings for differential susceptibility to environmental stressors or, conversely, differential responsivity to prevention programming.Determine the mechanistic effects of programs and interventions which will provide an evidence-base to guide efforts to refine and improve program components;Explore basic, malleable conditions that promote or interfere with intervention effects; i.e., study of moderation and mediation that accounts for changes at the neurocognitive or psychophysiological level that occur commensurate with behavioral change.Examine how neurobiological indices are related to the impact of interventions at critical or transition periods, including consideration of changing social contexts; e.g., studies of changing patterns of activation in cortical and subcortical circuits underlying emotional and cognitive processes in response to prevention messages, or recruited in the context of peer presence during decision making, etc.Conduct studies to ascribe a functional role to an epigenetic and/or genetic variant with respect to a particular aspect of drug abuse propensity.  Identify epigenetic and/or genetic variant effects on behavioral responses to social inputs and interventions.If the genetic makeup sets the stage for responses to environmental input, can psychosocial interventions alter: a) genetic expression of activities in underlying substrates of risk traits and b) the behavioral phenotype?  Will the outcome of this impact be sufficiently measurable in these markers?Account for the profound effects of adversity and severe and/or chronic stress on child brain development which, in turn, influences prospects for successful outcomes.Studies to understand mechanisms underlying impact of stressors and stress adaptations (physiological stress reactivity, coping, psychological status) on processes related to drug use onset, escalation and trajectories. Interaction effects of stress, genetic, and contextual factors on drug abuse risk.     And does change in stress adaptations in part mediate intervention effects? If so, do interventions that effectively improve stress adaptations have potential to prevent drug abuse?Expand understanding of drug abuse to addictions, in general, and how each of these addictions might be related to each other and underlying processes.Explore interplay of implicit and explicit processes as determinants of drug misuse.Explore how deviant social networks might impact drug use decisions in real time.Explore the extent to which group identification is associated with drug abuse through reputation based collectives or actual peer group interactions. Intervention Implementation and Evaluation (T2)Integrate discoveries from the basic biological (e.g. neurobiological), psychological (e.g. emotional, behavioral, cognitive, and developmental), social (e.g. social learning, peer network, and communications), and environmental (geographical locations, access) sciences to develop and test innovative preventive interventions that specifically target underlying mechanisms in drug abuse risk. Integrated data sets account for more of the variability in intervention response than the use of one set of variables alone.How can the assessment of environmental-neurobiological relationships contribute to the design of interventions that impact at critical points in the developmental trajectory to alter risk status?  Determine the types of interventions and specific program components that normalize or improve neurodevelopment in ways that lead to desirable outcomes (e.g., reductions in psychopathology, school failure, psychiatric symptoms, drug abuse, etc.).Development and/or application of new-generation designs, technologies and methodologies to identify neural substrates amenable to prevention interventions and to assess change over time.Indicate those critical windows during childhood that may produce the greatest effects for specific types curricula and program components based on developmental appropriatenessWhat are the critical developmental or transition periods for change; e.g., changing patterns of activation in the HPA axis, cortical and subcortical circuits underlying emergent emotional and neurocognitive processes in response to interventions?What are the critical stages of development during which psychosocial stress and other external influences (e.g., peer presence) differentially exert their effects?Develop and evaluate the effects of innovative educational programs targeted to various learning needs of children on neurodevelopmental markers of successful outcomes.Explore a “personalized” approach that focuses upon individual or subgroup level conditions and characteristics that influence level of liability to drug abuse.  The frontier in prevention research is understanding the individual differences in liability to improve prediction and early risk identification. This tact will further lead to interventions with an appropriate level of intensity and quality that specifically target underlying mechanisms that trigger or exacerbate drug abuse liability and thereby maximize efficacies and cost/benefits.  Practice-oriented Phase (T3) Research to test the degree to which efficacy and effectiveness trial outcomes can be replicated under real world settings, focused on adoption, adaptation, and disseminationStudy the characteristics of implementers, organizations, and systems that maximized adoption and maintenance of prevention and cessation programming.Study the types of adaptations that can be made without losing program impacts (e.g., through understanding “active” ingredients of programming)  Scaling Up and Wide-Scale Implementation and Adaption (T4): Increase the public health impact of NIDA research and programsResearch has confirmed the limited extent to which evidence-based interventions have been broadly and effectively implemented and this indicates much progress is needed to achieve population-level impact. A substantial research agenda is needed on the complex processes through which evidence-based interventions are adopted, implemented, and sustained at the community level, with a strong orientation toward devising empirically-driven strategies for increasing their population impact.  This agenda fits with recommendations in the National Prevention Strategy including the dissemination of community-based interventions that address health inequities, especially in inner-city neighborhoods and rural areas, the development, testing, and implementation of effective strategies to engage underserved populations, and the organization of representative, multi-sector community partnerships.Strengthen focus on bi-directional (back and forward across the spectrum, not just T1 to T2) translational researchScience Infrastructure: Enhance the national research infrastructure to support advancements in scienceActively pursue the Institute of Medicine strategy (IOM, 2009) on prevention, which has had a marked impact on prevention science and policy. Develop a large-scale national research program based on the input of a transdisciplinary group of basic and prevention researchers, clinicians, and practitioners. While broad, this can be achieved by assembling a core group of experts from multiple disciplines and institutions to apply a wide range of perspectives and capabilities toward understanding and reducing the drug problem.Develop a strategy to build a strong infrastructure (building both manpower and organizational capacity) to support the dissemination, diffusion and quality implementation of evidence-based prevention practices that range from screening and assessment of vulnerable populations and communities to the appropriate recommendations for prevention programming and monitoring. “Institutionalizing” evidence-based practices in school systems and communities nationwide.Exploring ways in which primary care physicians and pediatricians can assess and attend to children or families exhibiting signs of liability, without stigma or official reporting (except in the presence of imminent harm).Implement comprehensive “menus” of evidence-based programs and services in high poverty neighborhoods, as directed by the community’s assessment of needs.  Programs and policies recommended by experts are well-established and evaluated and could be made available on a large-scale basis.  Some of these programs and policies serve to build self-regulatory skills in individuals that increase resilience against drug-related problems, while others work more universally to shift norms in high risk areas to promote mental and physical health.  On a population-wide level, this strategy would include the establishment of programs for community-level investment (e.g. parks, painting and fixing dilapidated buildings, accessible mental health and academic services, etc.) that inculcates positive work, health and skills.  Ongoing research efforts to apply rigorous evaluation criteria to determine what works best, for whom and why so that programs and policies can be further refined to achieve optimal results for greater numbers.  This strategy would eventually lead to the institutionalization (nationalization) of these programs and policies in communities and schools, particularly those most in need.Create a website and dynamic listserv that enable people and organizations at the state and local levels to communicate and collaborate.  A website that enabled anyone to ask critical questions about prevention and to provide answers to those questions could create a large, “federation” of problem solvers who could exchange information about what is working in ways that would spread knowledge much more quickly than occurs through traditional methods.  Through a new generation of media campaigns, increase public understanding of the need for and consequences of nurturing families and schools.  These newly-designed campaigns should target (appeal to) areas and individual-level characteristics (e.g., sensation-seeking, impulsivity, etc.) that have been shown to be at particular risk for drug abuse.  Also, these ads may disseminate information on evidence-based preventive interventions to familiarize people with new school- and community-based approaches. Rather than messages focusing centrally on drug abuse, they should demonstrate ways in which reducing conflict and coercion in these environments, reinforcing prosocial behavior, and limiting opportunities for experimentation with problem behaviors will prevent substance use and most other problem behaviors. Several decades of ads and a host of other informational campaigns were needed to eventually significantly reduce cigarette smoking; the same strategy is needed here.  To move evidence-based interventions into practice, create opportunities to fund innovative methods grants in the area of implementation/translational science. Create mechanisms and concrete opportunities to translate research findings for policy-makers and the public.Support student and early career training programs in translational drug abuse prevention and intervention.Create opportunities for multiple organizations and institutions to collaboratively conduct cross-cutting, integrative research.Create opportunities for multiple federal agencies to collaborate in funding translational drug abuse prevention and treatment research; e.g., NIH, SAMSHA, ONDCP, OJJDP, etc.Require grantees to demonstrate practice and policy relevance in applications beyond just their obligatory “significance” sections.Unifying themes:Prevention – proactionDevelopmentalContextual TransdisciplinaryTranslational – from T1 to T5, leaving nothing outDisparities, adversity, inequalitySex differencesEarly intervention – starting prior to conception
  • Thank you for the opportunity to comment on your upcoming NIDA 2016-2020 Strategic Plan. We wish to applaud your continued efforts to remain at the cutting edge of research and practice in the field of substance use disorders and treatment.  In particular, we support the following:Basic Neuroscience: Neurobiological  correlates of recovery and drug effects on neuroplasticity.   It is clear that repetitive behaviors and overlearning are a significant cause of the behavioral process of addiction.  Consequently, there is a need to better demonstrate the behavior and cognitive practice that is needed to establish long term recovery.  This is particularly relevant in the context of the recent push to expand opioid assisted treatments.  This expansion leads tothe perception that medication alone is addiction treatment (for example, physician office based buprenorphine without required behavioral treatment).  This is problematic in that medication cannot create the same neuroplastic changes as behavioral practice.Clinical and Translational Science: Accelerating neurobiological recovery.  With the expansion of opioid replacement approaches, there would be an expected delay in the establishment of baseline neurochemistry.   For example, as long as tolerance to external opioids is maintained, one would not expect to see changes in the volume of neurotransmitters or receptors.  With shrinking lengths of stay it is critical to increase the rate of neurobiological recovery, so that treatment gains may be maintained.Public Health: Response to emerging health priorities.  This is a critical area and should be expanded and broken into two key areas: expansion of marijuana and the opioid overdose epidemic.Marijuana: With the rapid movement to legalize marijuana, there has not been adequate time to develop research on the side effects of marijuana, proper dosage and delivery for any medicinal purposes, and development of research on medicinederivatives (Marino! etc.). Research on the effects in states where legalization has already occurred would be helpful to determine the role of legalization, if any, on the rates of addiction. This is particularly important since marijuana has a known role as a gateway drug, particularly if started in youth.Opioids: The opioid overdose epidemic requires immediate investigation to determine causes and tools needed to interrupt the cycle of addiction.  The proposed solutions have disproportionately focused on administrative and medicinal solutions. This is counterintuitive to suggest that we can prescribe our way out of a prescription opiate epidemic with prescription opiates.  The opioid epidemic is exacerbating at the same time the prescription opioid medications are proliferating, increasing availability via diversion and excess prescribing.  Research needs to consider the role of opioid treatments in this problem and solution.  Further, as psychosocial treatments have diminished over time, there has been an increase in rates of addiction and incarceration.Science Infrastructure: Increase the number of well-trained scientists in the addiction field. We agree that there is a need for increased availability of trained scientists with an interest in addictions.  The availability of funding for skilled research is important in the identification of evidence based practices which will yield the best effects.We also notice that there has been a significant change in the types of goals when comparing the prior strategic plan with the current strategic plan.  Specifically, the current strategic plan is almost exclusively medication and biology focused (neuroscience, medications, etc.).  This is in sharp contrast to the prior strategic plan which was primarily focused on behavioral interventions (prevention services, treating comorbid disorders, matching approach to motivation, addressing relapse triggers etc.).  This sharp change suggests the devaluation of psychosocial approaches in the context of a menu of treatment options.  While biologically focused interventions are valuable, it should not be addressed to the exclusion of psychosocial approaches.In this light, we would like to propose the following additional areas of research:Research on Client Medication Matching: Most research has focused on how treatment may be assisted by the addition of certain medications.  More research is needed on client matching criteria.   Specifically, guidance is needed on who is most appropriate for methadone, buprenorphine or naltrexone, as well as who is not appropriate.Prevention Services: Additional guidance is needed on the effective prevention practices, particularly surrounding the use of fear based approaches, which have been proliferating despite research indicating that it is not effective and can increase substance use, especially in youth.  As there are more overdoses, and loved ones who are motivated to help others, it is critical to have clear guidance available so that they can readily access effective evidence based approaches to prevent others from facing addictionResidential Treatment: In recent years there have been serious cuts to the funding, availability and length of stay for licensed residential treatment.  Epidemiological research is needed to examine the decline of availability of licensed residential treatment services as it relates to the increase in the rates of addiction and overdose deaths.  If the level of care that is designated for the most severe substance use disorders is reduced in availability or duration, it should not be surprising that there is an increase in the deaths which are associated with the most severe disorders.Implementation of Parity: Research is needed to examine the implementation of the Mental Health Parity and Addiction Equity Act.  Specifically, what actions are being taken onthe state level and local levels to ensure compliance with the federal law?  A compilation of tools and best practices to support implementation would be very valuable.Implementation of Medicaid Expansion:  Research is needed to examine the effects of the implementation of Medicaid expansion.  This would examine how states with Medicaid  expansion compare with states that do not have Medicaid expansion.  Specifically, it would be valuable to examine treatment availability (number of treatment beds available in each level of care) and length of stay in treatment (well known as the number one predictor of treatment outcome), as compared to overdose rates in states with or without Medicaid expansion.Screening Brief Intervention and Referral to Treatment (SBIRT): In addition to the need for trained scientists, the field is in need of proper tools for the training of physicians to screen and refer to treatment.  Research on the tools, best practices and outcomes for SBIRT would help to make these skills more widely utilized and implemented.  This is particularly important inlight of the increased utilization of prescription drug monitoring programs, which encourage the discussions surrounding substance use and the need for warm handoff to treatment.Workforce Development: The specialty field of substance use disorder treatment faces significant workforce challenges.  Research is needed in how to attract, develop and retain a skilled workforce in the treatment of substance use disorder.  This may include training materials as well as best practice guides containing the tools and procedures to expand the specialty treatment workforce.Again, we thank you for the opportunity to comment on the strategic plan and we are happy to be a part of the dialogue to continue to advance addiction science for the coming years. This work is lifesaving as well as desperately needed for the families for those whose loved ones are struggling with this disease.
  • This document is the Community Anti-Drug Coalitions of America's (CADCA) response to the National Institute on Drug Abuse's (NIDA) request for information regarding the 2016-2020 update oftheir Strategic Plan (RFI NOT-DA-15-005).CADCA has been successfully representing and promoting coalitions, community-based problem solving,and population-level substance abuse prevention efforts since 1992. As a member-based, not-for-profit, CADCA provides coalitions and their communities with support and services relating to all aspects of community-based substance abuse prevention. These services range from training, technical assistance, and the dissemination of best practices and research, (through its National Coalition Institute) to actively promoting and advocating for federal and state policies and practices that increase the effective use of community-based, universal prevention. CADCA currently serves over 5000 coalitions located in the United States and 18 countries around the world.The Draft Strategic Plan included in the RFI is a comprehensive and sound approach to the role thatNIDA should take in substance abuse prevention. Clearly NIDA recognizes the variety of substance abuse priorities across the Institute of Medicine's continuum of care model.CADCA's comments focus on the emphasis that Universal, Selective, and Indicated interventions should play in a comprehensive approach to prevention. CADCA's comments are organized by the Draft Strategic Priorities outlined in the RFI as follows:NIDA Priority: Basic Neuroscience: Improve our understanding of the basic science of drug use, addiction, vulnerability, to addiction, and recovery.NIDA Sub-priority: Increase our knowledge of biological, behavioral, environmental, and developmental factors involved in risk and resilience for drug use and addiction.The effectiveness of universal, selected and indicated interventions in a complete model of prevention is determined to a great extent by the science linking broad environmental conditions to large group, smaller group, and individual behaviors. A complete model of prevention requires a thorough understanding of how macro-level conditions interact with individual level processing as described inthe social-ecology model. While spending on environmentally-based approaches has been decreasing, there is a growing body of research clearly indicating that environmental approaches are highly effective. Environmentally-based approaches delay the initiation of substance use which decreases the likelihood of addiction. Focusing specifically on environmentally-based prevention also yields major economic dividends. The savings per dollar spent on substance abuse prevention can be substantial and range from $2.00 to $20.00 (Swisher, Scherer & Yin, 2004). Miller and Hendrie (2009) indicate that some prevention efforts result in cost-benefit ratios of more than 30:1. Investing in prevention yields savings and reduces economic and healthcare burdens (National Institute on Drug Abuse, 2007). NIDA and NIAAA have invested heavily in prevention science and have focused efforts to understand the factors at the school, family and community levels that make substance more or less likely for a given population. Based on both the significance of Prevention and the decreasing funds available for its implementation, CADCA recommends that a sub-priority be created that is dedicated solely to environmentally-based Prevention. This would help demonstrate and clarify NIDA's long standing commitment in this area.Recommendation: Increase our knowledge of how environmental factors relate to biological, behavioral, and developmental risk and resilience for drug use and addiction.NIDA Sub-priority: Drug effects on neuroplasticity, neural structure, and circuit function across the stages of addiction.Two behavior categories have gained increased significance over the past 5 years relating to this sub­ priority. The first is the growing issue of marijuana exposures. While exposures have increased and have serious consequences for all age groups, these exposures were particularly high for adolescents. According to the Rocky Mountain Poison Center and the American Association of Poison Control Centers, unwanted exposure to marijuana has increased for all age groups. However, the increase from 2006 to 2013 was 95% for adolescents between the ages of 13 and 17. For all age groups in Colorado, marijuana-related exposures increased 89%, while national marijuana-related exposure increased 32% during this same time (Rocky Mountain HIDTA, 2014). Furthermore, increased access to marijuana in certain states is strongly linked to the number of emergency admissions and illnesses. One primary areaof concern for emergency episodes involves edible marijuana. Currently there is a paucity of research on how increased medical emergencies related to marijuana correlates to addiction and how marijuana­ related exposure impacts biochemical and neurological functions (http://www.medicalnewstoday.com/articles/285202.php). Therefore it is important to better understand how second hand exposure as well as various drug ingestion behaviors impact the likelihood of addiction and other negative consequences.CADCA therefore recommends a research priority that specifically addresses both marijuana-related emergencies and marijuana-related exposures.Recommendation: Drug effects of both marijuana-related emergency episodes and marijuana-relatedexposures on neuroplasticity, neural structure, and circuit function  across the stages of addiction.NIDA Sub-Priority: Improve our understanding of the interaction between addiction and co-occurring conditions.Another important research area under this priority involves the impact of electronic nicotine delivery systems (ENDS) on human functions through both direct exposure and indirect exposure. While use of ENDS among youth has tripled from 2011 to 2013 (Bunnell, et al.; 2014), there is little scientific data regarding the impact of its use (Callahan-Lyon, 2014), including its interaction on addiction or co­ occurring conditions.Due to substantial increases in exposure and use of ENDS, combined with the paucity of research in these areas, CADCA recommends that the issue of addiction to co-occurring conditions focus on both marijuana (see above) and e-cigarettes.Recommendation: Improve  our understanding  of the interaction between addiction and co-occurringconditions particularly relating to marijuana and e-cigarettes.NIDA Pri.ority: Clinical and Translational Science: Support the development of new and better interventions and treatments that incorporate the diverse needs of individuals with Substance Abuse Disorders (SUDS).Complex community health problems, like substance use and abuse, require comprehensive,collaborative solutions in order to achieve benefit for the entire community.  "As the field of prevention has matured, it has been recognized that any single strategy is unlikely to succeed and a reinforcing set of strategies has the greatest potential to reduce use" (Johnson et al., 2007, p. 229). Substance use and abuse is influenced at multiple levels and as such interventions must be broad-based, comprehensive and seek change at multiple levels (Sorensen, Emmons, Hunt & Johnston, 1998). NIDA has long supported research on comprehensive, community-based approaches and should continue to do so. While research in the past 5 years has offered much to the field there are still two primary challenges. First, there is still a paucity of community-level, comprehensive approaches that have formally been declared as "best practices". This leads many well-meaning prevention specialists to over-rely on either post diagnosis approaches to substance abuse or indicated and selected approaches to prevention.Research support from NIDA would help solidify the scientific role that universal prevention can play in a population. In addition, research to guide practitioner use of these strategies and how to combine them in ways to achieve maximum benefit for the smallest cost are also needed. Additionally, while there is much focus on single interventions and their impact, more research is needed on the synergy thatoccurs when a comprehensive set of strategies working at multiple levels of influence are implemented. It is also important to support new and innovative approaches to universal prevention that may foster adoption of this approach. Local community members may not fully understand the intricacies of universal prevention, so they may have trouble implementing these approaches with fidelity. Implementing universal intervention strategies without fidelity is detrimental to the prevention movement because lack of fidelity decreases the potential impact of the strategies and may reflect poorly on the field.CADCA recommends that a sub-priority area focus on solidifying the scientific value of promisinguniversal approaches to prevention and increase the likelihood of successful implementation. Recommendation: Support the development of promising, evidence-based, universal prevention strategies, including practices relating to innovative implementation that enhance effectiveness.NIDA Priority: Public Health: Increase the public health impact of NIDA research and programs.Sub-priority: Increase readiness to respond to emerging public health priorities (opioid overdose epidemic, potential consequences of marijuana legalization, changing healthcare landscape, emerging drug trends, etc...)Research demonstrates that coalitions engaging in comprehensive, environmental strategies aresuccessful at bringing about community changes on a variety of issues (Sorensen, G., 1998; National Research Council, 2004; Hingson et al., 2005; Yang, E et al, 2012; Nargiso, J., 2013). Communities with active coalitions engaging in best practices are better prepared for changes in the substance abuse landscape. However, there are two primary challenges to a coalition's success. One is the relative paucity of research on evidence-based best practices for substance abuse prevention coalitionfunctioning. Another is the ability of coalitions to adapt existing best practices. Increasing the number of research projects on effective substance abuse prevention coalition processes would foster the development of best practices that can be integrated into everyday coalition work.Recommendation: Increase readiness to respond to emerging public health priorities by creating aseries of evidence-based best practices for coalition development and capacity. (opioid overdose epidemic, potential consequences of marijuana legalization, changing healthcare landscape, emerging drug trends, etc...)NIDA Sub-priority: Improve the understanding of factors that influence the integration of evidence­ based research findings into healthcare policy and practice.The relationship between substance abuse and other community health issues has long been recognized in the research. Substance abuse has been linked to child abuse, poor school performance, mental  health issues, violence, a range of personal health issues, etc... While these links are generally  understood by health professionals, there is a gap in practices to resolve these issues at the universal prevention level. Leveraging resources through the development of reliable and valid practices for nexus issues would enable coalitions and other groups to more effectively and efficiently manage social health issues at the community-level. There are two primary areas of research that would help coalitions manage these nexus issues. The first involves the best practices for disseminating information regardingthese nexus issues. Improving communication capacity between researchers and practitioners would greatly enhance how theory is implemented in the field. This involves at least some clarification regarding how communities should manage risk factors for nexus issues as opposed to individual issues. The next involves how to leverage resources at the community level to engage the community in developing and maintaining universal prevention for these nexus issues.Recommendation: Improve the understanding and communication of nexus-based risk factors  in order to improve the ability of healthcare professionals  to work with communities towards the full  integration of evidence-based research findings and strategies that result in healthcare policies and practices  that address multiple health issues simultaneously.NIDA Priority: Science Infrastructure: Enhance the national research infrastructure to support advancements in science.NIDA Sub-priority: Improve training for the next generation of scientistsAccording to the Bureau of Labor Statistics, the field of public health is expected to grow more than 20%, and epidemiology is expected to grow 10% over the next eight years( http://www.bls.gov/ooh/community -and-social-service/health-educators.htm#tab  -1).  Community­ based universal prevention has gained recognition as both an effective and efficient element in a complete prevention system (Yang, E et al, 2012). With this recognition is a growing need for researchers who specialize in developing community capacity to engage in universal prevention strategies.Recommendation: Improve training and mentoring opportunities for the next generation of scientists,including those who specialize in community-based, universal prevention.NIDA Sub-priority: Increase effective collaborations in research.Community-based participatory research (CBPR) is a collaborative approach to research that engages community members and researchers as equal partners in all phases of the research process (Israel, Schulz, Parker, & Becker, 1998; Foster-Fishman, 2009). CBPR more appropriately responds to the needs of communities because it engages community members in defining the problem, selecting the solutions, controlling the implementation and owning the knowledge generation process. An understanding of the community context is imperative in solving local problems and the strategies and methods selected by the community are more likely to fit the local context (Foster-Fishman, 2009; Katz, 2004). Additionally CBPR supports Type II Translational Research by making research and action more culturally competent, relevant, and useful (Foster-Fishman, 2009). This approach to research answers questions that fit practitioner needs and takes into consideration more of the factors and conditions in which interventions are implemented in real world setting; hence interventions that come out of CBPR studies are more likely to have buy-in and utility to the community.Recommendation: Increase the use of Community-based participatory  research and evaluation.NIDA Sub-Priority: Increase effective data and resource sharing (big data, biorepositories, transgenic/optogenetic tools, data standards, etc...)Accurate, timely information is the cornerstone of prevention efforts at all population levels, including national, state, county, or local community. Each population level has its own unique challenges and resources and there are three primary priority areas that would greatly enhance current prevention efforts.A complete prevention model requires a variety of approaches to addiction covering the entire spectrum of behavior and motivation. This is true regardless of which holistic prevention model is being used (for example 10M, or Health Pyramid). Within each model are various types of prevention serving different populations ranging from entire populations to individuals. While there is agreement that a complete prevention model addresses the entire spectrum of audiences, there is less agreement as to the appropriate balance of prevention types that are most effective. It is therefore important to better understand how current prevention efforts attempt to find this balance. An assessment of current approaches and levels of prevention will help the field better understand how to achieve an optimal balance of strategies. A monitoring system would delineate which aspects of prevention research are being funded and which areas could use more funding. For example, while research on preventioninterventions is well funded, more monitoring would help ensure that efforts to fund translational research to support practitioner adoption of these interventions occurs.Recommendation: Develop and maintain a prevention  research monitoring system in order to assessstrengths and gaps towards the development of a holistic national model for prevention.Another critical data piece for prevention is the ability of local communities to access local data on emerging trends. In fact, "readiness" described as a priority (see above) is directly related to the availability oftimely information that is presented in a useful format. Not only is local data critical as a tool for responding to emerging trends, it is also critical in tracking the effectiveness of selected strategies. Perhaps the biggest challenge to local coalitions and other local substance abuse efforts isthe availability of local data. While there is a plethora of archival data collected by various federal, state, and county agencies, all too often this data is relatively inaccessible for local communities seeking data directly addressing their smaller, local communities. There is a tendency to aggregate local data sources once it is in the data system or data reporting systems are not capable of disaggregating local data when it exists.Recommendation: Increase effective data and resource sharing applicable to all population  levels,including at the local community level.It is a pleasure and honor for CADCA to offer these recommendations on behalf of more than 5,000 coalitions nationwide. NIDA has always been a powerful force in community drug prevention and CADCA is proud to continue our special relationship with your organization that helps keep communities safer and drug free. We provide the above comments as a way to strengthen our collective understanding of the factors that make substance use and abuse less likely and less severe on a population-wide level in our communities.

Basic Science, Public Health

  • One thing that seemed to be missing from the basic neuroscience priorities (at least explicitly) was mention of development of animal models that more closely mimic the conditions of human drug use. There has been a considerable shift in the last 10 years or so toward "long-access" models of drug self-administration, which likely come closer than "short-access" models to mimicking human use; however, even these models likely fail to capture many important features of human drug use, particularly the adverse consequences of drug use and other factors that drive abstinence (as opposed to extinction). Another thought is that although there is considerable focus on the developmental trajectory of drug use from childhood to adulthood, there is much less known regarding drug use at advanced ages. Granted, this tends to be less of a concern from a population perspective (i.e., drug use is less of a problem at advanced ages compared to adolescence), but it is also likely that drug use in older adults has features and consequences that are distinct, and possibly more deleterious, compared to drug use in younger individuals.
  • Thank you for the opportunity to provide input as NIDA continues efforts to develop a revitalized Strategic Plan for 2016–2020.  As the principal leadership organization for the field of college health, the American College Health Association members include over 800 institutions of higher education and 2,8oo individual college health professionals.  Our members include prevention specialists as well as medical and mental health professionals involved in the prevention and treatment of drug abuse and addiction.  We are pleased to provide input specific to the needs of college populations that may be helpful in NIDA producing an updated plan for the future.We offer the following observations for further consideration as you continue your work:1. We are hopeful that the plan will feature a focus on marijuana use in much the same way that the previous plan focused on prescription drugs. As an emerging public health issue, the legalization of marijuana deserves greater attention given that many states have either legalized or are considering legalization.  As new evidence suggests that there are important effects of even casual marijuana use on young adult neurobiology and psychological well-being, additional research is critically needed.  The plan should incorporate and encourage more scholarly input that informs the decisions of policymakers at state and federal level.2. We would like to see the plan address the need for additional research on the unique vocational rehabilitation needs of college students as part of treatment.  In particular, the last few years have seen the rapid growth of on campus collegiate recovery programs.  Research and evaluation of these programs is important to inform federal, state and institutional policy makers.3. We feel that it is also important to include content within the plan regarding the integration of technology and/or leveraging technological advances to advance treatment, intervention, or prevention initiatives.  Promising evidence is emerging regarding delivery of prevention and treatment via on-line, smart-phone based, and virtually.  These technologies are readily adopted by college student populations and could be more cost effective and accessible than traditional methods. 4. A final observation is that the proposed Strategic Plan appears to give less attention to the realm of public health when compared to neuroscience, translational science, and science infrastructure.  We hope that a more balanced approach can be adopted.  While the neuroscience-based approach entails a focus on individual factors and their role in substance abuse, public health brings an equally valuable focus and consideration of macro-level factors influencing substance use/abuse.We hope this input is useful in your important work, and that it will help produce a well-rounded, relevant, and comprehensive strategic plan that positions NIDA and its stakeholders for the important work that lies ahead.I thank you in advance for your interest in college students’ health and incorporating our insights into the plan development process.  I stand ready to assist in any way possible
  • Legacy appreciates the opportunity to submit comments in response to the Request for Information (RFI) regarding the National Institute on Drug Abuse’s (NIDA) strategic plan for 2016-2020. We were encouraged that the Draft Strategic Priorities listed in the RFI contained a focus on public health. We were particularly pleased to see the emphasis on implementation science and “increasing readiness to respond to emerging public health priorities,” such as recent changes in marijuana legalization and emerging drug trends. Legacy wholeheartedly supports these efforts with regard to tobacco and nicotine products and their association to other drugs of abuse. Legacy appreciates NIDA’s emphasis on developing the next generation of scientists – a goal we share at Legacy as well.Legacy envisions an America where tobacco is a thing of the past, where all youth and young adults reject tobacco use.  Legacy’s proven- effective and nationally recognized public education programsinclude truth®, the national youth smoking prevention campaign that has been cited as contributing to significant declines in youth  smoking; EX®, an innovative public health program designed to speak to smokers in their own language and change the way they approach quitting; and research initiatives exploring the causes, consequences and approaches to reducing tobacco use. Located in Washington, D.C., the foundation was created as a result of the November 1998 Master Settlement Agreement (MSA) reached between attorneys general from 46 states, five U.S. territories and the tobacco industry.We understand that our partner organization, the Campaign for Tobacco Free Kids, has submitted comments to this RFI, and we fully support those comments and incorporate them by reference here. As was noted in those comments, tobacco use continues to be the number one cause of preventable death and disease1 and more needsto be done to end this epidemic. Legacy, through its research and programs, focuses its work on several critical populations that bear the brunt of tobacco’s toll.  Smoking rates among minorities, the LGBT population, those with low education and low income levels are much higher than that of the general population.2,3   Further, our research on the children of smokers has shown that parental smoking influences their children’s smoking. The research also found that when parents quit smoking, it also influences their children’s behavior – the children of smokers who quit were less likely to smoke or develop into regular smokers.4   To end the tobacco epidemic, more must be done to explore the causes of tobacco use in all these at-risk populations. We encourage NIDA to increase its research on tobacco use, particularly among those groups disproportionately affected by tobacco.Additionally, while strides have been made in reducing some forms of tobacco use, much work needs to be done to reduce not only cigarette use, but also other forms of tobacco use, including cigars of all sizes, smokeless tobacco and emerging products that do not necessarily contain tobacco, but contain tobacco- derived nicotine. In recent years, the use of new and emerging tobacco products, like e-cigarettes, little cigars/cigarillos (LCCs), and hookah has been on the rise among young adults,5-8 despite a modest decline in cigarette use.9 Rising trends in the use of new and emerging tobacco products are of concern, as evidence suggests that some of these products portend similar negative health consequences as regular cigarette smoking.10-12 We encourage NIDA to support research to better understand more about the causes, consequences, and pathways to nicotine addiction as it differs across a variety of tobacco products.Further, Legacy urges NIDA to strengthen its focus on (a) understanding the connection between tobacco, marijuana use, and other addictive substances; (b) exploring the links between drug use and abuse to the use of new and emerging tobacco products (e.g., e-cigarettes, hookah); (c) developing new methods and models to understand the progression from initiation to regular use among youth and young adults; (d) developing and testing novel modalities of assessment and intervention to deter rates of tobacco product use in young people and to help current users quit; and (e) recognizing the complex interplay between tobacco use, drug use, and HIV/AIDS. These issues are outlined below in more detail.Very little research exists with regard to the impact of nicotine exposure on the adolescent brain and subsequent development. Most of what we know about how nicotine effects youth brain development comes from fetal studies or animal studies.1   Because nearly 90% of adult smokers begin smoking during the critical period of adolescent brain development,1 more research is needed to determine nicotine’s role in this phenomenon.  Some questions that warrant further exploration include: Are adolescents and young adults more susceptible to nicotine addiction relative to older adults? What is the threshold of nicotine exposure at which youth and young adults become addicted to nicotine? Does the threshold for nicotine addiction differ across tobacco products?  Legacy strongly encourages NIDA efforts to find the answers to these questions.This is important not just for nicotine addiction and could have implications that touch many areas of NIDA’s work. Our own work at Legacy, and that of others, indicates that tobacco use, including the use of new and emerging tobacco products, is highly correlated with alcohol and marijuana use.13-16 Animal research studies have found connections between nicotine addiction and addictions to other substances, some of which indicate a causal sequence of tobacco use leading to other drugs of abuse.17,18 The potential influence of marijuana use on tobacco use  is particularly noteworthy given recent state-level changes in the legalization of marijuana. It is unclear how marijuana and other drugs of abuse are differentially related to the spectrumof new and emerging tobacco products (LCCs, hookah, e-cigarettes), but preliminary findings from Legacy indicate that marijuana use was significantly associated with use of these products in a national sample of young adults (study under review). Further, cigars (and use of cigar wrappers in particular), which remain unregulated by the FDA, are associated with marijuana use.20-23   Thus, while we know about usage patterns from epidemiological studies, more research is needed to understand the interaction in the brain between nicotine, marijuana, and other substances. Legacy is encouraged by NIDA’s interest in links between tobacco use and marijuana use as a priority topic and encourages NIDA to allocate more of its budget to this area.Legacy supports NIDA’s focus on HIV/AIDS in the 2016-2020 strategic plan and we want to highlight the complex interplay between tobacco use, drug use, and HIV/AIDS as an important area for research. While a main focus of HIV prevention has been on harm reduction related to injection drug use, current smoking is also associated with increased all-cause mortality compared to non-smoking in persons living with HIV/AIDS.24 As treatment improves and HIV is managed as a chronic disease25,26, there is an increasing need to understand and tailor tobacco prevention and treatment services to those with HIV and those at greatest risk for HIV.27-29Finally, Legacy applauds NIDA’s work with the Food and Drug Administration (FDA) in its tobacco regulatory science program. While that work is absolutely critical to improving cessation rates among current smokers and reducing the overall morbidity and mortality associated with nicotine addiction, we encourage NIDA to devote funds to studies that seek to translate research into policy and practice.  For example, the FDA Center for Tobacco Products has indicated that setting tobacco standards that reduce the appeal and addictiveness of tobacco products is a priority. NIDA’s research into factors that trigger tobacco addiction and make nicotine and tobacco products appealing are critical to achieving this goal.  Funding from FDA alone in this area is not sufficient to develop this line of research and Legacy urges NIDA to continue and expand its research to support tobacco and nicotine regulation.  Similarly, we encourage NIDA to prioritize further exploration of novel modalities of assessing mechanisms that impact tobacco use and nicotine addiction, and developing and pilot testing innovative platforms for deploying targeted prevention and interventions aimed at reducing tobacco use and co-existing substance use conditions. Some work by our investigators indicates that use of non-traditional assessment platforms significantly adds to our understanding of the factors that impact tobacco use and nicotine addiction.30-33 Additionally, our past and ongoing work supports that innovative platforms for delivering prevention and treatment interventions can have broad reach and impact.34-36 More research is needed to develop and test these novel methodologies for assessment and intervention delivery.Legacy appreciates NIDA’s consideration of these recommendations as it develops its strategic plan for 2016-2020. If you have questions or need additional information, please contact [PII Redacted].  We look forward to working with you in implementing the plan in the coming years.ReferencesU.S. Department of Health and Human Services. The health consequences of smoking – 50 years of progress: a report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health,;2014.Agaku IT, King BA, Dube SR. Current cigarette smoking among adults - United States, 2005-2012. MMWR. Morbidity and mortality weekly report. Jan 17 2014;63(2):29-34.Lee JG, Griffin GK, Melvin CL. Tobacco use among sexual minorities in the USA, 1987 to May 2007: a systematic review. Tobacco control. Aug 2009;18(4):275-282.Mays D, Gilman SE, Rende R, Luta G, Tercyak KP, Niaura RS. Parental smoking exposure and adolescent smoking trajectories. Pediatrics. Jun 2014;133(6):983-991.Barnett TE, Smith T, He Y, et al. Evidence of emerging hookah use among university students: a cross-sectionalcomparison between hookah and cigarette use. BMC public health. 2013;13(1):302.Cobb C, Ward KD, Maziak W, Shihadeh AL, Eissenberg T. Waterpipe tobacco smoking: an emerging health crisis in the United States. American journal of health behavior. 2010;34(3):275-285.Smith JR, Edland SD, Novotny TE, et al. Increasing hookah use in California. American journal of public health.Oct 2011;101(10):1876-1879.Richardson A, Williams V, Rath J, Villanti AC, Vallone D. The Next Generation of Users: Prevalence and Longitudinal Patterns of Tobacco Use Among US Young Adults. American journal of public health. 2014;104(8):1429-1436.Agaku IT, King BA, Dube SR. Current cigarette smoking among adults-United States, 2005–2012. MMWR. Morbidity and mortality weekly report. 2014;63(2):29-34.Akl EA, Gaddam S, Gunukula SK, Honeine R, Jaoude PA, Irani J. The effects of waterpipe tobacco smoking onhealth outcomes: a systematic review. Int J Epidemiol. June 2010;39(3):834-857.American Lung Association. An emerging deadly trend: Waterpipe tobacco use. 2007.Nonnemaker J, Rostron B, Hall P, MacMonegle A, Apelberg B. Mortality and Economic Costs From Regular Cigar Use in the United States, 2010. American journal of public health. Jul 17 2014:e1-e6.Villanti A, Cobb C, Cohn AM. Correlates of hookah use and predictors of hookah trial in young adults aged 18 to 24. Am J Prevent Med (2014, accepted for publication).Cohn AM, Cobb C, Richardson A, & Niaura R. The Other Combustible Products: Prevalence and Correlates of Little Cigar/Cigarillo Use among Cigarette Smokers (accepted for publication). Nicotine and Tobacco Research.Cohn AM, Villanti A, Richardson A., Rath J, Williams V, Stanton C, Mermelstein R. The association between alcohol, substance use, and new and emerging tobacco products in a young adult population (revise and resubmit). Addictive Behaviors.Cohn AM, Villanti AC, Rose SW, Pearson JL, Johnson AL, Kirchner TR, Williams VF, Rath JR. Support for marijuana legalization among U.S. young adults: Tobacco use and other risk-related correlates. Abstract submitted to the Society for Research on Nicotine and Tobacco annual meeting, Philadelphia, PA, 2015.Kandel ER, Kandel DB. A Molecular Basis for Nicotine as a Gateway Drug. New England Journal of Medicine.2014;371(10):932-943.Kandel D, Kandel E. The Gateway Hypothesis of substance abuse: developmental, biological and societal perspectives. Acta paediatrica (Oslo, Norway : 1992). Feb 2015;104(2):130-137.Office of National Drug Control Policy, The White House. Marijuana resource center: State laws related to marijuana. 2014; http://www.whitehouse.gov/ondcp/state-laws-related-to-marijuana. Accessed August 20,2014, 2014.Richardson A, Rath J, Ganz O, Xiao H, Vallone D. Primary and dual users of little cigars/cigarillos and largecigars: demographic and tobacco use profiles. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco. Oct 2013;15(10):1729-1736.Delnevo CD, Giovenco DP, Ambrose BK, Corey CG, Conway KP. Preference for flavoured cigar brands among youth, young adults and adults in the USA. Tobacco control. Apr 10 2014.Sifaneck SJ, Johnson BD, Dunlap E. Cigars-for-blunts: choice of tobacco products by blunt smokers. Journal ofethnicity in substance abuse. 2005;4(3-4):23-42.Everett SA, Malarcher AM, Sharp DJ, Husten CG, Giovino GA. Relationship between cigarette, smokeless tobacco, and cigar use, and other health risk behaviors among U.S. high school students. The Journal of school health. Aug 2000;70(6):234-240.Pines H, Koutsky L, Buskin S. Cigarette smoking and mortality among HIV-infected individuals in Seattle, Washington (1996-2008). AIDS and behavior. Jan 2011;15(1):243-251.Siegel K, Lekas HM. AIDS as a chronic illness: psychosocial implications. AIDS (London, England). 2002;16 Suppl 4:S69-76.Vidrine DJ. Cigarette smoking and HIV/AIDS: health implications, smoker characteristics and cessation strategies. AIDS education and prevention : official publication of the International Society for AIDS Education. Jun 2009;21(3 Suppl):3-13.Benard A, Bonnet F, Tessier JF, et al. Tobacco addiction and HIV infection: toward the implementation of cessation programs. ANRS CO3 Aquitaine Cohort. AIDS patient care and STDs. Jul 2007;21(7):458-468.Niaura R, Shadel WG, Morrow K, Tashima K, Flanigan T, Abrams DB. Human immunodeficiency virus infection, AIDS, and smoking cessation: the time is now. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. Sep 2000;31(3):808-812.Reynolds NR. Cigarette smoking and HIV: more evidence for action. AIDS education and prevention : official publication of the International Society for AIDS Education. Jun 2009;21(3 Suppl):106-121.Cohn AM, Cobb C., and Ehlke SJ. Disentangling “the chicken and the egg”: Do risky drinking smokers have stronger implicit motivations to drink or so smoke? Abstract submitted to the 38th annual Research Society on Alcoholism conference; San Antonio, Texas, 2015.Ehlke SJ, Cohn AM, & Cobb C. Self-efficacy to quit smoking and implicit cognitions: Does temptation matter among risky drinkers? Abstract submitted to the 38th annual Research Society on Alcoholism conference; San Antonio, Texas, 2015.Cohn A, Brandon T, Armeli S, Ehlke S, Bowers M. Real-time patterns of smoking and alcohol use: an observational study protocol of risky-drinking smokers. BMJ open. 2015;5(1):e007046.Cohn AM, Cobb C, Hagman BT, Cameron A, Ehlke S, Mitchell JN. Implicit alcohol cognitions in risky drinking nicotine users with and without co-morbid major depressive disorder. Addictive behaviors. Apr 2014;39(4):797-802.Cobb NK, Graham AL. Health behavior interventions in the age of facebook. American journal of preventive medicine. Nov 2012;43(5):571-572.Cobb NK, Jacobs MA, Saul J, Wileyto EP, Graham AL. Diffusion of an evidence-based smoking cessation intervention through Facebook: a randomised controlled trial study protocol. BMJ open. 2014;4(1):e004089.Graham AL, Cobb NK, Papandonatos GD, et al. A randomized trial of Internet and telephone treatment for smoking cessation. Archives of internal medicine. Jan 10 2011;171(1):46-53

Basic Science, Public Health, Infrastructure, Unifying Themes

  • On behalf of the Prevention Science Institute at the University of Oregon, we have some additional comments for consideration in the FY 2016-2020 Strategic Plan for the National Institute on Drug Abuse. Specifically, although we agree with the strategic plans as currently drafted, we advocate for a separate and specific focus on prevention (in addition to the focus on intervention and treatment). In addition,  to fully support NIH’s proposed strategic plan to invest in evidence-based health care prevention interventions, the directors and researchers at the University of Oregon’s Prevention Science Institute recommend the addition of the following priorities:Improve the understanding of biological processes related to substance use, abuse and addiction risk and resilience and reactivity to preventive interventions.Increase research to understand the cost of effective preventive interventions as well as the economic benefits that follow, to facilitate uptake and support for investing in prevention by policymakers and funders. Develop a strategy to build a strong infrastructure to support the dissemination, diffusion and quality implementation of evidence-based prevention practices that range from screening and assessment of vulnerable populations and communities to the appropriate recommendations for prevention programming and monitoring.Create opportunities for multiple federal agencies to collaborate in funding translational drug abuse prevention and treatment research;Increase opportunities for combining data from previous prevention and treatment trials and use innovative methods to integrate and analyze these data.Address the prevention needs of youth and high-risk populations (in addition to continuing a focus on treatment).Understand the implications of the changing drug policy environment (i.e., marijuana legalization at the state level). Understand the developmental and contextual influences across all areas of research. Thank you for consideration of this input.

Clinical and Translational Science, Basic Science, Infrastructure, Public Health

  • The Society for Adolescent Health and Medicine (SAHM) is responding to the Request for Information (RFI) (NOT-DA-15-005) that is seeking public input on research priorities to be included in NIDA’s new Strategic Plan. SAHM is a multidisciplinary organization committed to improving the physical and psychosocial health and well-being of all adolescents through advocacy, clinical care, health promotion, health service delivery, professional development and research. We greatly appreciate the opportunity to provide our perspectives as researchers, practitioners, and advocates for the health of adolescents and young adults.The current draft strategic priorities are overall quite comprehensive and exciting. We hope that the new Strategic Plan will include a special focus on adolescent development and research on adolescents and young adults. We also have several broad suggestions for consideration:Around the need identified to “harness the latest research technologies and apply to the ever- evolving substance abuse landscape,” we would suggest clarifying that there is need for both novel research methods (using ever evolving technologies) as well as development and testing of technology-based interventions to address substance abuse. Finding innovative strategies using technology to connect with hard-to-reach populations, including youth living in vulnerable social contexts, is certainly a key priority area in adolescent health research.Many adolescent health researchers are living in states where medical and recreational marijuana use has been legalized, and we anticipate this legislation to continue to expand in the United States.  We clearly need more science on marijuana pharmacology effects and risks in all of its new forms, and need the scientific community’s support to engage in this research, given the escalating availability, decreased perceived risk in adolescent populations, and new industry promoting the drug. Currently, this is only listed under public health not in the science domains.A third suggestion is to be more explicit about the need to engage more scientists and health providers to be aware of evidence based prevention methods and effects of prolonged drug use in children and adolescents more broadly such that substance use research is more integrated into basic, clinical and public health scientific inquiry. In addition to focusing on producing scientists highly trained in drug abuse research, we also need health providers and community stakeholders who can inform the science and incorporate the translation of science into evidence-based practice. While this stakeholder engagement is evident in the research priorities, it would be beneficial to include developing the capacity of health professionals and community partners as part of the training priorities.We agree that addressing health disparities is best infused in all domains. We would also suggest more specific focus on health disparities research. Currently there are no national efforts to look at why despite having a higher percentage of what are considered risk factors for drug abuse and addiction, African American youth use less drugs and alcohol than other groups. This is not explained by economics.  The concern however is heightened in young adulthood when use spikes in African American young adults and reaches, and sometimes exceeds, national averages. This is at a time when other age-race groups in the US are moving toward lower risk of initiation. Understanding this epidemiology and the trajectories for youth of diverse backgrounds with careful attention to the mechanisms for these disparities should help improve strategies to prevent adolescent drug use and define what new risks emerge for this population in young adulthood that changes their trajectory.Finally, we would recommend a greater emphasis on disseminating what works and strengthening implementation and dissemination science.  A model for this is the Office of Adolescent Health’s Teen Pregnancy Prevention Initiative, where great emphasis has been placed on increasing replication, adaptation, and dissemination of evidence-based interventions along with testing promising practices. While we recognize that this may step into service provision, we believe there is critically important and rigorous science needed to understand implementation and dissemination strategies. Certainly intervention proposals should be attentive to the issues of dissemination and scaling up of these interventions.We greatly appreciate the opportunity to provide our organization’s perspectives on these draft strategic priorities. Please do not hesitate to reach out to us with any further questions or clarifications as the NIDA staff and leadership develop this new Strategic Plan.

Clinical and Translational Science, Infrastructure, Public Health

  • There is an urgent need to reduce the time lag currently observed in scientific inquiry, currently averaging 17 years from intervention development to implementation. More funding for dissemination and implementation methods and trial development would help reduce this lag and bring needed prevention and treatment services to our taxpayers who support NIDA research. As an early career researcher, I am committed to developing quality research, but am aware at the restricted funding. Early career mentored funding that allows researchers to develop their skills and thus more significantly contribute to science should be a priority, especially for under represented groups such as women and people of color. Work that supports the integration of substance abuse and mental health would benefit not only patients, but increasingly burdened service systems and budgets. It is of crucial importance that interventions for substance abuse be delivered in alternative settings that are not necessarily specific to substance abuse and mental health such as primary care, in order to accommodate individuals who have little access to such specialty services, or are hesitant to access alternative services due to stigma. There are many opportunities for such research through the changes to our health system under the implementation of the ACA
  • TREATMENT Investigate the effectiveness, feasibility, and patient and provider acceptability of delivering methadone treatment in office-based settingsThere has been a longstanding interest in mainstreaming addiction treatment by integrating it into primary and other health care settings.[1] Because of the relatively effective maintenance therapies available, opioid addiction is among the most promising substance use problems for such integration. In addition, with the passage of the Drug Addiction Treatment Act of 2000, it became possible for healthcare providers, who undergo special training and credentialing, to prescribe buprenorphine for the treatment of opioid addiction. While the uptake of buprenorphine has been significant for some patient populations, evidence suggests that particular patients, namely low income, non-white patients, are less likely to access buprenorphine than more affluent white patients.[2-5] In addition, although methadone maintenance is both cost-effective and effective at reducing use of other opioids, only about 12% of individuals with opioid dependence receive this treatment.[6] Additional research is needed on how to expand access to opioid treatment.Currently, with a few exceptions, methadone for the treatment of opioid dependence is only available through a highly regulated and widely stigmatized system of Opioid Treatment Programs (OTPs). Initial trials have suggested that methadone, like buprenorphine, can be effectively delivered in office-based settings[7-10] and that, with training, physicians would be willing to prescribe methadone to their patients to treat their opioid dependence.[11] Office- based methadone may help reduce the stigma associate with methadone delivered in OTPs [12] and provide a critical window of intervention to address medical and psychiatric conditions.[13] Despite this preliminary evidence, more research is needed to establish whether or not and how methadone can be effectively delivered in office-based settings, whether or not physicians would be willing to prescribe it, what ancillary supports might be needed, and what barriers exist to delivering methadone in such settings. In addition, research is needed to identify patient preferences for treatment and what factors might contribute to disparities in who does and who does not receive such office-based therapies. This research could help inform legislative changes that would be required for the delivery methadone outside of OTPs.Recommendations:NIDA should fund studies that examine the feasibility and effectiveness of office-based methadone. It should also fund studies on physician and patient preferences, barriers, and supports needed for office-based methadone to be successful. Finally, it should fund studies that examine how office-based programs and other factors might contribute to disparities in who does and who does not receive office-based treatment.ReferencesKrantz MJ, Mehler PS. Treating opioid dependence. Growing implications for primary care.Arch Intern Med, 2004,164(3):277-88.Hansen, H.B., Siegel, C.E., Case, B.G., Bertollo, D.N., DiRocco, D., & Galanter, M. Variation in use of buprenorphine and methadone treatment by racial, ethnic, and income characteristics of residential social areas in New York City. Journal of Behavioral Health Services & Research, 2013. 40(3):367-77.Knudsen, H.K., Ducharme, L.J., & Roman, P.M. Early adoption of buprenorphine in substance abuse treatment centers: data from the private and public sectors. Journal of Substance Abuse Treatment, 2006. 30(4): 363-73.Stanton, A., McLeod, C., Luckey, B., Kissin, W.B., & Sonnefeld, L.J. Expanding Treatment of Opioid Dependence: Initial Physician and Patient Experiences with the Adoption of Buprenorphine. American Society of Addiction Medicine, March 2006. Presentation. http://www.buprenorphine.samhsa.gov/ASAM_06_Final_Results.pdf Baxter, J.D., Clark, R.E., Samnaliev, M., Leung, G.Y., & Hashemi, L. Factors associated with Medicaid patients’ access to buprenorphine treatment. Journal of Substance Abuse Treatment, 2011. 41(1):88-96.Raisch DW, Fye CL, Boardman KD, Sather MR Opioid dependence treatment, including buprenorphine/naloxone. Ann Pharmacother, 2002. Feb;36(2):312-21.King VL, Stoller KB, Hayes M, Umbricht A, Currens M, Kidorf MS, Carter JA, Schwartz R,Brooner RK. A multicenter randomized evaluation of methadone medical maintenance. Drug Alcohol Depend, 2002. 65(2):137-48.Fiellin DA, O'Connor PG, Chawarski M, Pakes JP, Pantalon MV, Schottenfeld RS. Methadone maintenance in primary care: a randomized controlled trial. JAMA, 2001. 286(14):1724-31.Krambeer LL, von McKnelly W Jr, Gabrielli WF Jr, Penick EC Methadone therapy for opioid dependence. Am Fam Physician, 2001. 63(12):2404-10.Weinrich M, Stuart M. Provision of methadone treatment in primary care medical practices: review of the Scottish experience and implications for US policy. JAMA, 2000. 283(10):1343-8.McNeely J, Drucker E, Hartel D, Tuchman E. Office-based methadone prescribing: acceptance by inner-city practitioners in New York. J Urban Health, 2000. 77(1):96-102.Salsitz EA, Joseph H, Frank B, Perez J, Richman BL, Salomon N, Kalin MF, Novick DM. Methadone medical maintenance (MMM): treating chronic opioid dependence in private medical practice--a summary report (1983-1998). Mt Sinai J Med, 2000. 67(5-6):388-97.Krambeer LL, von McKnelly W Jr, Gabrielli WF Jr, Penick EC., Methadone therapy for opioid dependence. Am Fam Physician, 2001. 63(12):2404-10.Investigate the mechanisms of “natural” recovery and treatment outcomes beyond abstinenceMost of the literature about drug cessation has focused on the role of treatment, even though the majority of those with substance use problems never seek or receive treatment.[1] Moreover, the vast majority of research on quitting substance use has been done on samples either drawn from treatment settings or among people who have been in treatment. This large body of literature that has focused on the role of treatment in cessation has obscured the prevalence of natural recovery, even though researchers who have examined “natural recovery” contend that this is not an uncommon phenomenon.[2-5]The overwhelming majority of people who use any substance do so non-problematically. [21,  22] Furthermore, what literature is available indicates that many people who are drug- dependent achieve “remission” from their dependence without any form of treatment at all. In fact, evidence suggests it is the common course of most cases of substance dependence. [23- 35]  Most people who use or become dependent on substances seem to “age-out” – that is, they naturally reduce – and ultimately cease – their use as they grow older.[36]“Natural” recovery refers to changes in substance use without the aid of formal interventions.[6- 13] Until recently, the concept of “natural” recovery was considered taboo,[14] but there is potentially a great deal to be learned from those who are able to reduce or stop using drugs on their own. Because research has been biased by the large body of literature on treatment outcomes and sampling that often draws from treatment settings [15-18], little is known about the motivations or circumstances under which people reduce their drug use or quit using drugs on their own. Nor do we understand how an individual’s context or social environment influences reduction or abstinence from drugs.To date, studies of Vietnam veterans provide one of the major sources of information on natural recovery and the role of the social context.[19-20] During the war, an estimated 43% of U.S. Army male enlistees used narcotics, and 20% became dependent. Nevertheless, 8 to 12 months after returning to the US, only 5% of those who had been drug dependent in Vietnam remained so. These data demonstrate the power of environmental and social context as well as drug availability to alter drug use behaviors.A related problem is that much of the exiting research on cessation has been conducted to evaluate different treatment interventions and, thus, is mostly concerned with abstinence as the primary outcome. However, interim milestones are also important in understanding cessation and in their own right, since reductions in use (even if abstinence is not achieved) result in improved health outcomes. Studies of natural recovery could help illuminate what some of those milestones are and how people achieve them.Recommendations: NIDA should fund researchers to study the phenomena of natural recovery in the population across all substances. We recommend longitudinal cohort studies as well as qualitative studies to surface the underlying motivations and mechanisms for spontaneous remission. Samples for these studies should be drawn from non-treatment settings and include individuals who have never sought treatment.  In addition, we suggest that, in all studies about cessation, NIDA also encourage investigators to consider outcomes beyond abstinence, such as reductions in drug use, improved health outcomes, employment, increases in social support, etc.ReferencesGrella CE, Stein JA. Remission from substance dependence: differences between individuals in a general population longitudinal survey who do and do not seek help. Drug Alcohol Depend. 2013 Nov 1;133(1):146-53.Graeven DB, Graeven KA. Treated and untreated addicts: Factors associated with participation in treatment and cessation of heroin use. J Drug Issues 1983; 13(2):207- 218.Klingemann HK. The motivation for change from problem alcohol and heroin use. Br J Addict 1991; 86:727-744.Price RK, Risk NK, Spitznagel EL. Remission from drug abuse over a 25-year period: patterns of remission and treatment use. Am J Public Health 2001; 91(7):1107-1113.Hubbard RL, Craddock SG, Anderson J. Overview of 5-year follow up outcomes in the drug abuse treatment outcome studies (DATOS). J Subst Abuse Treat 2003; 25(3):125- 134.Klingemann HK, Sobell LC. Introduction: natural recovery research across substance use. Subst Use Misuse 2001; 36(11):1409-1416.Preble E, Casey JJ. Taking care of business: The heroin user's life on the streets. Int J Addict 1969; 4:1-24.Chiauzzi EJ, Liljegren S. Taboo topics in addiction treatment. An empirical review of clinical folklore. J Subst Abuse Treat 1993; 10(3):303-316.Granfield R, Cloud W. Social context and "natural recovery": the role of social capital in the resolution of drug-associated problems. Subst Use Misuse 2001; 36(11):1543-1570.Rumpf HJ, Bischof G, Hapke U, Meyer C, John U. Studies on natural recovery from alcohol dependence: sample selection bias by media solicitation? Addiction 2000; 95(5):765-775.Sobell LC, Ellingstad TP, Sobell MB. Natural recovery from alcohol and drug problems: methodological review of the research with suggestions for future directions. Addiction 2000; 95(5):749-764.Edwards G. Natural recovery is the only recovery. Addiction 2000; 95(5):747.Burman S. The challenge of sobriety: natural recovery without treatment and self-help groups. J Subst Abuse 1997; 9:41-61.:41-61.Chiauzzi EJ, Liljegren S. Taboo topics in addiction treatment. An empirical review of clinical folklore. J Subst Abuse Treat 1993; 10(3):303-316.Graeven DB, Graeven KA. Treated and untreated addicts: Factors associated with participation in treatment and cessation of heroin use. J Drug Issues 1983; 13(2):207- 218.Klingemann HK. The motivation for change from problem alcohol and heroin use. Br J Addict 1991; 86:727-744.Price RK, Risk NK, Spitznagel EL. Remission from drug abuse over a 25-year period: patterns of remission and treatment use. Am J Public Health 2001; 91(7):1107-1113.Hubbard RL, Craddock SG, Anderson J. Overview of 5-year followup outcomes in the drug abuse treatment outcome studies (DATOS). J Subst Abuse Treat 2003; 25(3):125- 134.Robins LN. A Follow-up of Vietnam Drug Users. Series A, No. 1. 1973. Washington, D.C., Executive Office of the President. Special Action Office Monograph.Robins LN. The Vietnam Drug User Returns. Series A, No. 2. 1974. Washington, D.C.,U.S. Government Printing Office. Special Action Office Monograph.WHO, U., Principles of drug dependence treatment. Geneva: WHO, 2008.Esser, M.B., et al., Prevalence of Alcohol Dependence Among US Adult Drinkers, 2009- 2011. Preventing Chronic Disease, 2014. 11: p. E206.Grella, C.E. and J.A. Stein, Remission from substance dependence: differences between individuals in a general population longitudinal survey who do and do not seek help. Drug Alcohol Depend, 2013. 133(1): p. 146-53.Slutske, W.S., Why is natural recovery so common for addictive disorders? Addiction, 2010. 105(9): p. 1520-1521.Carballo, J.L., et al., Natural recovery from alcohol and drug problems: A methodological review of the literature from 1999 through 2005, in Promoting self-change from addictive behaviors. 2007, Springer. p. 87-101.Williams, C.R. and B.A. Arrigo, Drug-taking behavior, compulsory treatment, and desistance: Implications of self-organization and natural recovery for policy and practice. Journal of Offender Rehabilitation, 2007. 46(1-2): p. 57-80.Klingemann, H.K.-H., Natural recovery from alcohol problems. The essential handbook of treatment and prevention of alcohol problems, 2004: p. 161.Granfield, R. and W. Cloud, Social context and “natural recovery”: The role of social capital in the resolution of drug-associated problems. Substance use & misuse, 2001. 36(11): p. 1543-1570.Klingemann, H.K.-H. and L.C. Sobell, Introduction: natural recovery research across substance use. Substance Use & Misuse, 2001. 36(11): p. 1409-1416.Cloud, W. and R. Granfield, Natural recovery from substance dependency: Lessons for treatment providers. Journal of Social Work Practice in the Addictions, 2001. 1(1): p. 83- 104.Sobell, L.C., T.P. Ellingstad, and M.B. Sobell, Natural recovery from alcohol and drug problems: Methodological review of the research with suggestions for future directions. Addiction, 2000. 95(5): p. 749-764.Edwards, G., Editorial note: natural recovery is the only recovery. Addiction, 2000. 95(5): p. 747-747.Toneatto, T., et al., Natural recovery from cocaine dependence. Psychology of Addictive Behaviors, 1999. 13(4): p. 259.Burman, S., The challenge of sobriety: natural recovery without treatment and self-help groups. Journal of substance abuse, 1997. 9: p. 41-61.Waldorf, D. and P. Biernacki, The natural recovery from opiate addiction: Some preliminary findings. Journal of Drug Issues, 1981. 11(1): p. 61-76.Lopez-Quintero, C., et al., Probability and predictors of remission from life-time nicotine, alcohol, cannabis or cocaine dependence: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Addiction, 2011. 106(3): p. 657-69.Investigate Heroin-Assisted Treatment and Other Novel Opioid Substitution TherapiesMedication-assisted treatment models for opioid dependence using diacetylmorphine (heroin) have been safely and successfully implemented in several countries, and are now well supported in the academic literature as one tool in an effective, health-based response to problematic drug use, especially among those who have not responded to conventional treatments. Often called heroin-assisted treatment (HAT), such models have proven enormously successful and now operate in Switzerland,[1, 2] Netherlands,[3] United Kingdom,[4] Germany,[5-7] Spain,[8, 9] Denmark,[2] Belgium,[10] Canada,[11] and Luxembourg. HAT allows for the provision of pharmacological grade heroin (diacetylmorphine) to select heroin-dependent people who have not previously responded to other forms of treatment. Typically, patients receive injectable or inhalable heroin 2-3 times per day from a doctor in a clinic setting under strict controls.Peer-reviewed studies around the world have found that HAT is associated with decreased illicit drug use, crime, overdose fatalities, and risky injecting, as well as improvements in physical and mental health, employment and social relations.[1, 3-6, 8, 11-20]  In contrast, few reports have appeared in the scientific literature demonstrating any harmful consequences of HAT.A Cochrane systematic review of all published studies on heroin-assisted treatment (HAT) found significant reductions in illicit drug use and crime, and improvements in health of participants. It concluded, “Each study found a superior reduction in illicit drug use in the heroin arm ratherthan in the methadone arm…the measures of effect obtained are consistently statistically significant.” [13]  An important article in the New England Journal of Medicine on the success ofthe North American Opioid Medication Initiative (NAOMI) in Canada, which provided heroin byprescription to a select group of people who had not responded to other forms of treatment, reported a two-thirds (67%) reduction in illicit drug use or other illegal activity.[11] Similar reductions in illicit heroin use were reported from HAT trials in the UK (72 percent)[4] and Germany (69 percent).[5]The Canadian HAT trial involved an arm of the study that received another opioid agonist, hydromorphone, instead of heroin; these subjects showed similarly impressive results: approximately two-thirds reduction in use of illicit heroin. [21] A second randomized trial in Canada that was recently completed administered both heroin and hydromorphone.[22]Retention rates in HAT programs dwarf those of convention treatments. [5, 11, 13, 23, 24] Patients express a strong preference for HAT over methadone or other standard treatments.[25, 26] While HAT has been restricted to those who do not respond to methadone, evidence now shows it is effective even for people with no previous maintenance experience – suggesting it could be scaled up.[27] Many HAT participants freely choose to move on to another form of treatment (like methadone) or to abstinence,[28, 29] while others continue to receive HAT on a long-term basis, with lasting positive results.[23]HAT is not only more effective at reducing illegal heroin (and other drug) use than methadone, [7] but it has also proven to be more cost-effective.[30] HAT participants are much less likely to commit acquisitive crimes and other non-drug offenses. As a result, HAT programs have been shown to decrease crime in areas where they are situated – leading to additional cost savings of the HAT model.[31-35]Recommendations:Researchers, advocates and health officials have expressed interest in studying and implementing HAT in the U.S. but federal laws and policies have stood in the way of this evidence-based method of treatment. NIDA should fund a heroin-assisted treatment trial in the United States. Such a trial could also compare the safety and efficacy of injectable hydromorphone for opioid dependence. If results are favorable, NIDA should urge the U.S. Congress to amend federal law to allow these innovative opioid replacement treatments to be implemented on a pilot basis in the United States without federal interference.ReferencesUchtenhagen, A., Heroin-assisted treatment in Switzerland: a case study in policy change. Addiction, 2010. 105(1): p. 29-37.Uchtenhagen, A.A., Heroin maintenance treatment: From idea to research to practice.Drug and Alcohol Review, 2011. 30(2): p. 130-137.Blanken, P., et al., Heroin-assisted treatment in the Netherlands: History, findings, and international context. European Neuropsychopharmacology, 2010. 20: p. S105-S158.Strang, J., et al., Supervised injectable heroin or injectable methadone versus optimised oral methadone as treatment for chronic heroin addicts in England after persistent failure in orthodox treatment (RIOTT): a randomised trial. The Lancet, 2010. 375(9729): p. 1885-1895.Haasen, C., et al., Heroin-assisted treatment for opioid dependence: randomised controlled trial. Br J Psychiatry, 2007. 191: p. 55-62.Verthein, U., et al., Long-term effects of heroin-assisted treatment in Germany.Addiction, 2008. 103(6): p. 960-6; discussion 967-8.Verthein, U., C. Haasen, and J. Reimer, Switching from methadone to diamorphine: 2- year results of the german heroin-assisted treatment trial. Subst Use Misuse, 2011. 46(8): p. 980-91.Oviedo-Joekes, E., et al., The Andalusian trial on heroin-assisted treatment: a 2 year follow-up. Drug Alcohol Rev, 2010. 29(1): p. 75-80.Perea-Milla, E., et al., Efficacy of prescribed injectable diacetylmorphine in the Andalusian trial: Bayesian analysis of responders and non-responders according to amulti domain outcome index. Trials, 2009. 10: p. 70.Belgian Monitoring Centre for Drugs and Drug Addiction, 2012 National Report (2011 data) to the EMCDDA by the Reitox National Focal Point: Belgium - New Development, Trends and in-depth information on selected issues. 2013, European Monitoring Centre for Drugs and Drug Addiction (EMCDDA): Lisbon.Oviedo-Joekes, E., et al., Diacetylmorphine versus methadone for the treatment of opioid addiction. N Engl J Med, 2009. 361(8): p. 777-86.Blanken, P., et al., Craving and illicit heroin use among patients in heroin-assisted treatment. Drug Alcohol Depend, 2012. 120(1-3): p. 74-80.Ferri, M., M. Davoli, and C.A. Perucci, Heroin maintenance for chronic heroin-dependent individuals. Cochrane Database Syst Rev, 2011(12): p. CD003410.Fischer, B., et al., Heroin-assisted Treatment (HAT) a Decade Later: A Brief Update on Science and Politics. Journal of Urban Health, 2007. 84(4): p. 552-562.Petrushevska, T., Heroin Maintenance Treatment-Are the Further Investigation Needed?Macedonian Journal of Medical Sciences, 2012. 5(4): p. 453-461.Strang, J., T. Groshkova, and N. Metrebian, New Heroin-Assisted Treatment: Recent Evidence and Current Practices of Supervised Injectable Heroin Treatment in Europe and Beyond. 2012, Lisbon: European Monitoring Centre for Drugs and Drug Addiction. 176.Killias, M., M.F. Aebi, and K. Jurist, The impact of heroin prescription on heroin markets in Switzerland. Crime Prevention Studies, 2000. 11: p. 83-100.Nordt, C. and R. Stohler, Incidence of heroin use in Zurich, Switzerland: a treatment case register analysis. The Lancet, 2006. 367(9525): p. 1830-1834.Reuter, P., Can Heroin Maintenance Help Baltimore. Baltimore, MD: Abell Foundation, 2009.Rehm, J., et al., Mortality in heroin-assisted treatment in Switzerland 1994-2000. DrugAlcohol Depend, 2005. 79(2): p. 137-43.Oviedo-Joekes, E., et al., Double-blind injectable hydromorphone versus diacetylmorphine for the treatment of opioid dependence: a pilot study. J Subst Abuse Treat, 2010. 38(4): p. 408-11.Providence Health Care. The Study to Assess Longer-term Opioid Medication Effectiveness (SALOME). Available from: http://www.providencehealthcare.org/salome/index.html.Blanken, P., et al., Outcome of long-term heroin-assisted treatment offered to chronic, treatment-resistant heroin addicts in the Netherlands. Addiction, 2010. 105(2): p. 300-8.Nosyk, B., et al., The effect of motivational status on treatment outcome in the North American Opiate Medication Initiative (NAOMI) study. Drug Alcohol Depend, 2010. 111(1-2): p. 161-5.Bald, L.K., et al., Heroin or Conventional Opioid Maintenance? The Patients' Perspective. J Addict Med, 2013.Marchand, K.I., et al., Client satisfaction among participants in a randomized trialcomparing oral methadone and injectable diacetylmorphine for long-term opioid- dependency. BMC Health Serv Res, 2011. 11: p. 174.Haasen, C., et al., Is heroin-assisted treatment effective for patients with no previous maintenance treatment? Results from a German randomised controlled trial. Eur AddictRes, 2010. 16(3): p. 124-30.Rehm, J., et al., Feasibility, safety, and efficacy of injectable heroin prescription for refractory opioid addicts: a follow-up study. Lancet, 2001. 358(9291): p. 1417-23.Reuter, P., Can Heroin Maintenance Help Baltimore?: What Baltimore Can Learn from the Experience of Other Countries. 2009: Abell Foundation.Nosyk, B., et al., Cost-effectiveness of diacetylmorphine versus methadone for chronicopioid dependence refractory to treatment. CMAJ, 2012. 184(6): p. E317-28.van der Zanden, B.P., et al., Patterns of acquisitive crime during methadone maintenance treatment among patients eligible for heroin assisted treatment. Drug Alcohol Depend, 2007. 86(1): p. 84-90.Killias, M., et al., Effects of Drug Substitution Programs on Offending Among Drug- Addicts: A Systematic Review. 2009.Lobmann, R. and U. Verthein, Explaining the effectiveness of heroin-assisted treatment on crime reductions. Law Hum Behav, 2009. 33(1): p. 83-95.Frick, U., et al., Long-Term Follow-Up of Orally Administered Diacetylmorphine Substitution Treatment. European Addiction Research, 2010. 16(3): p. 131-138.Garcia-Portilla, M.P., et al., Long term outcomes of pharmacological treatments for opioid dependence: does methadone still lead the pack? Br J Clin Pharmacol, 2014. 77(2): p. 272-84.DRUG SCHEDULINGInvestigate the scientific merits of the U.S. drug scheduling systemThe U.S. Controlled Substances Act (CSA) of 1970 created a five-category scheduling system for most legal and illegal drugs (although alcohol and tobacco were notably omitted). Depending on what category a drug is placed in, the drug is either subject to varying degrees of regulation and control – or, in the case of Schedule I drugs, completely prohibited and left to criminals to manufacture and distribute.The CSA divides controlled substances into five schedules originally determined by Congress. The "most dangerous" drugs are listed in Schedule I, defined as including drugs with "a high potential for abuse," "no currently accepted medical use in treatment in the United States," and "a lack of accepted safety for the use of the drug...under medical supervision." Schedule II  drugs also have "a high potential for abuse" and their abuse may lead to "severe psychological or physical dependence," but they have a "currently accepted medical use." Drugs in Schedules III through V have progressively lower potential for abuse, accepted medical uses, and can only cause "limited physical dependence or psychological dependence."Under the CSA, the DEA may initiate proceedings to add, delete or change the schedule of a drug or substance, as may the Department of Health and Human Services (HHS). Additionally, interested parties, including drug manufacturers, medical or pharmacy associations, public interest groups, state or local governments, or individual citizens can petition to add, delete or change the schedule of a drug or substance. When a petition is received by the DEA, they begin their own investigation of the drug. They may begin an investigation of a drug based on information received from state or local law enforcement and regulatory agencies, laboratories  or other sources. Once the DEA initiates an investigation of a drug, it collects relevant data. The DEA then requests that HHS conduct a scientific and medical evaluation and make a recommendation on whether the drug should be controlled or not and where it should be placed in the CSA schedule.HHS in turn seeks information from the Commissioner of the Food and Drug Administration (FDA) – who delegates this task to the FDA’s Controlled Substances Staff (CSS) – as well as evaluations and recommendations from the National Institute on Drug Abuse (NIDA). HHS may also seek input from the scientific and medical community at large. After consulting with FDA, NIDA, and any others, HHS submits to the DEA its medical and scientific evaluation of the drug and a recommendation on whether the drug should be controlled – and if so, in which schedule it should be placed. While HHS's medical and scientific evaluations are binding on the DEA, its scheduling recommendations are not, with one exception: If HHS recommends that a substance not be controlled, then the DEA may not control or schedule it. After receiving the scientific and medical evaluation from HHS, the DEA Administrator will evaluate all the data and make a final decision.While the CSA sets out the means and procedures for scheduling drugs in accordance with science and medicine, the DEA – a law enforcement agency – is ultimately responsible in most cases for making final decisions on how to schedule various drugs. The assignment to the DEA of this decision-making authority has produced some strange results. For instance, while methamphetamine and cocaine are Schedule II drugs making them available for medical use, marijuana is scheduled alongside PCP and heroin as a Schedule I drug, which prohibits any medical use.The DEA has consistently demonstrated that it is incapable of accurately assessing the state of medical and scientific knowledge about drugs and scheduling them appropriately.[1] Final decisions by the DEA on drug scheduling appear to be guided more by politics and the policy priorities of a law enforcement agency than science. The current system for classifying drugs is flawed.The current drug scheduling system fails to comport with scientific evidence about drug pharmacology and psychopharmacology. Schedule I is for drugs that are highly addictive and have no medical value, while the other schedules are for drugs with medical value but varying degrees of safety and dependence risks. There are no categories, however, for drugs that have no medical value but are not highly addictive either. By this measure, some substances listed under Schedule I do not belong there. Nor are there categories for drugs that have not been evaluated for medical value yet. Many emerging drugs, including synthetic cannabinoid compounds, have been placed under Schedule I without due consideration made to potential therapeutic value. [2-4] The current system for classifying drugs is also outdated and structurally cumbersome in ways that impact the ability of the government to nimbly make assessments and adjustments to the schedules that keep pace with evolutions in scientific understanding and emerging issues like synthetic drugs.[5] For instance, marijuana has remained in Schedule I since 1970 despite the emergence of study after peer-reviewed study around the world that have established the medical value of the chemicals in the marijuana plant.Experts and researchers have called for a new scheduling system based on relative harms of drugs.[6-8] For example, a report published in the esteemed Lancet Journal, researchers proposed an alternative method for drug classification in the United Kingdom, which uses a nine-category matrix to assess the harms of a range of licit and illicit drugs. The new classification system recognizes the fact that alcohol and tobacco cause far more individual and social harms than marijuana, LSD, and MDMA, which have less potential for harm relative to other legal and illegal drugs.[9, 10]Recommendations:Four decades ago, Congress created the drug scheduling system that is in place today. The current system relies too heavily on the DEA, a federal law enforcement agency, to make key decisions about how drugs should be classified according to their medical value and potential for abuse. The current system does not adequately conform to new and emerging circumstances or scientific discoveries that have a bearing on how a drug is regulated. NIDA should conduct a comprehensive evaluation of the federal drug scheduling system that examines the process for adding, changing or removing a substance from the schedules, the best way to assess the risks and benefits associated with current and emerging drugs. As part of this evaluation, NIDA should consider alternative scheduling systems based on evidence of harm and whether the current scheduling system should be reformed so that drugs are classified based on their relative risks and associated harms. NIDA should speak to the merit of overhauling the entire federal drug scheduling process to ensure that decisions on whether to criminalize a drug or not, and whether and how to regulate it, are decided by an objective, independent scientific process.ReferencesDrug Policy Alliance and Multidisciplinary Association for Psychedelic Studies, The DEA: Four Decades of Impeding and Rejecting Science. 2014, Drug Policy Alliance.Coulson, C. and J.P. Caulkins, Scheduling of newly emerging drugs: a critical review of decisions over 40 years. Addiction, 2012. 107(4): p. 766-73.Winstock, A.R. and J.D. Ramsey, Legal highs and the challenges for policy makers.Addiction, 2010. 105(10): p. 1685-1687.Kalant, H., Drug classification: science, politics, both or neither? Addiction, 2010.105(7): p. 1146-9.Nutt, D.J., L.A. King, and D.E. Nichols, Effects of Schedule I drug laws on neuroscience research and treatment innovation. Nat Rev Neurosci, 2013.Fischer, B. and P. Kendall, Nutt et al.'s harm scales for drugs--room for improvementbut better policy based on science with limitations than no science at all. Addiction, 2011. 106(11): p. 1891-2; discussion 1896-8.Rolles, S. and F. Measham, Questioning the method and utility of ranking drugharms in drug policy. International Journal of Drug Policy, 2011. 22(4): p. 243-246.Ray, R. and A. Dhawan, DRUG SCHEDULING—SCIENCE AND CULTURAL PERSPECTIVE. Addiction, 2010. 105(7): p. 1151-1153.Nutt, D.J., L.A. King, and L.D. Phillips, Drug harms in the UK: a multicriteria decision analysis. The Lancet, 2010. 376(9752): p. 1558-1565.Nutt, D., et al., Development of a rational scale to assess the harm of drugs of potential misuse. The Lancet, 2007. 369(9566): p. 1047-1053.End the NIDA monopoly on marijuana for research purposesTwenty three states plus the District of Columbia have acknowledged the medical value of marijuana by allowing those with certain medical conditions to use the substance with the recommendation of a licensed physician. While some states, such as California, have recognized the medical value of the marijuana plant for over 15 years, at the Federal level, marijuana remains a schedule I substance. One of the requirements for a substance to be placed in schedule I, is that is has no accepted medical value. The inconsistency of the federal marijuana classification with state level use has prompted numerous petitions to the Department of Health and Human Services over the past four decades asking for an investigation into the evidence for moving marijuana out of the schedule I category. Furthermore, unlike other substances in the schedule I category, the marijuana available for research purposes can be obtained from only one source, the federal government. The federal government, therefore, is put in the position of provider of marijuana for the purposes of researching a medical benefit it denies exists.Peer-reviewed studies [1-14] around the world have established the medical value of the chemicals in the marijuana plant, including THC and CBD, for the treatment of myriad medical conditions and symptoms, including neuropathic pain,[1, 3, 4, 6, 7, 10-13] multiple sclerosis,[1, 14] seizure disorders,[15-17] glaucoma,[18-20] digestive disorders such as Crohn’sDisease,[21-23] nausea and loss of appetite.[24-28] Furthermore, preclinical and limited clinical research suggests that the chemicals in the marijuana plant may also be helpful in treating Alzheimer’s Disease,[29-31] Parkinson’s Disease,[32-36] cancer,[37-47] arthritis,[10, 48, 49] PTSD,[50-54] and severe brain injury [55, 56]. The federal government currently holds a patent on CBD, one of the active chemicals in marijuana, as a neuro-protectant. The medical use of cannabinoids has become an international hotbed of research activity. Yet most labs and research teams are limited to inferior, synthetic versions of cannabinoids, and have their research stifled at the preclinical level due to the federal monopoly on marijuana for research purposes. States that have legalized the adult use of marijuana in the United States are excited to use the revenue from their programs to fund groundbreaking medical research, but they still have to overcome the barriers to obtaining the product for their studies, even in places where marijuana is available at a corner store.In 1999, the Institute of Medicine (IOM) released a report entitled, “Marijuana and Medicine: Assessing the Science Base”.[57] While the IOM suggests that the chemical found in the marijuana plant be developed into standardized formulations apart from the raw plant, they also concluded that, “Advances in cannabinoid science over the past 16 years have given rise to a wealth of new opportunities for the development of medically useful cannabinoid-based drugs. The accumulated data suggest a variety of indications, particularly for pain relief, antiemesis, and appetite stimulation. For patients who suffer simultaneously from severe pain, nausea, and appetite loss, such as those with AIDS or who are undergoing chemotherapy, cannabinoid drugs might offer broad-spectrum relief not found in any other single medication.”[57] In order for these medications that the IOM suggests to be developed, researchers must have access to high-quality raw marijuana material. THC and CBD are only 2 of over 80 cannabinoids found in the marijuana plant.[58] Limiting access to the plant for research purposes delays the discovery and development of medications that utilize these cannabinoids and can unlock the potential treatments for a countless number of conditions for which there is currently no cure, or for which the current treatment is not effective and related to dangerous side effects.The current federal monopoly on marijuana has slowed down the process of developing cannabinoid-based medications considerably. The organization, Multidisciplinary Association for Psychedelic Studies spent 22 years on an effort to obtain marijuana from the federal government for their study of marijuana to treat symptoms of PTSD – 22 years during which thousands of veterans and others might have found relief from their PTSD symptoms had the drug development process not been hindered by the current federal policies on marijuana research.Recommendations:Ideally, the placement of marijuana in the schedule I category would be reviewed as research has shown that marijuana does not fit the definition of a schedule I substance. However, it isimmediately requested that the stipulation that marijuana used for NIH approved research mustcome from the federal supply be removed. After obtaining approval from an IRB and financial support through a research grant, researchers should be able to obtain the marijuana from a third party provider, similar to how research on other schedule I substances, such as MDMA, is conducted. The federal government should do all it can to facilitate the research and development into cannabinoid based medications, and this includes removing the barriers to access for research purposes, and seriously considering moving marijuana out of the schedule I category, as is supported by numerous public health and medical organizations, including most recently the American Academy of Pediatrics.[59]ReferencesGrant, I., et al., Medical marijuana: clearing away the smoke. Open Neurology Journal, 2012. 6: p. 18-25.Ben Amar, M., Cannabinoids in medicine: A review of their therapeutic potential. J Ethnopharmacol, 2006. 105(1-2): p. 1-25.Wilsey, B., et al., Low-dose vaporized cannabis significantly improves neuropathic pain.J Pain, 2013. 14(2): p. 136-48.Wilsey, B., et al., A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain, 2008. 9(6): p. 506-21.Abrams, D.I., et al., Cannabinoid-opioid interaction in chronic pain. 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E694-701.Ellis, R.J., et al., Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology, 2009. 34(3): p. 672-80.Degenhardt, L., et al., Experience of adjunctive cannabis use for chronic non-cancer pain: Findings from the Pain and Opioids IN Treatment (POINT) study. Drug Alcohol Depend, 2014.Corey-Bloom, J., et al., Smoked cannabis for spasticity in multiple sclerosis: a randomized, placebo-controlled trial. Canadian Medical Association Journal, 2012. 184(10): p. 1143-1150.Maa, E. and P. Figi, The case for medical marijuana in epilepsy. Epilepsia, 2014.Szaflarski, J.P. and E.M. Bebin, Cannabis, cannabidiol, and epilepsy—From receptors to clinical response. Epilepsy & Behavior, 2014.Porter, B.E. and C. Jacobson, Report of a parent survey of cannabidiol-enriched cannabis use in pediatric treatment-resistant epilepsy. Epilepsy & Behavior, 2013. 29(3):p. 574-577.Pertwee, R.G., Targeting the endocannabinoid system with cannabinoid receptor agonists: pharmacological strategies and therapeutic possibilities. Philos Trans R Soc Lond B Biol Sci, 2012. 367(1607): p. 3353-63.Yazulla, S., Endocannabinoids in the retina: from marijuana to neuroprotection. Prog Retin Eye Res, 2008. 27(5): p. 501-26.Kogan, N.M. and R. Mechoulam, Cannabinoids in health and disease. Dialogues Clin Neurosci, 2007. 9(4): p. 413-30.Schicho, R. and M. Storr, Cannabis finds its way into treatment of Crohn's disease.Pharmacology, 2014. 93(1-2): p. 1-3.Naftali, T., et al., Cannabis Induces a Clinical Response in Patients with Crohn’s Disease: a Prospective Placebo-Controlled Study. Clinical Gastroenterology and Hepatology, 2013. 11(10): p. 1276-1280 e1.Alhouayek, M. and G.G. Muccioli, The endocannabinoid system in inflammatory bowel diseases: from pathophysiology to therapeutic opportunity. Trends Mol Med, 2012. 18(10): p. 615-25.Sharkey, K.A., N.A. Darmani, and L.A. Parker, Regulation of nausea and vomiting by cannabinoids and the endocannabinoid system. European journal of pharmacology, 2014. 722: p. 134-146.Borgelt, L.M., et al., The pharmacologic and clinical effects of medical cannabis.Pharmacotherapy, 2013. 33(2): p. 195-209.Todaro, B., Cannabinoids in the treatment of chemotherapy-induced nausea and vomiting. Journal of the National Comprehensive Cancer Network, 2012. 10(4): p. 487- 492.Parker, L.A., E.M. Rock, and C.L. Limebeer, Regulation of nausea and vomiting by cannabinoids. British Journal of Pharmacology, 2011. 163(7): p. 1411-1422.Izzo, A.A. and K.A. Sharkey, Cannabinoids and the gut: new developments and emerging concepts. Pharmacol Ther, 2010. 126(1): p. 21-38.Cao, C., et al., The Potential Therapeutic Effects of THC on Alzheimer's Disease. J Alzheimers Dis, 2014.Martin-Moreno, A.M., et al., Cannabidiol and other cannabinoids reduce microglial activation in vitro and in vivo: relevance to Alzheimer's disease. Mol Pharmacol, 2011.79(6): p. 964-73.Mulder, J., et al., Molecular reorganization of endocannabinoid signalling in Alzheimer's disease. Brain, 2011. 134(Pt 4): p. 1041-60.Chagas, M.H., et al., Effects of cannabidiol in the treatment of patients with Parkinson's disease: An exploratory double-blind trial. J Psychopharmacol, 2014.Lotan, I., et al., Cannabis (medical marijuana) treatment for motor and non-motor symptoms of Parkinson disease: an open-label observational study. Clin Neuropharmacol, 2014. 37(2): p. 41-4.Chagas, M.H., et al., Cannabidiol can improve complex sleep-related behaviours associated with rapid eye movement sleep behaviour disorder in Parkinson's diseasepatients: a case series. J Clin Pharm Ther, 2014. 39(5): p. 564-6.García, C., et al., Symptom-relieving and neuroprotective effects of the phytocannabinoid Δ9-THCV in animal models of Parkinson's disease. British Journal of Pharmacology, 2011. 163(7): p. 1495-1506.Zuardi, A.W., et al., Cannabidiol for the treatment of psychosis in Parkinson's disease. J Psychopharmacol, 2009. 23(8): p. 979-83.Chakravarti, B., J. Ravi, and R.K. Ganju, Cannabinoids as therapeutic agents in cancer: current status and future implications. Oncotarget, 2014. 5(15): p. 5852.Pacher, P., Towards the use of non-psychoactive cannabinoids for prostate cancer. Br J Pharmacol, 2013. 168(1): p. 76-8.Pisanti, S., et al., The endocannabinoid signaling system in cancer. Trends Pharmacol Sci, 2013. 34(5): p. 273-82.Bar-Sela, G., et al., The medical necessity for medicinal cannabis: prospective, observational study evaluating the treatment in cancer patients on supportive or palliative care. Evidence-Based Complementary and Alternative Medicine, 2013. 2013.Brown, I., et al., Cannabinoids and omega-3/6 endocannabinoids as cell death and anticancer modulators. Prog Lipid Res, 2013. 52(1): p. 80-109.Velasco, G., C. Sánchez, and M. Guzmán, Towards the use of cannabinoids as antitumour agents. Nature Reviews Cancer, 2012. 12(6): p. 436-444.Salazar, M., et al., Cannabinoid action induces autophagy-mediated cell death through stimulation of ER stress in human glioma cells. The Journal of Clinical Investigation, 2009. 119(5): p. 1359-1372.Fernández-Ruiz, J., et al., Prospects for cannabinoid therapies in basal ganglia disorders. British Journal of Pharmacology, 2011. 163(7): p. 1365-1378.Guzman, M., Cannabinoids: potential anticancer agents. Nat Rev Cancer, 2003. 3(10): p. 745-55.Singer, E., et al., Reactive oxygen species-mediated therapeutic response and resistance in glioblastoma. Cell Death Dis, 2015. 6: p. e1601.Orellana-Serradell, O., et al., Proapoptotic effect of endocannabinoids in prostate cancer cells. Oncol Rep, 2015.La Porta, C., et al., Involvement of the endocannabinoid system in osteoarthritis pain.European Journal of Neuroscience, 2014. 39(3): p. 485-500.McDougall, J.J., Cannabinoids and Pain Control in the Periphery. 2009. p. 325-345.Roitman, P., et al., Preliminary, Open-Label, Pilot Study of Add-On Oral Δ9- Tetrahydrocannabinol in Chronic Post-Traumatic Stress Disorder. Clinical drug investigation, 2014. 34(8): p. 587-591.Neumeister, A., et al., Elevated brain cannabinoid CB receptor availability in post- traumatic stress disorder: a positron emission tomography study. Mol Psychiatry, 2013.Neumeister, A., The endocannabinoid system provides an avenue for evidence-based treatment development for PTSD. Depress Anxiety, 2013. 30(2): p. 93-6.Passie, T., et al., Mitigation of post-traumatic stress symptoms by Cannabis resin: A review of the clinical and neurobiological evidence. Drug Testing and Analysis, 2012.4(7-8): p. 649-659.Fraser, G.A., The Use of a Synthetic Cannabinoid in the Management of Treatment- Resistant Nightmares in Posttraumatic Stress Disorder (PTSD). CNS Neuroscience & Therapeutics, 2009. 15(1): p. 84-88.Johnson, B.N., et al., Augmented Inhibition from Cannabinoid-Sensitive Interneurons Diminishes CA1 Output after Traumatic Brain Injury. Front Cell Neurosci, 2014. 8: p. 435.Zhang, J., et al., Inhibition of monoacylglycerol lipase prevents chronic traumatic encephalopathy-like neuropathology in a mouse model of repetitive mild closed headinjury. J Cereb Blood Flow Metab, 2014.Joy, J.E., S.J. Watson, and J.A. Benson, Marijuana and medicine: assessing the science base. 1999, Washington, DC: Institute of Medicine, National Academies Press.El-Alfy, A.T., et al., Antidepressant-like effect of delta9-tetrahydrocannabinol and othercannabinoids isolated from Cannabis sativa L. Pharmacol Biochem Behav, 2010. 95(4): p. 434-42.Ammerman, S., et al., The Impact of Marijuana Policies on Youth: Clinical, Research,and Legal Update. Pediatrics, 2015. HARM REDUCTIONAddress the treatment and prevention needs related to common co-morbidities including HIV/AIDS and hepatitis C by researching supervised injection facilities –Supervised injection facilities (SIFs) are controlled health care settings where people can more safely inject drugs under clinical supervision and receive health care, counseling and referrals to health and social services, including drug treatment. They have shown promise in preventing  the transmission of blood-borne diseases such as HIV and hepatitis C and are also effective at reaching people who are currently out of care and linking them to treatment, both for drug dependence and for HIV and hepatitis C. SIFs can play a unique and vital role as part of a  larger public health and treatment approach to drug policy. SIFs are intended to complement – not replace – existing prevention, harm reduction and treatment interventions. This intervention deserves serious consideration and research.SIFs – also called safer injection sites, drug consumption rooms and supervised injecting centers – are legally sanctioned facilities designed to reduce the health and public order issues often associated with public injection by providing a space for people to inject pre-obtained drugs in a hygienic environment with access to sterile injecting equipment and under the supervision of trained medical staff. [1, 2]There are at least 98 SIFs operating in 66 cities around the world in ten countries (Switzerland, Germany, the Netherlands, Norway, Luxembourg, Spain, Denmark, Greece, Australia and Canada) – but none in the United States. [1-5]Numerous evidence-based, peer-reviewed studies from those countries have demonstrated the positive impacts of SIFs.[1-4, 6-32]These benefits include:Increased uptake into treatment for drug dependence, especially among people who are unlikely to seek treatment on their own.[22, 23, 27]Reduced public disorder, reduced public injecting, and increased public safety.[[6, 20, 21, 31, 33]Attracting and retaining a high risk population of people who inject drugs, who are at heightened risk for infectious disease and overdose. [8, 9, 28, 29, 34-36]Reducing HIV and Hepatitis C risk behavior (i.e. syringe sharing, unsafe sex)[3, 6, 8, 9, 11, 19-21, 26, 37, 38]Reducing the prevalence and harms of bacterial infections.[2, 3, 6]Successfully managing hundreds of overdoses and reducing drug-related overdose death rates. [2, 10, 25, 39-41]Cost savings resulting from reduced disease, overdose deaths, and need for emergency medical services. [12, 13, 16, 42]Providing safer injection education, and a subsequent increase in safer injectingpractices.[21, 43]Not increasing community drug use.[2, 3, 24]Not increasing initiation into injection drug use.[18]Not increasing drug-related crime.[6]Increased delivery of medical and social services.[6, 7] [22, 44, 45]There is an extensive body of research studying Insite in Vancouver, British Columbia, with more than two dozen peer-reviewed articles now published examining its effects on a range of variables, from retention to treatment referrals to cost-effectiveness.[3, 9] These reports are in line with reviews of the Australian [4, 33, 46] and European SIFs [5], which show that these facilities have been successful in attracting at-risk populations, are associated with less risky injection behavior, fewer overdose deaths, increased client enrollment in drug dependence treatment services, and reduced nuisances associated with public injection. For example, one recent study found a 30 percent increase in the use of detoxification services among InSite clients. NIDA-funded research could review those potential outcomes in the context of US health care provision and funding.InSite has proved to be cost-effective in terms of overdose and blood borne disease prevented as well. One cost-benefit analysis of InSite estimates that the facility prevents 35 new cases of HIV each year, providing a societal benefit of more than $6 million per year after accounting for the costs of the program.  A recent study published in the prestigious journal The Lancet found that the fatal overdose rate in the immediate vicinity of InSite decreased by 35 percent since it began operating in 2003, while the rest of the city experienced a much smaller reduction of 9 percent.[2, 3, 6]SIFs are worth researching and evaluating as a component of a comprehensive public health approach to reducing the harms of drug dependence, especially the co-morbidities of HIV and hepatitis C. The pilot implementation of a legal supervised injection facility staffed with medical professionals to reduce overdose deaths, increase access to health services, and further expand access to safer injection equipment to prevent the transmission of HIV and hepatitis C is worth investigating in the United States.ReferencesSchatz, E. and M. Nougier, Drug Consumption Rooms: Evidence and Practice. 2012, International Drug Policy Consortium.Semaan, S., et al., Potential role of safer injection facilities in reducing HIV and hepatitis C infections and overdose mortality in the United States. Drug Alcohol Depend, 2011.118(2-3): p. 100-10.Kerr, T., et al., Findings from the Evaluation of Vancouver’s Pilot Medically Supervised Safer Injection Facility—Insite (UHRI Report). Vancouver, BC: BC Centre for Excellence in HIV/AIDS. Addiction and Urban Health Research Initiative, 2009.Maher, L. and A. Salmon, Supervised injecting facilities: how much evidence is enough?Drug Alcohol Rev, 2007. 26(4): p. 351-3.Hedrich, D., T. Kerr, and F. Dubois-Arber, Drug consumption facilities in Europe and beyond. MONOGRAPHS, 2010: p. 305.Potier, C., et al., Supervised injection services: What has been demonstrated? A systematic literature review. Drug Alcohol Depend, 2014. 145C: p. 48-68.McNeil, R., et al., Impact of supervised drug consumption services on access to and engagement with care at a palliative and supportive care facility for people living with HIV/AIDS: a qualitative study. J Int AIDS Soc, 2014. 17: p. 18855.MacArthur, G.J., et al., Interventions to prevent HIV and Hepatitis C in people who inject drugs: A review of reviews to assess evidence of effectiveness. International Journal of Drug Policy, 2013.Boyd, N., Lessons from INSITE, Vancouver's supervised injection facility: 2003-2012.Drugs: education, prevention and policy, 2013. 20(3): p. 234-240.Christian, G., et al., Overdose deaths and Vancouver's supervised injection facility. The Lancet, 2012. 379(9811): p. 117.Pinkerton, S., How many HIV infections are prevented by Vancouver Canada's supervised injection facility? Int J Drug Policy, 2011. 22: p. 179 - 183.Pinkerton, S., Is Vancouver Canada's supervised injection facility cost-saving? Addiction, 2010. 105: p. 1429 - 1436.Andresen, M. and N. Boyd, A cost-benefit and cost-effectiveness analysis of Vancouver's supervised injection facility. Int J Drug Policy, 2010. 21: p. 70 - 76.DeBeck, K., et al., Police and public health partnerships: Evidence from the evaluation of Vancouver's supervised injection facility. Substance Abuse Treatent, Prevention and Policy, 2008. 3(1): p. 1 - 5.Wood, R., et al., Nurse-delivered safer injection education among a cohort of injection drug users: evidence from the evaluation of Vancouver's supervised injection facility. IntJ Drug Policy, 2008. 19(3): p. 183 - 188.Bayoumi, A. and G. Zaric, The cost-effectiveness of Vancouver's supervised injection facility. Can Med Ass J, 2008. 179(11): p. 1143 - 1151.Des Jarlais, D., K. Arasteh, and H. Hagan, Evaluating Vancouver's supervised injection facility: Data and dollars, symbols and ethics. Can Med Assoc J, 2008. 179(11): p. 1105- 1106.Kerr, T., et al., Circumstances of first injection among illicit drug users accessing a medically supervised safer injection facility. Am J Public Health, 2007. 97(7): p. 1228-30.McKnight, I., et al., Factors associated with public injecting among users of Vancouver's supervised injection facility. Am J Drug Alcohol Abuse, 2007. 33(2): p. 319 - 325.Petrar, S., et al., Injection drug users' perceptions regarding use of a medically supervised safer injecting facility. Addict Behav, 2007. 32: p. 1088 - 1093.Stoltz, J., et al., Changes in injecting practices associated with the use of a medically supervised injection facility. J Pub Health (Oxford), 2007. 29(1): p. 35 - 39.Wood, E., et al., Rate of detoxification service use and its impact among a cohort of supervised injection facility users. Addiction, 2007. 102: p. 916 - 919.Wood, E., et al., Service Uptake and Characteristics of Injection Drug Users Utilizing North America’s First Medically Supervised Safer Injecting Facility. American Journal of Public Health, 2006. 96(5): p. 770-773.Kerr, T., et al., Impact of a Medically Supervised Safer Injection Facility on Community Drug Use Patterns: A Before and After Study. Br Med J, 2006. 332: p. 220 - 222.Kerr, T., et al., Drug-related overdoses within a medically supervised safer injection facility. Int J Drug Policy, 2006. 17: p. 436 - 441.Tyndall, M., et al., HIV Sero-prevalence among participants at a supervised injection facility in Vancouver, Canada: implications for prevention, care and treatment. Harm Reduction Journal, 2006. 3(36): p. 1 - 5.Tyndall, M., et al., Attendance, drug use patterns, and referrals made from North America's first supervised injection facility. Drug Alcohol Depend, 2005. 83(3): p. 193 - 198.Wood, E., et al., Prevalence and correlates of hepatitis C among users of North America's first medically supervised safer injection facility. Public Health, 2005. 119(12):p. 1111 - 1115.Wood, E., et al., Do supervised injecting facilities attract higher-risk injection drug users?Am J Prev Med, 2005. 29(2): p. 126 - 130.Small, D., Mental illness, addiction and the supervised injection facility. Visions: BC's Mental Health and Addictions Journal, 2004. 2(1): p. 37 - 39.Wood, E., et al., Changes in public order after the opening of a medically supervised safer injection facility for injection drug users. Can Med Assoc J, 2004. 171(7): p. 731 -734.Fairbairn, N., et al., Women's experiences in North America's First Medically Supervised Safer Injection Facility. Soc Sci Med. 67(8): p. 817 - 823.Salmon, A.M., et al., Five years on: What are the community perceptions of drug-related public amenity following the establishment of the Sydney Medically Supervised InjectingCentre? International Journal of Drug Policy, 2007. 18(1): p. 46-53.Reddon, H., et al., Use of North America’s first medically supervised safer injecting facility among HIV-positive injection drug users. AIDS education and prevention: official publication of the International Society for AIDS Education, 2011. 23(5): p. 412.Hadland, S.E., et al., Use of a Medically Supervised Injection Facility Among Drug- Injecting Street Youth. Journal of Adolescent Health, 2014. 54(2): p. S88-S89.Wood, E., et al., Factors associated with syringe sharing among users of a medically supervised injecting facility. Am J Infect Dis, 2005. 1(1): p. 50 - 54.Kerr, T., et al., Safer injecting facility use and syringe sharing among injection drug users. Lancet, 2005. 366: p. 316 - 318.Kerr, T., et al., The role of safer injection facilities in the response to HIV/AIDS among injection drug users. Current HIV/AIDS Reports, 2007. 4(4): p. 158-164.Kerr, T., et al., A Micro-Environmental Intervention to Reduce Harms Associated with Drug-Related Overdose: Evidence from the Evaluation of Vancouver's Safer Injection Facility. Int J Drug Policy, 2007. 18: p. 37 - 45.Marshall, B.D., et al., Reduction in overdose mortality after the opening of North America's first medically supervised safer injecting facility: a retrospective population- based study. The Lancet, 2011. 377(9775): p. 1429-1437.Milloy, M.-J., et al., Non-fatal overdose among a cohort of active injection drug users recruited from a supervised injection facility. The American journal of drug and alcoholabuse, 2008. 34(4): p. 499-509.Jozaghi, E., A. Reid, and M. Andresen, A cost-benefit/cost-effectiveness analysis of proposed supervised injection facilities in Montreal, Canada. Substance Abuse Treatment, Prevention, and Policy, 2013. 8(1): p. 25.Wood, E., et al., Safer injecting education for HIV prevention within a medically supervised safer injecting facility. Int J Drug Policy, 2005. 16: p. 281 - 284.Wood, E., et al., Attendance at supervised injecting facilities and use of detoxification services. N Eng J Med, 2006. 354(23): p. 512 - 514.Wood, E., et al., Service uptake and characteristics of injection drug users utilizing North America's first medically supervised safer injection facility. Am J Public Health, 2006. 96(5): p. 770 - 773.Salmon, A.M., et al., The impact of a supervised injecting facility on ambulance call‐outsin Sydney, Australia. Addiction, 2010. 105(4): p. 676-683.Expand NIDA’s research priorities to include risk factors and harm reduction within nightlife and festival settingsA significant portion of drug use, especially among young people, takes place in nightlife and festival settings and yet the quantity of available research does not reflect that.[1-6]The majority of this drug use is non-problematic; that is, does not meet the traditional definitions of dependence or addiction.[5-17]  However it can involve risky use behaviors that can lead to hospitalization and deaths.[18] Given the current popularity of large-scale festivals and events with attendance in the tens of thousands or even hundreds of thousands, we need a better understanding of the demographic makeup of these populations, as well as epidemiological data on the rate and nature of drug-related hospitalizations and deaths.Another trend that is not well understood in the US context is patterns of use and misuse of novel psychoactive substances (NPS), for which only limited prevalence data are collected. [19, 20]  In contrast to many European countries, [21] which have monitored the situation for several years – having seen higher rates of intentional use of NPS (such as with the example of mephedrone) – this issue has more recently emerged in the US. [21-23] It deserves attention since as popular drugs such as cannabis, MDMA and other psychedelics remain illegal and hard to acquire, the iterative copycat versions of these drugs will keep appearing on the scene.[23-25] [26]The escalating speed with which NPS appear as well as the current popularity of large scale music events and festivals make further study of harm reduction responses crucial.  This includes not only deepening evaluations of peer-based drug education efforts, for which support in the research already exists, [2-4, 27, 28] but also looking seriously at the practice of drug testing for adulterants. This practice, also known as “pill testing” or “drug checking” in the European context where it has been in place for many years, can provide a critical tool for people to identify dangerous or unexpected substances in the drugs they intend to consume. [29-33]  Further research is needed to identify how this changes drug-using behavior, as well as to determine which among the technologies available are most practical and effective. Other factors that may contribute to changes in drug using behavior, like the location of drug checking services and their coordination with counseling and connection to treatment services if needed, should be explored.Recommendations:NIDA should fund research aiming to collect epidemiological data on hospitalizations and  deaths related to attendance at US music festivals and other large-scale nightlife venues and events. NIDA should conduct further research on novel psychoactive substance use patterns in the US – including investigation into which substances are being by whom and in what contexts. Finally, NIDA should invest in studies on the efficacy of harm reduction interventions in nightlife environments – particularly regarding the efficacy of recreational “drug-checking” and impact of such practices on drug use behavior.ReferencesVan Havere, T., et al., Drug use and nightlife: more than just dance music. Substance abuse treatment, prevention, and policy, 2011. 6(1): p. 18.Hunt, G., M. Moloney, and K. Evans, Youth, Drugs, and Nightlife: Pleasures, Risks, and Identity. 2010: Routledge.Calafat, A., et al., Recreational nightlife: Risk and protective factors for drug misuseamong young Europeans in recreational environments. Drugs: Education, Prevention, and Policy, 2008. 15(2): p. 189-200.Bolier, L., et al., Alcohol and drug prevention in nightlife settings: a review of experimental studies. Subst Use Misuse, 2011. 46(13): p. 1569-91.Winstock, A., P. Griffiths, and D. Stewart, Drugs and the dance music scene: a survey of current drug use patterns among a sample of dance music enthusiasts in the UK. Drug and alcohol dependence, 2001. 64(1): p. 9-17.Winstock, A., The Global Drug Survey 2014 findings. 2014.Siliquini, R., et al., Recreational drug consumers: Who seeks treatment? European Journal of Public Health, 2005. 15(6): p. 580-586.Sanders, B., Drugs, clubs and young people: Sociological and public health perspectives. 2012: Ashgate Publishing, Ltd.Ramo, D.E., et al., Cocaine use trajectories of club drug-using young adults recruited using time-space sampling. Addict Behav, 2011. 36(12): p. 1292-300.Parks, K.A. and C.L. Kennedy, Club drugs: reasons for and consequences of use.Journal of psychoactive drugs, 2004. 36(3): p. 295-302.Miller, B.A., et al., Assessment of club patrons’ alcohol and drug use: the use of biological markers. American journal of preventive medicine, 2013. 45(5): p. 637-643.Miller, B.A., et al., Group influences on individuals' drinking and other drug use at clubs.J Stud Alcohol Drugs, 2013. 74(2): p. 280-7.Kelly, B.C., J.T. Parsons, and B.E. Wells, Prevalence and predictors of club drug use among club-going young adults in New York City. Journal of Urban Health, 2006. 83(5): p. 884-895.Järvinen, M. and S. Ravn, From recreational to regular drug use: qualitative interviews with young clubbers. Sociology of health & illness, 2011. 33(4): p. 554-569.Grov, C., B.C. Kelly, and J.T. Parsons, Polydrug use among club-going young adults recruited through time-space sampling. Substance use & misuse, 2009. 44(6): p. 848-864.Duff, C., The pleasure in context. Int J Drug Policy, 2008. 19(5): p. 384-92.Anderson, T.L., et al., Variations in clubbers' substance use by individual and scene- level factors. Adicciones, 2009. 21(4): p. 289-308.Ridpath, A., et al., Illnesses and deaths among persons attending an electronic dance- music festival-New York City, 2013. MMWR: Morbidity and mortality weekly report, 2014.63: p. 1195-1198.Substance Abuse and Mental Health Services Administration, Results from the 2013 National Survey on Drug Use and Health. 2014, Substance Abuse and Mental Health Services Administration: Rockville, MD.Johnston, L.D., et al., Monitoring the Future national survey results on drug use: 2014 Overview, Key Findings on Adolescent Drug Use. 2015, Ann Arbor: Institute for Social Research, The University of Michigan.Hughes, B. and P. Griffiths, Regulatory approaches to new psychoactive substances (NPS) in the European Union. Addiction, 2014. 109(10): p. 1591-1593.Spiller, H.A., et al., Clinical experience with and analytical confirmation of "bath salts" and "legal highs" (synthetic cathinones) in the United States. Clin Toxicol (Phila), 2011. 49(6): p. 499-505.Measham, F., et al., Tweaking, bombing, dabbing and stockpiling: the emergence of mephedrone and the perversity of prohibition. Drugs and Alcohol Today, 2010. 10(1): p.14-21.Payer, D., Novel synthetic drugs: A neuroscience perspective, in Club Health. 2013, Drug Policy Alliance: San Francisco.Winstock, A. and C. Wilkins, ‘Legal highs’ The challenge of new psychoactivesubstances. Series on Legislative Reform of Drug Policies, Number Amsterdam: Transnational Institute, 2011.Perrone, D., R.D. Helgesen, and R.G. Fischer, United States drug prohibition and legalhighs: How drug testing may lead cannabis users to Spice. Drugs: Education, Prevention, and Policy, 2012: p. 1-9.Sumnall, H., et al., A choice between fun or health? Relationships between nightlifesubstance use, happiness, and mental well-being. Journal of Substance Use, 2010.15(2): p. 89-104.Whittingham, J.R., et al., Avoiding counterproductive results: an experimental pretest of  a harm reduction intervention on attitude toward party drugs among users and nonusers. Subst Use Misuse, 2009. 44(4): p. 532-47.Winstock, A.R., K. Wolff, and J. Ramsey, Ecstasy pill testing: harm minimization gone too far? Addiction, 2001. 96(8): p. 1139-1148.Hungerbuehler, I., A. Buecheli, and M. Schaub, Drug Checking: A prevention measure for a heterogeneous group with high consumption frequency and polydrug use- evaluation of zurich's drug checking services. Harm reduction journal, 2011. 8(1): p. 16.Camilleri, A.M. and D. Caldicott, Underground pill testing, down under. Forensic Science International, 2005. 151(1): p. 53-58.Murray, R.A., et al., Putting an Ecstasy test kit to the test: harm reduction or harm induction? Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 2003. 23(10): p. 1238-1244.MacCoun, R.J., Testing Drugs Versus Testing for Drug Use: Private Risk Management in the Shadow of Criminal Law. DePaul L. Rev., 2006. 56: p. 507.

Clinical and Translational Science, Public Health

  • 1. Better methods of matching the many quality interventions available to individual cases, so that treatment can be individualized for better outcomes  2. Serious investigation into motivational factors which could be harnessed to bring more people to a place where they would consider appropriate treatment
  • The Society for Research on Nicotine and Tobacco (SRNT) applauds the National Institute on Drug Abuse (NIDA) for revitalizing its Strategic Plan and fully supports the many of identified priorities. In addition to our overall support, SRNT would like to put forward the following general recommendations.In addition to epidemiological and clinical research, basic science research can also focus on policy-oriented items. Thus, the importance of basic science research that provides practical knowledge that can inform policy while not necessarily addressing mechanistic hypotheses should be recognized.Clearly, basic neuroscience is important and deserves major focus. However, the importance of basic science that examines behavioral mechanisms of addiction also needs full consideration.Tobacco use remains the leading cause of preventable death and illness in the United States and thus research supporting treatment development for nicotine dependence and tobacco use disorders and dissemination of findings should be a priority.In addition, greater emphasis should be placed on support for the development of novel, evidence-based targeted prevention and treatment interventions for all substance abuse disorders. SRNT recommends three additional considerations be included as sub- priorities to this goal:Development and dissemination of effective behavioral interventions using novel strategies with wide-potential population reach.Emphasis on research into the development of treatments of substance abuse disorders among high risk populations such as low-SES persons and those with comorbid physical and psychiatric conditions. Substance abuse disorders have a disproportionate impact on these populations.Research on optimizing the timing and duration of interventions for substance abuse disorders in order to improve outcomes.Changes in drug policies (e.g., legalization of marijuana use in some states) and new technologies to administer drugs (e.g., electronic delivery systems) have contributed to a void in understanding of important issues related to substance abuse disorders. Issues that warrant serious consideration include:The effects of poly drug use and additives on abuse liability.The impact of different modes of drug delivery on both drug dependence and health, with a particular emphasis on electronic drug delivery methods.The impact of exposure to one substance or one form of delivery of that substance on subsequent use of other substances or other forms of the same substance.The impact of new polices and technologies on harm reduction.

Clinical and Translational Science, Public Health, Basic Science, Unifying Themes

  • Here are the areas that I believe are important priorities:Not on the list:Novel delivery methods for treating brain disorders: The development of non-invasive routes of delivery of compounds or genes to the CNS should be considered a top priority. Educate the public about addiction and how it is a disease: This is very important as drug addicts do not receive the proper care or support from their families and communities. They are treated as criminals. From the list:Better define the interactions between addiction and pain, including molecular, genetic, behavioral , and neural-circuit-related factors, to guide the development of alternate treatment strategies for pain patients: There is a huge opioid epidemic in the United States and experts believe that this is due to an increase in the prescription of pain medications. Most opiate abusers start using prescription meds in order to combat pain associated with injury or surgery. Therefore it is important to understand the mechanisms involved and to better define the interactions between pain and addiction. Increase readiness to respond to emerging public health priorities (opioid overdose epidemic, potential consequences of marijuana legalization, changing healthcare landscape, emerging drug trends, etc.): Same as above.Promoting research that considers the impact of sex and gender on drug abuse and addiction: More studies are highlighting that there are differences between the genders. Therefore we can not use the same approach and therapies to treat males and females. There needs to be more funding focused on gender differences. Improve our understanding of the interaction between addiction and co-occurring conditions: The number of co-occurring mental health disorders together with addiction issues is very high. We need to better understand how the two are related and what leads to drug use.Support the development of novel, evidence-based, targeted prevention and treatment interventions including social, behavioral, pharmacological, vaccines, and brain stimulation therapies (e.g., transcranial magnetic stimulation, direct current stimulation, etc.)Identify measures other than abstinence that can reliably assess SUD treatment outcomes Identify biomarkers of addiction, resilience, and recovery to enable personalized treatment: Without biomarkers we will not be able to predict how a therapy is working or whether or not it is effective.

Clinical and Translational Science, Public Health, Basic Science, Unifying Themes, Infrastructure

  • The following is a list of priority areas that we feel represent understudied topics and/or knowledge gaps in the field:Evaluate agonist treatments for stimulant and cannabis use disorders - find ways to balance risks and benefitsRe-engineer the pipelines for med development with human laboratory studies and alternative early Phase II clinical trial designsCharacterize the use of electronic cigarettes for treating nicotine use disordersDetermine more effective ways of studying emerging drug problems ("dabbing," Spice, etc.)Examine co-abuse of substances (e.g., nicotine-marijuana, opiates-alcohol, marijuana-alcohol, opiates-benzodiazepines, cocaine-marijuana, etc.) and develop effective ways of treating co-abuseUse imaging techniques to identify treatment responseImprove the understanding of neurobiological and neuroimaging studies by incorporating drug-taking behavior and other abuse liability measures into the research where possibleStrongly support more efforts to promote research that directly examines the impact of sex and gender on drug abuse and addictionIn addition to the above, another important component for consideration is to improve how the Strategic Plan is implemented. The following are suggestions for accomplishing this:Develop procedures for communicating NIDA's interest and disinterest in certain research areas to the scientific communityDevelop a central forum at NIDA for IND's that can be accessed by granteesDevelop a more active interaction between NIDA and the DEA and FDA with regard to drug scheduling.

Clinical and Translational Science, Public Health, Infrastructure

  • The American Society of Addiction Medicine (ASAM) is grateful for this opportunity to comment on the National Institute on Drug Abuse’s (NIDA) 2016 Strategic Plan.  ASAM is hopeful that the following comments regarding the draft 2016 research strategy strengthen what is already a thoughtful and robust agenda for future NIDA research.Clinical and Translational Science PrioritiesWhile the identification of new, evidence-based treatment interventions  is necessary to address the diverse treatment needs of patients suffering with addiction, equally important is the development of practice guidelines and performance measures to encourage widespread adoption of these novel therapies.  Furthermore, standardized methods for assessing quality of care, adherence to treatment and patient outcomes (e.g., urine drug testing) are needed to validate the relationship between evidence-based treatment and patient improvements in health and function.Public Health PrioritiesAddiction remains a highly stigmatized disease, despite the heightened awareness of prescription drug misuse and overdose death.  NIDA, in collaboration with the Surgeon General, the Centers for Disease Control and Prevention and other federal stakeholders, could facilitate the development and dissemination of a broad public education campaign that addresses the common misperceptions, myths and fears related to addiction, treatment and recovery.Science Infrastructure PrioritiesThe vast majority of physicians do not receive any training on addiction in medical school. This results in a physician workforce with little to no knowledge about how to identify and treat patients suffering with addiction.  Research that supports the integration of addiction curriculum into medical school would support efforts to both integrate addiction treatment into primary care and address shortages in the addiction provider workforce.  Moreover, improved education may address the disinclination of many physicians to treat patients with addiction and, thereby, improve patient access to high-quality care.For physicians who do specialize in the treatment of addiction, the paucity of performance measures and practice-based research networks available to test the measures that do exist limits the specialists’ ability to gauge their effectiveness and the value of their medical expertise. ASAM respectfully requests that NIDA support the development of a practice-based research network of addiction physician specialists, in order to improve outcomes measurement and ongoing advancement in the field of addiction medicine.Again, ASAM is grateful for this opportunity to inform NIDA’s next strategic plan.  Our members look forward to continued collaboration with NIDA, to advance the science and practice of addiction treatment.

Clinical and Translational Science, Public Health, Unifying Themes

  • The Association of State and Territorial Health Officials (ASTHO) appreciates the opportunity to submit comments on NIDA’s FY 2016-2020 Strategic Plan. ASTHO commends your efforts to ensure that public health is a key component of the plan and that it addresses a broad range of efforts to prevent and treat drug abuse and addiction and mitigate the impact of their consequences.  We encourage you to consider an approach that assures scientific investigation that also includes recovery.  Background ASTHO is a 501(c) (3) nonprofit membership association serving the state and territorial health officials and the more than 100,000 public health staff that work in the state and territorial agencies. ASTHO tracks, evaluates, and advises members on the impact and formation of health policy that may affect state or territorial health agencies, and provides guidance and technical assistance to its members on improving population health. ASTHO supports its members on a wide range of topics based on their needs, including promoting health equity, integrating public health and clinical medicine, responding to public health emergencies,  reducing the harms associated with substance abuse with a focus on prescription drug misuse, abuse, and diversion and addressing the public health consequences of marijuana legalization. Prescription Drug OverdoseInappropriate prescribing practices and overutilization of opioids can result in serious adverse events and death. Deaths from drug overdose have steadily increased over the past two decades and have become the leading cause of injury and death in the United States. Among people 25- to 64-years-old, drug overdose causes more deaths than motor vehicle traffic crashes. Of the 22,134 deaths relating to prescription drug overdose in 2010, 16,651 (75%) involved opioid analgesics and 6,497 (30%) involved benzodiazepines. ASTHO supports federal, state, and community-based interventions that address prescription drug misuse, abuse, and diversion through a comprehensive framework that includes prevention, Surveillance, enforcement, and treatment and recovery. We recognize that each intervention is necessary but insufficient by itself. Additionally, ASTHO’s extensive work on this issue has generated collaboration across a range of disciplines and fields to support coordinated federal, state, and local efforts that address the prescription drug epidemic. As part of the 2014 ASTHO President’s Challenge to reduce the number of prescription drug deaths and rate of misuse and abuse 15% by 2015 (www.astho.org/rx), states pledged to address each of the areas of the comprehensive framework:· Thirty-two states focused on Prevention.  Key themes addressed prescriber guidelines, education campaigns, school based programs, patient materials, Continuing Medical Education (CME) training both required and voluntary, enhanced drug disposal programs, and overdose prevention and naloxone access. Over the past two years, 25 states have enacted policies to expand access to naloxone through distribution by trained first responders or more broadly through friends and families of potential overdose victims. These laws often provide immunity from liability for those who administer naloxone in good faith. States have also enacted Good Samaritan laws, providing protections for those who seek medical assistance for individuals experiencing an overdose. States also were engaged in understanding how to provide access to care through pharmacies or in offices and utilize health reform and transformation to provide coverage for its use.· Thirty-five states pledged to support improved surveillance and monitoring. Key themes addressed increasing access and use of the Prescription Drug Monitoring Program (PDMP) for public health surveillance, supporting improved update of the usage of PDMP’s, utilizing PDMP’s to target underserved communities and areas of high need through mapping and hot-spotting, utilizing EMS electronic database that capture data on drug overdose and naloxone use by emergency professionals, and assisting in cross cutting surveillance with other drug use and alcohol use in states. States have continued to improve PDMPs by enacting policies to decrease the time that it takes for information to be reported to the database, requiring prescribers to query the database prior to prescribing, and allowing health departments to have access to the database for the purposes of conducting a population level analysis.· Twenty-two states pledged to support and collaborate with enforcement. Key themes included utilizing data for drug trafficking, continuing to support the Opiate Intervention Program within the state’s Medicaid system at the regulatory level, expanding law enforcement resources to increase availability of drug take-back programs, and increasing training for law enforcement and prosecutor groups at national and regional conferences on prescription drug abuse and diversion.·       Twenty-three states pledged to support treatment and recovery efforts in their states. Key themes included promoting SBIRT protocols among hospitals and community providers; supporting the use of community health workers to link patients to services and provide support during recovery; supporting legislation for opioid treatment facilities; increased access to buprenorphine training for prescribers;, examining parity among health insurance plans for coverage; and developing systems of integrated care for individuals with co-occurring mental health and substance abuse issues.Recommendation: States are enacting policies and programs at a rapid rate to counter the prescription drug abuse epidemic.  We encourage NIDA’s to support the evaluation of efforts underway in the states to address prescription opiate abuse.  These evaluation efforts will assist states as they work to enact, implement and enforce evidenced-based policies to protect the health of the public.Legalization of Medical and Recreational MarijuanaPublic opinion is shifting toward favoring decriminalization or explicit legalization of marijuana. As a result, an increasing number of states and territories have enacted laws legalizing the medical and recreational use of marijuana.  The recognized harms and health consequences of marijuana have seemingly been lost in the debate about the legalization. Marijuana continues to be the most commonly used illicit drug in the U.S. with patterns of use trending upward, particularly among young people.  Treatment admissions for marijuana as the primary drug of abuse have tripled over the last 20 years and it is the second leading substance for which people receive drug treatment.State and territorial health agencies are often tasked with regulating their jurisdictions’ medical marijuana program. However, public health agencies also have a role to play in the prevention and mitigation of harms associated with marijuana use.  ASTHO and its members appreciate NIDA’s efforts to research and disseminate findings on the implications of marijuana use, including: the risks of addiction, its role as a gateway drug, the effect on brain development, its relation to mental illness, the effect on school performance and achievement, the risk of motor-vehicle accidents, and the risk of cancer and other health effects. However, more research is needed in these and other areas.Recommendation: State-level marijuana policies are rapidly changing. Little is known about the affect these policies will have on public health outcomes. For example, we need a better understanding of the effects of second-hand cannabis smoke exposure. As the use of marijuana becomes normalized and increases, so likely will the associated harms and health consequences. We will need to be prepared to communicate the evidence of these harms, address misuse and addiction, and expand access to treatment. We encourage that NIDA’s strategic plan have a priority to research the potential consequences of marijuana legalization.  Additional recommendations for your consideration · In the section ”Clinical and Translational Science” :o   We strongly encourage the addition of recovery interventions to the prevention and treatment interventions you have indicated. o   We support your inclusion of “Overdose prevention or reversal” with the recommended addition that this includes research on impact of “rescue drugs” accessible to first responders, family and friends and the general public.  · In the section “Public Health: Increase the public health impact of NIDA research and programso   We applaud this focused section in the plan and inclusion of research on the successful implementation. Additionally we recommend this include research on sustainability and replication of public health interventions.o   We strongly support the section: “Increase readiness to respond to emerging public health priorities (opioid overdose epidemic, potential consequences of marijuana legalization, changing healthcare landscape, emerging drug trends, etc.)” Additionally, as noted above we emphasize the need for a priority focus on research of the potential consequences of marijuana legalization with a special focus on impact on youth.· In the section “Unifying themes” we strongly encourage that these themes are significantly, not just peripherally, included across all areas of the strategic plan.  We encourage you to go beyond research on health disparities and include in the plan health equity with the aim to understand interventions that improve health equity. As described above, ASTHO and our members the state public health officials are engaged and actively supporting the efforts highlighted in NIDA’s strategic plan. We are pleased that public health is considered a key component of your strategy and look forward to working with you to prevent and treat drug abuse and addiction and mitigate the impact of their consequences.

Format, Basic Science, Public Health, Clinical and Translational Science, Unifying Themes, Infrastructure

  • On behalf of the American Psychiatric Association (APA), the medical specialty association representing 36,000 psychiatrists and their patients and families, I am pleased to share APA’s comments on the National Institute on Drug Abuse’s draft strategic plan. We would like to commend NIDA on developing a well-organized draft that is thoughtful, comprehensive, impactful and wide-reaching in its scope. Our feedback on the draft strategic priorities reflects our great concern about the impact of substance use disorders on people in the U.S. and great hope for improvement in the realm of research going forward.APA strongly supports NIDA's mission. Abuse of and addiction to alcohol, nicotine, and illicit and prescription drugs cost Americans more than $700 billion a year in increased health care costs, crime, and lost productivity.1-3 Each  year, illicit and prescription drugs and alcohol contribute to the death of more than 90,000 Americans, while tobacco is linked to an estimated 480,000 deaths per year.4-5 These disorders are diagnosable and treatable, and when not treated are associated with suffering, premature death and diminished quality of life. The presence ofsubstance use disorders can also exacerbate the severity of other medical illnesses, inhibit appropriate medical management, and is associated with increased general medical costs.We particularly appreciate several aspects of NIDA’s current work and its draft strategic plan including in the basic neuroscience domain.  Efforts to gain greater knowledge about the multiplicity of factors for risk and resilience in drug use and addiction and understanding the developmental pathways of addiction and individual heterogeneity are extremely important. NIDA’s awareness of the need to focus on drug use and co- occurring conditions including HIV/AIDs is to be applauded. This priority is consonant with NIDA’s excellent work on comorbidities in relation to mental health, HIV, and the Hepatitis C virus.NIDA’s draft strategic priority centered on the development of novel, evidence-based, targeted prevention and treatment interventions in a variety of domains is essential. In particular, focused development efforts on overdose prevention and reversal hold great promise in the face of the recent epidemic levels of opiate use disorders and mortality due to overdose. The APA agrees with and praises NIDA on its attention to the public health domain and its prioritization of the identification of factors that facilitate the integration  of evidence-based research findings into healthcare policy and practice. In addition, the APA concurs with NIDA about the importance of increasing partnership with a wide variety of stakeholders to advance the dissemination of evidence-based research findings into policy and practice.APA appreciates NIDA drawing attention to the need for acceleration of development and utilization of advanced technologies. In addition, we commend NIDA’s focus on generating higher levels of transparency and reproducibility of research.We wish to acknowledge that NIDA has proposed appropriately that the domains of its draft priorities on drug use be regarded through the multiple lenses of gender, age spectrum and life course, underrepresented and underserved populations, and common comorbidities.NIDA’s draft has stimulated several additional suggestions and recommendations which we respectfully offer for NIDA’s consideration. The highlights of these suggestions span the full range of areas covered in the draft and are summarized as follows:Basic Neuroscience: Encourage research on neurobiological correlates of vulnerability to addictions and the study of treatment targets as a consideration of neurobiological correlates of recovery.Clinical and Translational Science:  Support bidirectional research involving translation  of bench findings to clinical research in humans as well as research on strengthening bedside to bench.  Ensure that functional measures are included along with biomarkers of addiction, resilience and recovery to enable personalized treatment. Support  dissemination of research so that evidence-based practices are applied in the community. Develop evidence-based approaches to substance use disorder interventions in integrated care settings. Increase efforts to develop more efficacious medications for treating addictions. Foster collaborative research involving psychiatry and general medicine given the high morbidity and mortality associated with comorbidity of substance use disorders and medical illnesses. Expand focused development efforts to study population-based strategies for treatment adherence in patients living with substance-related disorders,  HIV, and the hepatitis C virus.Public Health:  Conduct research on cost analysis and economic feasibility of treatments. Engage in greater dissemination of NIDA progress, initiatives, research and education to outlets with strong public health impact including the health media. Undertake initiatives to improve training of clinicians at the front lines of public health, equipping them with tools for clinical implementation to decrease the research-practice gap. Consider pursuing efforts to improve the understanding of how interventions should be tailored to meet the needs of diverse populations: gender, race/ethnicity, sexual orientation, gender identity and limited English proficiency. There is also a need for greater attention to the interrelationship between substance use disorders and trauma, given that sexual assault and abuse frequently trigger substantial rates of substance use disorders.Science Infrastructure: Encourage collaborative efforts with:  federal agencies including the Department of Veterans Affairs and SAMHSA; cross Institute and academic centers with brain banks and genetic material depositories; and professional organizations such as APA, American Association of Addiction Psychiatry, American Society of Addiction Medicine, and others. Develop and mentor well-trained female and underrepresented scientists in the drug abuse and addiction field at all levels. Establish a partnership between the APA and NIDA modeled after the highly successful Program for Minority Research Training in Psychiatry (PMRTP), which was funded by NIMH, to lead young researchers into the field.Unifying Themes:  Consider bringing this section to the front of the draft to assist readers in placing specific strategic priorities in context. In order to ensure that NIDA’s work addresses the full breadth of the U.S. population, include factors such as age, race, ethnicity, gender, sexual orientation, gender identity and social determinants of health.The following paragraphs delineate our detailed response to each area of NIDA’s draft strategic priorities:Basic NeuroscienceAPA proposes additions to the draft priorities in this area.Neurobiological CorrelatesWith regard to the improvement of understanding of brain circuits related to drug abuseand addiction at the cellular, circuit, and connectome levels, neurobiological correlates of vulnerability to addiction should also be included. Another area in the category of basic neuroscience that deserves attention is treatment targets, which should be a consideration of the neurobiological correlates of recovery.Comorbidity of Substance Use Disorders and Chronic DiseasesAPA requests NIDA bolsters its attention to the comorbidity of substance use disorders and medical illnesses. Thanks to previous NIDA research, it is well recognized thatsubstance use disorders are a significant contributor to the severity, morbidity, and mortality from many illnesses, including cardiovascular disease, gastrointestinaldisorders, HIV/AIDS, and pain disorders. APA recommends that NIDA expand its support for collaborative research between psychiatry and general medicine to furtheraddress these comorbidities and develop an array of effective interventions.4DiversityDrawing on one of the aforementioned unifying themes of diversity, it also is importantto consider the role of race as a determinant in the prevalence of co-occurring disorders. This issue is particularly relevant among racially diverse, vulnerable populations experiencing what has been referred to as “the triple whammy” of mental illness, addiction, and chronic disease, particularly HIV.Clinical and Translational ScienceAPA would like to suggest augmentation to NIDA’s vision in this area.Bidirectional Research, Functional Measures, Animal Models and Complex AddictionsWe recommend that NIDA consider supporting the translation of bench findings to clinical research in humans, as well as research on strengthening bedside to benchapplications (bidirectional research). With regard to clinical and translational scientific approaches, we recommend the inclusion of functional measures along with biomarkersof addiction, resilience, and recovery to enable personalized treatment. Clinical and translational research could also be used to assess the applicability of animal models or addiction mechanisms identified from animal models for human addiction vulnerability and treatment. APA encourages NIDA to support efforts on the treatment of complex addiction involving multiple substances.Age and Developmental ConsiderationsWhile addressing clinical and translational research domains, it is essential to concentrateon populations of study for focused developmental efforts including adolescents, young adults, and geriatric populations. One example of this is the need for research on addiction to prescription and pain/benzodiazepine medications and interventions for withdrawal in older adult populations.Dissemination of ResearchAPA strongly supports NIDA's dissemination of research and implementation of science so that evidence-based practices are dispersed to the community. NIDA's Clinical TrialNetwork (CTN) is an outstanding example of this important public health concept.Substance Use Disorder Treatment in Integrated SettingsChoosing where and how to invest finite resources is critically important. APA supportsNIDA's strong emphasis on the identification and evaluation of high-quality, cost- effective models for substance use disorder treatment services in integrated care settings. However, APA recommends this work build on the current excellent NIDA efforts (e.g., the development of screening tools for primary care and other healthcare professionals to assess patients or clients for tobacco, alcohol, and other drug use) to begin to focus on development of evidence-based approaches to substance use disorder interventions in these settings, such as the primary care opiate dependence intervention program.6 Theseactivities highlight the importance of integrating primary care with behavioral health components.There is a robust and growing research base documenting the ability of integrated care models to improve health outcomes. More research is needed on the dissemination and implementation of these models in a wide range of real-world practice settings, as well ason increasing our understanding of the economic impact of integrated care. APA enthusiastically supports research on the responsible integration of technology into all levels of the health care system, in the service of enhancing clinical interventions, and improving patient outcomes.Similarly, mental health services are benefiting from a growing interest in the development of collaborative care programs. Indeed, there is clear evidence of the role for integrated care in managing mental illness and reducing the disease burden of comorbid chronic conditions, such as hypertension and diabetes. Furthermore, the work of Jürgen Unützer, M.D., has identified that racial/ethnic minority women may have a more robust response to collaborative care programs than White (non-Latino) counterparts from similar socio-economic backgrounds. However, there is still a need for more research identifying effective models for the integration of substance use disorder treatment into primary care clinics. This is an additional area where NIDA can make a significant contribution.Medications for Addiction TreatmentAPA is appreciative of the development efforts on treating addictions that are currentlywithout FDA-approved medications. APA suggests these efforts include the treatment of addictions both with and without FDA-approved medications. Currently, FDA-approved medications for addictions do not lead to completely satisfactory outcomes. For example, both bupropion and varenicline (FDA-approved medications to assist with tobacco smoking) have a 1-year abstinence rate of approximately 10%, which is only double the success rate of people trying to quit without medication. Clearly, there is a great need for medications with better efficacy. A recent study showed that varenicline combined with nicotine replacement therapy was more effective than varenicline alone in achieving abstinence from tobacco but further study is needed to assess long term efficacy andsafety. 7Comorbidities of Substance Use Disorder, HIV/AIDS and Hepatitis CAPA asks that NIDA consider expanding its focused development efforts in its strategic plan to researching population-based strategies for treatment adherence in patients livingwith substance-related disorders, HIV, and the hepatitis C virus. Translational science such as this will be critical to ensuring that clinicians, substance abuse counselors, andothers have effective tools to curb the HIV epidemic. As research continues to show promising HIV-prevention interventions in drug abuse treatment settings, a cascadecontinues to exist in which the rates of treatment adherence declines for persons living with HIV and substance-related disorders who were previously linked to care.8 APA believes that continued research in treatment adherence strategies is a key to preventing the spread of HIV/AIDS and improving the vitality of patients living with HIV and asubstance-related disorder.Furthermore, the medical field has concluded that those currently most at risk for HIV are black men who have sex with men (MSM), yet there are still unmet HIV-related service delivery needs among black MSM.9 Additionally, recent evidence has shown that social determinants such as incarceration, stigma, discrimination, social isolation, mental health disparities, or social networks play a significant role in the elevated incidence rates of HIV.10 APA asks that NIDA further consider including investments in research of preventative biopsychosocial interventions that aim to meet the needs of dual-minority populations, such as the black MSM community, into their strategic plan.Public HealthEffective progress in the prevention, reduction, and recovery from substance usedisorders is a complex undertaking. Of note, prevention of substance use disorders is not thoroughly delineated in the current draft strategic priorities. In the realm of public health and the need to increase the public health impact of NIDA research and programs, APA has a number of suggestions to expand upon prevention priorities in the draft strategic plan.Cost AnalysisConducting research on costs associated with drug abuse and the economic feasibility oftreatments would be helpful to the field.Publicizing NIDA ProgressGreater dissemination of NIDA progress, initiatives, research, and education to outletswith strong public health impacts would be useful, including the health media. In particular, support for studying the efficacy of NIDA’s and other organizations’ public health messages, especially to vulnerable groups, such as adolescents, is crucial.Training of Clinicians in Public Health SettingsImplementing public health strategies for substance use disorders necessitatesimprovement in the training of clinicians at the front lines of public health, including developing and arming them with tools for clinical implementation to decrease the research-practice gap. A critical component of developing well-trained clinicians at the forefront of public health is mentorship of trainees interested in public health leadership to help address workforce shortages, an area for which NIDA is urged to consider continuing its robust support.Diverse PopulationsAPA requests that NIDA further improve the public health sector's understanding of how interventions should be tailored to meet the needs of diverse populations (e.g., gender,race/ethnicity, sexual orientation, gender identity and limited English proficiency). A specific example related to this is the recent decriminalization of non-medical cannabisuse in Washington State and Colorado. There has been an emergence of sales outlets located in communities of color. The APA suggests that NIDA consider assessingpatterns of legal sales, drug use, and disparities in impact, for example, co-location of drug oases in food deserts.Connection between Substance Use Disorders and TraumaAPA strongly encourages NIDA to focus attention on the interrelationship between substance use disorders and trauma. The field of psychosomatic medicine offers a uniquevantage point to see a powerful interplay between trauma, mental illness, stigma, addiction, and the costly medical consequences of unrecognized/untreated conditions.Data reveal that sexual assault/abuse frequently results in substantial rates of substance use disorders, and substance use disorder treatment may precipitate re-emergence ofPTSD symptoms. NIDA is uniquely positioned to advance this research through its Clinical Trial Network.Science InfrastructureEnhancing the national Science Infrastructure is required to support advancements in science. APA appreciates the suggested areas of focus in NIDA’s draft strategic plan andoffers additional input.Fostering CollaborationAPA recommends that NIDA further strengthen its collaboration with the Department ofVeterans Affairs (VA) and the Substance Abuse and Mental Health Services Administration (SAMHSA). NIDA's cooperation with the Department of Defense and the VA is critically important to advance the development of non-opioid pain management medication. Cross-institute/academic center collaborations with brain banks and other biological material depositories (such as genetics) will lead to important partnerships and advances in the field; this will require concerted efforts across the NIH Institutions. APA offers its assistance to increase collaborative efforts between NIDA and professional organizations including the APA, American Academy of Addiction Psychiatry (AAAP), American Osteopathic Academy of Addiction Medicine (AOAAM), and the American Society of Addiction Medicine (ASAM).Increase Diversity in the Scientific WorkforceWith regard to the development of human resources to augment the science infrastructure, APA requests NIDA's further efforts to cultivate well-trained female andunderrepresented scientists in the drug abuse and addiction field at all career levels. Training should include health disparities and cultural competence. Relatedly, more emphasis on the mentoring of young scientists, particularly women and under- represented minorities would be helpful to the field and would have a positive impact on patient care. APA has had great success in the past partnering with NIMH in the development of such a program, the Program for Minority Research Training in Psychiatry. This program was extremely successful, leading to the development of over 500 psychiatrist researchers from underserved and underrepresented populations whohave achieved at the highest levels of science.11 Such a program focused on women and minorities could easily be duplicated involving a partnership between the APA andNIDA.Increasing the Pipeline of Scientific ResearchersAPA recognizes the federal funding environment has impacted all of NIH. Difficultdecisions have been made at every Institute to adapt to flat research financing. Nevertheless, APA is concerned that the mechanisms to fund training and mentorship are declining and request NIDA re-examine these tools which are a critical area to develop researchers. Of particular concern to the APA is the declining number of physician- scientists and the significant delay in funding RO1 grants for young researchers. The struggle for young researchers to be funded has had an adverse effect on building the scientific workforce. Current fiscal pressures have negatively impacted research program grants (P30, P50, P60) which are utilized to develop local hubs with strategic scientific focus that can support training.  NIDA recently limited Centers to two periods of funding. APA requests NIDA revisit this funding policy to more efficiently develop sustained research programs and further develop scientific researchers on critical topics.Unifying ThemesAPA suggests that the section on unifying themes is better suited for placement at thebeginning of the plan so that each point can be considered as readers review the specific strategic priorities. Further, APA recommends this section be expanded to include a number of the following important issues.Integration of Behavioral ProcessesThe integration of behavioral processes that underlie drug abuse and addiction is a criticaland overarching issue that APA suggests NIDA give prime consideration in drug abuse research.Chronic Pain SyndromesTaking into account the treatment and prevention needs related to comorbid chronic pain syndromes and other psychiatric disorders is another example of challenges facing ournation that can guide NIDA's unifying themes going forward.DiversityIn order to ensure that NIDA’s work addresses the full breadth of the U.S. population, the impact of factors such as age, culture and ethnicity, and social determinants are areas thatAPA suggests that NIDA explore. APA applauds NIDA's dedication to studying the developing brain. The differential effects of substance use and substance use disorders onthe brains of individuals vary at different stages of development, including late childhood, early adolescence, middle and late adolescence, young adulthood, and latelife. NIDA may wish to consider expanding its research on cannabis use (medical or recreational) in the older adult population. APA supports NIDA's research on the impact of race/ethnicity, sexual phenotype, gender identity, sexual orientation, and social determinants on drug abuse. This includes research focusing on culturally- and linguistically-appropriate services among groups experiencing health disparities, such as women and underrepresented and underserved minority populations.APA appreciates the opportunity to comment on the NIDA draft strategic plan. I look forward to further discussions and continued collaborative initiatives.

infrastructure, public health, clinical and translational science

  • In thinking about NIDA’s strategic plan, we cannot help but think of Galileo, a scientist ahead of his time hobbled by the establishment of his time, especially the Church. NIDA is certainly familiar with the translational science problem of getting clinical practitioners to embrace and adopt new findings into their professional practice. A greater obstacle currently, it seems to us, is how NIDA deals with the uninformed, the backward, the willfully ignorant, and the outright hostile in the public at large.  How does NIDA move public opinion forward from thinking and belief systems that range from magical and mystical, to Puritan, moralistic and authoritarian, to marketplace selfishness and greed – all of which impede, oppose or defy progress NIDA makes? This “disease,” if you will, spreads backward as well, infecting those purporting to treat substance use disorder, making translation science all the more difficult to enact.  Hotbeds of the “disease” are those pseudo-scientific and/or spiritual organizations which resist forfeiting their stake in addiction treatment.  None of this is news to NIDA, to be sure.  What we are suggesting is an urgency to overcome these obstacles.  All the progress in the world is for little or naught until these roadblocks are addressed or circumvented.Herewith, in no particular order thoughts, ideas, suggestions from two concerned laypeople: NIDA, among others, recognizes the correlation between addiction and mental illness.  How do we make it imperative that doctors in hospital ER’s understand this? How do we make this part of their certification before they begin practice?   We need to untie the hands of doctors who are aware so that patients, especially those presenting as overdosed, can be given proper psych evaluations that result in appropriate treatment rather being released the moment they are “stabilized?” A year ago we learned of a  potential arrangement between the chemical dependency unit of a hospital and a treatment facility, both in NYC.  If the hospital could not find a bed for full and proper treatment, the treatment facility would pick the patient up immediately and begin treatment – regardless of insurance status.  In the end, this plan did not work out.  The problem remains…how do addicts get treatment the moment they request it?  How can they be embraced, not turned down when they seek treatment?  The moments when addicts seek treatment willingly are too few to be wasted.Is it possible to mandate enforced treatment?  Similar to or the same as existing laws in Massachusetts? Section 35 is a Massachusetts General Law that allows a judge to "involuntarily commit someone whose alcohol or drug use puts themselves, or others, at risk."The law allows for the individual to be put into an inpatient substance abuse program for up to 90 days, but the level of commitment and the location of treatment varies. The section allows families and/or the judge to choose a licensed treatment facility. If no beds are available, the individual might be sent to a separate unit at the correctional facility at Bridgewater for men or Framingham for women.  Is it possible to mandate prolonged treatment for anyone who arrives at an ER having overdosed and/or having received Narcan?How can the quality of medical training be improved so that residents and interns in ER’s are properly educated and properly sympathetic to the patients they treat?  Currently many are ignorant or even outright hostile about SUD as a mental health issues. How can we ensure the advice they give is current and evidence based? ER’s are a flashpoint where SUD manifests itself.  How can NIDA help ensure best practice initial treatment in ER’s? It needs to be more than a couple of Xanax and sending people on their way.  How do we avoid kicking people out of SUD treatment, because they are uncooperative?  Addiction treatment should be about saving lives, not cooperation?The rules about who treats addicts and how much training they have need to be much more stringent.  Merely being in recovery oneself is not sufficient to treat someone with SUD,  especially with co-morbidity a prevailing issue. 60 hours of training, for example, is grossly insufficient.  How do we get real physicians to be available more prominently and more often, or at all, at treatment centers?  The deficit of certified doctors treating addiction must be addressed. There has to be an easier way for families to save a child’s life than to deal with HIPAA obstacles.  Being incapacitated is part of the disease.  How can family members be appropriately engaged and informed during the treatment process?  Age 18 should not be a magic cutoff point, especially with a disease that affects the capacity for good judgment in those suffering from the disease.  Is NIDA doing any research with those in long term recovery?  What can we learn about those who are leading sober, productive lives over a significant period of time?How can NIDA contribute to the network of family members of both those lost to SUD and those in various stages of recovery?  How does NIDA recognize the family aspect of this disease?How can NIDA help frame information about SUD to young people so that what they hear doesn’t seem to be “cranky old people talking at them and scolding them?”How can NIDA turn the “Don’t do drugs.” message into positive action?  How can young people become part of the solution?  How might NIDA generate a list of questions kids might ask their parents about drugs?  How do we reach parents and teachers? How do we reach those content in their ignorance?  Can NIDA help prioritize insurance regulations that need to be changed at any and every level of government?How can any institution’s SUD treatment be made more transparent, so that families and institutions know what they are getting?  Can NIDA help set universal standards, for utilization review (assuming we have to live with this beast)?How can NIDA stop the bickering and infighting over MATs and between MATs.Can NIDA help establish guidelines for hospitals and ER’s for admission and treatment.  We can no longer afford to hear, “Patient doesn’t meet the criteria,”  whatever that means. What criteria?  Whose criteria?Is it possible to establish or organize a model ER, a model treatment center, model sober living houses, etc.  All under the same roof, or separately.  Models of best practices that can be followed elsewhere?  To have at least one institution where the gap between “bench and clinic” is minimal?  We realize finding solutions to these questions may be overwhelming or beyond the strict purview of NIDA’s charge.  Our big question is to what extent can NIDA engage in “translational psychology” so that the ideas and attitudes that perpetuate the stigma surrounding addiction can make way for proper science and best practices to prevail.

Public Health, Basic Science, Clinical and Translational Science

  • Below you will find my comments for consideration for inclusion in the forthcoming Strategic Plan;1. As an overall comment to be included under the Public Health Strategic Priority:Recreational use of substances of abuse has been pervasive throughout history across cultures and societies. Driving forces for its continued existence are much more than physiological and behavioral; deriving much of its persistence to socio-economical factors that maintain and perpetuate its existence. While the mission of NIH certainly is consistent with the focus for this five-year strategy on the basic science and clinical treatment of individuals with SUD; what is missing is the commitment of NIH, and in this case NIDA, to play a prominent role in addressing the proliferation of addiction by attacking the problem at its roots; and that is the “inoculation” of our children through innovative early educational programs that would include strong prospective outcome studies to examine their impact during preteen and adolescent years. Resources could be shared with SAMSHA for a concerted effort and integrated within the educational curriculum through ‘caring for our brain” initiatives just as we are doing with traumatic brain injury and the successes that we have achieved with the use of helmets.  To not include such an objective in this Strategic Plan within the NIH as a way to encourage the active support of our scientists in the implementation of such efforts would be a mistake; since it is the excitement of the science and progress in brain research that must be the foundation for the design of such addiction prevention programs and will ultimately lead to success and differentiation from just another pedagogical program by departments of education. 2. Comment to be included in the Basic Science Strategic Priority (within bullet #9):There should be an effort to highlight a focus of research into an improved understanding of descending brain pathways for modulation of both chronic neuropathic and visceral pain. Such research efforts should incorporate and support a more thorough understanding of placebo response and its importance to clinical research design for alternative treatment strategies for pain. Such research will impact clinical trials well-beyond the therapeutics of pain.3. Comment to be included in the Clinical and Translational Science Strategic Priority:One of the key issues facing the discovery and development of new treatments for addiction is the translation of basic neuroscience research into the clinical setting. To this end I would reinforce the need for valid biomarkers including novel provocative tests that would increase our success in translation to clinical trials, but also might serve to identify individuals at particular risk for addictive behaviors and provide opportunities for preventative interventions.I will look forward to following your progress.
  • al Institute on Drug Abuse, National Institutes of Health;As the Executive Director of the Greater Lowell Health Alliance of CHNA 10 (GLHA) and representing GLHA's Substance Use and Prevention and Maternal Child Health Task Forces, I would like to respectfully submit the following written comments for the 2016-2020 Strategic Plan:Suggestions-Continue research on whether some people are genetically predisposed to becoming addicts.More research on why children with behavioral problems early in life become substance abusers later in life.Children between the ages of 3-6 do not have access to services. Early intervention ends at age 3 and the public school system takes over at age 6. The children between this age group need some intervention too. It is possible that they end up abusing substances later on in life as a way to self-medicate .There is an increase in Ritalin being given to preschoolers.  Research needs to be conducted on whether these children later become substance abusers as they have been on an addictive substance for so long.More research needs to be conducted to produce more non-addictive options for detox as has been done for ADHD.More research should be conducted on cannabidiol (CBD).There is need for tighter legislation on Suboxone. There is no follow-up of clients using it. Clients should be  mandated to attend group sessions . Physicians should also do follow-up of their patients. With methadone, clients have to go for counseling but there is no such requirement for clients on Suboxone .Suboxone is being misused and clients are buying it in the streets. Those clients who are unable to get hold of Suboxone end up using Percocet's or heroine.It takes several days to receive drug test results and most do not test for Suboxone.Transportation should be provided for clients who are in treatment. Drug dealers deliver to their clients but treatment centers do not provide similar services.There should be a policy change that allows DCF to get involved when pregnant wome n are abusing substances. Currently DCF can only get involved if there are other children in the household or when the baby is delivered,by that time it is too late for the newborn as he/she is born with an addiction .Doctors should be mandated to report to the hospital if a pregnant woman is abusing substances. This way she can receive detox services sooner.More work needs to be done to ensure pregnant women who ab use substances have access to Early Intervention Partnerships Programs (EIPP).1ChallengesSynthetic drugs are frequently changing and evolving, it is difficult to catch up. A recent case of a youth overdosing in Chelmsford on "smileys". Law enforcement had no knowledge what that substance was.Clients with a dual diagnosis (comorbid conditions e.g., mental illness, chronic pain). Half-way houses will not accept them if they have a prescription for a narcotic. This needs to be addressed as these clients are left with no treatment options.Re-imbursement rates from insurance companies are low and some insurance companies are not paying for detox.Detox centers will not take in women who have just left the hospital after delivering a baby. They require that the client must first test positive for a substance in order to be admitted. If the client uses, they get into trouble with DCF.There was little preparation for the legalization of medical marijuana. This has created problems, for example, law enforcement is not able to arrest someone buying marijuana if they have a Medical Use of Marijuana Program ID card.More detox options should be made available for people who are in jail but have not been sentenced yet, for example methadone, Suboxone . Currently this population has no services and is at highest risk of overdosing once released.Permission must be obtained to test adults for substances.Thank you for the opportunity to provide input on the research priorities to be included in the NIDA Strategic Plan. These comments were gathered at a special meeting held by the Greater Lowell Health Alliance, a coalition that is comprised of public, non-profit and private sectors working together to build healthier communities through community-based prevention planning and health promotion . Please let me know if you need further clarification.

Public Health, Clinical and Translational Science

  • SPECIFIC ISSUES RE. OPIATE ADDICTION [OPIOID DEPENDENCE]- Please study sublingual naltrexone for opioid over dose treatment by non-medical persons; at lest the old Trexan formulation was readily absorbed through the gingiva (gum tissue), i.e. without being swallowed, leading in very small dosage very rapidly to withdrawal in methadone treated patient – it also has advantage that it last long enough to avoid patient going back into a coma after a very short-acting antagonist (naloxone) wears off if patient over-dosed on time-release or long-acting opioid. - I wrote a paper on Neonatal Abstinence Syndrome that has been ignored – it is relevant and needs to be duplicated and described techniques may be broadly taught. http://www.humane-civilization.org/Neonatal%20Abstinence%20Syndrome.html [the main point is the mother's stress level during the later part of her pregnancy and possibly also during childbirth itself greatly aggravates likelihood of NAS; in our study, NAS was not related to methadone dose, prematurity or any other factor, except participation in our childbirth preparation groups/counseling that included teaching autogenic training (AT) and self-hypnosis. Opiate addicts tend to be more afraid of pain than average populations and pregnancies are particularly stressful for them because of stigma, fights about who makes the best parent for the newborn, overcritical behavior by CPS and hospital staff, if there is any opioid or marijuana in the mother's urine drug screen when she goes into labor. Needless to say, these pregnancies are hardly ever planned and, in anybody's mind, desirable. I believe the mothers' stress hormones that flood the late fetus significantly aggravate NAS and NAS-like symptoms in newborns. How the newborn is then handled often makes things worse, and a women being interrogated by a poorly trained, unsympathetic CPS workers within hours of giving birth is not conducive for her to then comfort her newborn.]Please study contagion of addiction: address how main prevention is treating patients – there always appears to be major contagion; disturbed young people do not invent heroin addiction! (Compare Swiss experience). And address the utter lack of health education concerning addiction and opioid addiction treatment, the global misunderstanding of opioid maintenance (not a continuation of addiction or simply “substitution” – abuse-addiction means that there is a pattern of “bad”, destructive behaviors, doing something to feel quickly better when one should know that it is not ethical, etc. Study the catastrophic effect of the broad assumption by professionals and the population at large that opioid maintenance is immoral, and that methadone makes people ‘stupid’. Please study how the lack of education efforts probably is the main cause of the growing opiate addiction epidemic and the lack of proper treatment (responsibility of SAMHSA/CSAT, the CDC, the ‘drug czar’, state health departments, etc.http://www.humane-civilization.org/Abuse%20and%20Addiction.html- Address need for OTPs in every four-county area (pilot studies needed, then rapid duplication of model): rural clinics of family physicians/nurse practitioners, obstetricians, infection specialists, etc. must be able to function as small OTPs; maybe sending stabilized patients to treatment center for monthly groups and individual therapy but providing closely supervised methadone (buprenorphine for addicts with low tolerance) locally. OTPs must be medical-psychiatric clinics (studies showing benefits of well-staffed medical-psychiatric OTPs as compared to "franchise style" OTPs without adequate medical/psych. trained staff). OTPs should not be counseling centers with physicians signing off on decisions made by non-medical counselors and administrators. Main staff should consist in physicians, physician assistants and/or nurse practitioners, and registered nurses. Larger OTPs should make efforts to treat psychiatric conditions (mainly psychotherapy approaches), also treat pain non-pharmacologically and have staff that can tentatively diagnose other medical conditions, treat simple infections and make proper, meaningful referrals for the treatment of other disorders, etc.- SAMHSA should research the deleterious effect of the "war on drugs", the efforts to make physicians uncomfortable prescribing pain medications to patients with propensity to abuse behaviors without offering proper maintenance treatment for all these patients; driving addicts who previously used opiates obtained from unethical doctors to the heroin market (no attempts to move these patients into OTPs).- SAMHSA may reevaluate the lack of benefits of loosely prescribed Suboxone. While Prescriptions of opioids increased, OD deaths increased proportionally, with hardly any effect of the millions of Suboxone (buprenorphine) prescriptions on the continued rise in OD deaths from opioid pain medications. SAMHSA research should show, what structure is needed for buprenorphine treatment to work. - SAMHSA should study benefits of comprehensive temporary [years, not months, not decades] opioid maintenance combined with psychiatric treatment: we find, anecdotally, that temporary maintenance has a very good prognosis if treatment addresses all aspects of pathology and all types of abuse behaviors, including psychological abuse (NOT continuing smoking - a gateway drug [several of our patients started smoking in "rehab"!], and/or NOT switching from opiates or alcohol to promiscuity, food addiction, etc.). It is extremely relevant that people do not believe that methadone only works while the person is taking the medication with almost certain relapse after taper. - SAMHSA should study how to taper off opioid maintenance with best results: our experience is that it should be in steps, not continuous, even, slow decreases. Stabilizing on medium and low dosage before final taper show patient what “normal” life is like and that they are not dependent on the high dose; while stable for months on a medium dosage, patients know that intermittent anxiety, sleeplessness and ‘normal’ aches are not related to a dose decrease. For readiness to discontinue maintenance treatment, see other points. GENERAL ISSUES REGARDING SAMHSA RESEARCH: - SAMSHA must avoid supporting specific treatments that are not dealing with principle underlying weaknesses, vulnerabilities, etc. E. g. creating vaccines to block effect of cocaine and/or opiate molecules is contraindicated and dangerous: it drives patients from known, fairly safe drugs (little toxicity unless overdose or combination of drugs) to unknown, potentially highly toxic drugs. - Changes in brain circuitry and equilibrium of neuro-regulators due to substance abuse are hardly relevant for prevention and treatment. Researchers must consider: all major learning and experiences change brain dramatically: e.g. learning down-hill skiing or flying jet, learning to shoot humans, going to law school, becoming sexually active, going through desired pregnancy and childbirth, going through unwanted pregnancy and childbirth with consequent fight over and loss of child, experience perceived as extremely traumatic because it contradicts all cultural expectations (e.g. being sodomized; sadistic treatment in ways unknown within culture). - SAMHSA should avoid studying complicated, theoretical connections and relationships that are clinically irrelevant for treatment and prevention: virtually all substance abuse disorder patients are multiple diagnosis patients; there are always interactions that can lead to vicious cycles; each aspect must be addressed in usually multiple ways, e.g. EMDR with PTSD while teaching awareness meditation, utilizing cognitive, interpersonal and dialectic therapy approaches, ACT, etc.; teaching self-hypnotic techniques including Autogenic Training (AT), etc. - Please make sure that SAMHSA does not give in to pressures, e.g. calling pseudo-scientific religious approaches ‘therapy’ or even ‘evidence based’. For many, fostering spiritual tendencies has broadly beneficial effects, but it is often combined with negative factors, e.g. in 12-step meetings, people rarely distinguish between impulsive lapse in a weak moment, quickly getting back to positive acting/thinking, versus relapse, giving in or giving up, mentally consenting to aberrant behavior; furthermore, the term ’disease’ creates image that normal brain is histologically damaged (when it functions well even though it was misused – compare computer abused for watching pornography - the computer then brings up such sites no matter what key is hit). Abuse-addiction is neither a progressive nor a permanent 'disease'; it is better interpreted as a propensity towards a pathological behavior pattern that is learned, and it should represent a phase in life from which many people eventually move on, more with but often without treatment. Belief in a god intervening in one’s behalf easily wanes, particularly after a ‘good’ loved person has horribly bad luck, has a major accident or illness and/or is abused and dies. - SAMHSA should consider more research in the understanding of instincts that apply to humans, research based on the work of Erich von Holst, Konrad Lorenz and particularly Irenäus Eibl-Eibesfeltd; what is applicable form primate research by Frans de Waal, Jane Goodall, etc.; modern research on the CNS (Demasio, etc. Much literature collected and interpreted by psychologists such as S. Lyubromirski, S. Pinker and M. Gladwell contains much material that is valuable in the treatment of addiction-multiple diagnosis patients - SAMHSA may work on an understanding of substance abuse as artificial instincts: characteristics of substance abuse very much like instinct (ethological research; research of nuclei, connections and neuro-transmitters/neuro regulators in central nervous system [CNS]) As in instincts, triggers lead to emotions which drive actions; what is associated with triggers and ‘instinct fulfillment’ is also reinforced, is seen as beautiful and valuable; there is satiation of instinct after which only strongest triggers have influence; and there is appetence behaviors (related to the so-called “seeking system” in CNS). Role of dopamine in instincts and substance abuse with related learning is essentially the same. - Application of understanding how instincts are strengthened when used, e.g. frequent fighting makes person want to pick fights; and how instincts are weakened, erased: by frustrating action, frustrating enjoyment of thoughts and memories, not positively identifying with others/fictitious characters who commit behavior, etc.; gradually changing meaning of triggers, e.g. seeing drunk person and later alcoholic beverages as disgusting, thoughts and impulses leading to shame and guilt. Examples of erasing instincts: stopping physical fights or promiscuous acting out, learning to see them as immature, ‘primitive’, disgusting, etc. Learning to see triggers in different way. Many people virtually erase sex drive, e.g. when entering monastic life, or, before contraception, if women did not want/were afraid of having additional children; any sexual stimuli and advances may then feel disgusting. - SAMHSA may confirm, further develop our findings: isolation, feeling completely alone e.g. after abuse (when PTSD symptoms), leads to vulnerability to opiate addiction and probably also alcohol abuse (among our OTP patients, we have much more patients with PTSD symptoms than expected, and we have much less twins than would be statistically expected.) - SAMHSA may confirm, further develop our findings: A significant number of our OTP patients have history of anorexia nervosa, all did relatively very well while on methadone or buprenorphine. It appears that temporary opioid maintenance should be considered a first line treatment for severe anorexia (patients function optimally with much reduced symptoms of anorexia nervosa)RESEARCH ON TEACHING ETHICS AND EARLY INTERVENTIONS ADDRESSING CHILDREN'S PSYCHOLOGICAL NEEDS: Research to show effects of early teachings (starting in grade school level) and immediate proper intervention when psychological-social problems occur. People of all ages need to learn about ethics and SAMHSA should address how ethics teaching decreases irresponsible behaviors, including premature and irresponsible sexual activities, and drug abuse, comparehttp://www.humane-civilization.org/HC%20manuscript%203.4.htmlStudies should address: children learning to see things from many perspectives, learning broad, compassionate empathy, learning to always look "at the big picture", one's future self within family, clan, group, and humanity, etc. Such learning is expected to decreases irresponsible behaviors, including abuse-addiction behaviors. Teaching to see ‘the big picture’ as we move from present to future helps with self-control, with less discounting of future (e.g. children learning to do better on 'marshmallow test'). Practicing self-control with specific exercise, supported by being aware of future and always considering question “will I later regret this action or inaction?”, leads people to do better in many spheres, decreases impulsiveness and all forms of abuse behaviors. - Young and older people need to learn: substance abuse is “cheating” the emotional-behavioral system “feeling good for no good reason”, interfering with healthy development, distracting from real issues, wasting time, harming loved ones, etc. [Addressing substance abuse is not for patient, it is primarily for his/her loved ones, including future children.]Teen years are time of major psycho-social and factual learning, not time to primarily feel good and enjoy self. Studies should address how learning that working issues out and studying in broad range of sciences and arts decreases abuse-addiction behaviors, is fulfilling and giving the young life meaning. Teaching in schools must help children define their personal culture. - Studies should address how separating boys and girls for much of their school education is helpful – the CNS of boys and girls are different; schools tend to teach little boys as if they were girls, thus often loosing their interests, and teens are taught as if they were all boys (compare work of Leonard Sax: Why Gender Matters, Girls on the Edge, Boys Adrift). The psycho-social changes for boys and girls are very different; e.g., boys more than girls, need to learn how to rebel and compete within ethical realms; girls, more than boys, need help steering through the major changes in body, physical roles, real loss of control (reproductive functions) and expectation to give up control versus strengthening areas they have control and developing specific potentials that fit their personal culture. Too much interactions between boys and girls is also very distracting for most teens; girls may be reluctant to show when they are smarter than boys, formulate statements like questions to be affirmed by a male, etc.; males often feel they have to show off in dangerous and irresponsible ways. - Studies should address optimal level of structure for children-adolescents, limitations of choices in education, food, free time activities, etc. Self-expression should be within set limits. Children of all ages probably benefit from being involved in different forms of safe sports, artistic expressions with limitations in media and techniques, classical vocal or instrumental music, broad theoretical learning (sciences and humanities) and practical learning (e.g. wood working, cooking, gardening, appliance repairs, construction work).- Studies should address benefits concerning drug abuse prevention effect derived from addressing psychological issues in children-adolescents, treatment if there are traumas and/or chaotic family situations, etc Studies may address (confirm our anecdotal data) that for girls, intercourse often leads to down-spiral with substance abuse starting or becoming much worse. Girls who are sexually active at early age generally need counseling and support, learning that having a boy friend and/or being popular is unimportant, hardly relates to being happy as adult. Studies may confirm benefit of early, sensitive intervention.The range of needed studies is great, however, small studies, partly anecdotal and retrospective, are more valuable than huge studies that try to bring things onto some narrow denominator and ignore most issues. [Who cares how many drug-free urine samples a patient gives who feels miserable, who is over-sedated or who does virtually nothing except going to AA meetings? Who cares if there is some ongoing drug use behavior while the patient is definitely and continuously improving in most respects?] Also, studies should avoid 'cook book style treatments' and '[over]structured interviews'. Treatment starts with the first contact and the initial interviewer of a child or drug abuse patients has to be sensitive, adapt questions to individual, omit some and elaborate in other areas of evaluation, start addressing hopelessness before completion of 'intake', etc. "Evidence-based" often means, statistically better than uninterested routine contacts, but is often inferior to a sensitive, individualized, fairly comprehensive but eclectic approach. Psychotherapy should always be a common-sense approach utilizing and derived from a broad understanding of humankind.
  • On behalf of its member boards, the International Certification and Reciprocity Consortium (IC&RC) welcome the opportunity to provide comments to NIDA for its strategic plan.  The challenge presented to our nation by substance abuse and addiction must be taken seriously, and innovative approaches will be needed in this new age of health care eligibility and delivery.  It is a widely held belief that there are no national uniform standards for the SA counseling profession, but this is a misnomer.  There is one common thread that binds counselors across the country. That is credentialing. IC&RC is the gold standard for professionalism and training in the field of substance abuse counseling.  IC&RC is the global leader in the credentialing of prevention, addiction treatment, and recovery professionals. Organized in 1981, it provides standards and examinations to certification and licensing boards in 25 countries, 47 states and territories, five Native American regions, and all branches of the U.S. military. Over half of all substance abuse counselors in the United States hold an IC&RC credential. Just as physicians are “board certified” in a specialty, addiction counselors are also certified, in one of seven pursuits specific to substance abuse treatment.  All of IC & RC’s credentials are based in the latest advances in neuroscience and evidence based practices.  Credentialed substance abuse counselors are far more knowledgeable about the biology, biochemistry, psychology, and sociology of substance abuse than the average primary care physician or nurse who has not been trained in the area.  A substance abuse counselor credentialed by IC&RC has undergone thousands of hours of training and supervision, as well has hundreds of hours of classroom education.  Substance abuse counseling is often an unheralded, misunderstood profession, especially by policymakers. SA counselors receive education and training specifically for the field of addiction treatment and prevention, and focus on nothing else but this single area of health.  IC&RC has the highest respect for NIDA’s mission and research, and has always enjoyed and valued its dialogues with the agency. Experts from NIDA have participated as Subject Matter Experts, assisting us in the evaluation and writing of our exams and credentialing standards, and have brought to the table an unmatched expertise in the need for evidence based practices   For decades, the substance abuse counseling field has struggled for recognition as legitimate health professionals. It is a workforce that treats a disease with such a social stigma that criminal justice is as important a policy priority as public health.  Recognition and approval has been sought from policymakers, third-party insurers, clinical supervisors, and other health professionals. NIDA’s collaboration with IC&RC has increased our visibility, and our credibility, in the eyes of many.The RFI asked us to address strategies that would increase strategic partnerships with the community (academia, pharma, biotech, healthcare organizations, policy makers, etc.) to enhance the dissemination of evidence-based research findings into policy and practice.  At present, NIDA pays a great amount of attention to the treatment and prevention of substance abuse by physicians, as is evidenced by their “NIDAMed” program.  However, physicians make up only a fraction- and a small one at that- of the health professionals who work with consumers in need of care for substance abuse.  NIDA needs to commit more resources to working with health professionals that work on both the single diagnosis of substance abuse and addiction, as well as those who work on co-occurring disorders.  These include substance abuse counselors, and other professionals whom are credentialed to work on the issue, such as social workers and psychologists.  Because there is such a shortage of professionals who work with substance abuse patients, there is even higher demand for efficient and effective treatment.  The most recent research on effective treatment protocols must reach the hands of all treatment professionals in a timely manner.As health care in America expands to reach more people than ever, substance abuse must take the same approach taken by other health disorders and diseases: the translation of research to practice, a highly trained workforce, and a high degree of public awareness. Substance abuse counseling is a rapidly growing profession.  According to the Bureau of Labor Statistics, “Employment of substance abuse and behavioral disorder counselors is expected to grow by 27 percent from 2010 to 2020, faster than the average for all occupations. Growth is expected as more people seek treatment for their addictions or other behaviors and drug offenders are increasingly sentenced to treatment rather than jail time.” As a result, our professionals more than ever need an arsenal of research and evidence to support their work- not only because the disease of addiction needs a cure, but because accountability in health care delivery is at an all time high. Substance abuse and addiction research must take advantage of the current situation and the opportunities it presents. Interest in substance abuse- amongst policy makers, the public, and health care professionals are also at an all time high.  A confluence of factors, including but not limited to the legal status of marijuana, a resurgence in heroin use, and the ever increasing abuse of opioid painkillers, has led us to this moment. As advocates and activists demand more action, NIDA must be one of the leaders in this fight. Its research, and perhaps more importantly its dissemination of this research, should lead the way forward, just as research led us to the advances we have made against modern plagues such as HIV, or even diseases no longer considered commonplace, such as whooping cough, small pox, or diphtheria.  The scientists studying addiction today can end a scourge that has plagued us for millennia, and their names can go along side Fleming, Salk, and Pasteur.It is our belief that research at NIDA exists for one reason above all others: to improve the treatment of substance abuse and addiction.  In this vein, we wish to see a continued emphasis on the translation of research into practice. NIDA has been a leading contributor in this arena, and has specifically assisted IC&RC be providing subject matter experts for the review of our exams and job task analyses. Addiction and abuse are just as costly to this country as cancer, hypertension, or diabetes, yet the research dollars appropriated to finding better substance abuse and addiction treatment pales in comparison to that of the institutes that study these other diseases. This must be remedied.  The economic impact of addiction and abuse either equals or outpaces that of almost every other disease, so the economic investment in finding cures has to keep pace.While policymakers have given substance abuse increased attention in recent years, they only do so in response to increased use in specific narcotics.  For example, for most of last decade, a large amount of legislation was introduced aimed at curbing the use and abuse of methamphetamine.  Over the first part of this decade, attention has shifted to opioids.  Congress responds to the drugs that make headlines, yet rarely- if ever- do they address the underlying disease of addiction. We believe it is the role of NIDA to emphasize- to both policymakers and the public- that no matter what advances are made in the fight against specific narcotics, the larger picture must always remain the effort to cure this one underlying disease of addiction.Nothing underlies this point better than the recent “21st Century Cures” report recently released by the House Energy & Commerce Committee.  Addiction is a disease that kills tens of thousands of Americans every year- dwarfing the mortality rates of HIV and Ebola- yet was not mentioned once in the aforementioned report.  This is a wake up call: addiction is not taken seriously as an epidemic, and it is not considered a disease. Any other disease that killed over 100 people a day would be at the forefront of a concerned congress.  NIDA needs to translate what it knows about this disease into a language that makes policymakers- and the public- understand its deadly impact.NIDA’s RFI asked us to address the issue of “Increased readiness to respond to emerging public health priorities (opioid overdose epidemic, potential consequences of marijuana legalization, changing healthcare landscape, emerging drug trends, etc.)” As healthcare- and substance abuse treatment- finds its way in a new world order, we will become more reliant than ever on protocols that are proven effective and efficient.  This includes research on treatment settings, treatment protocols, and a variety of other factors.  It is no longer an issue of simply how treatment is provided- also in need of consideration is the where, by whom, and when.  At present, NIDA does excellent work in the dissemination of its findings, but these efforts appear limited to major research grants or events, such as Monitoring the Future, or National Drug Facts Week.  Research in addiction and substance abuse treatment should be given the same attention and reverence usually reserved for breakthroughs in research pertaining to cancer or HIV.  While there has definitely been more attention paid to these advances over the last decade, more still needs to be done.  When a scientific breakthrough has the ability to improve the lives of millions of people, full advantage must be taken.  We believe that the NIH leadership has a responsibility to work with NIDA in order to put a brighter spotlight on these discoveries.  The Office of the Director should be trumpeting discoveries in addiction with the same vigor and excitement that they promote findings in the fight against better known diseases.The treatment of substance abuse and addiction is a continuum, and a complex one at that.  Often this continuum is broken down into three categories- prevention, treatment, and recovery. Yet even these categories can be divided.  Prevention strategies for youth differ from prevention strategies for other age groups- and other age groups do need prevention strategies.  Older Americans are abusing drugs at a rate never before seen, and at a rate not matched by other demographics. The over-availability of powerful prescription drugs has contributed to this, and new prevention strategies are in order.  Within treatment, we need to see more research done on the medical aspects of detoxification.  In many states, the only addiction treatment service covered by Medicaid is detoxification.  While this needs to change, at present, detox is the only bite at the treatment apple that many will get, so it must be done while guided by the most recent, proficient research.  In terms of other treatment protocols, treatment is far from one-size fits all.  There are setting considerations: inpatient, outpatient, intensive outpatient, and more. Settings can be hospitals, clinics, private treatment facilities, public treatment facilities, and on and on.  Then there are cultural and ethnic considerations to address.  Men and women approach treatment differently. Latinos, Native Americans, African Americans, and other ethnic groups have different considerations to address.  Special populations such as veterans, active duty military, and others deal with issues that can impact treatment and recovery.  We need to see NIDA fund research that takes all of these factors and variables into consideration.While treatment is a high priority, the best way to eradicate addiction remains prevention.  Research into effective prevention strategies would be a great boon to our prevention specialists, over 3,000 strong across the United States.  The entire American public knows that avoiding cigarettes is a prevention strategy for cancer.  Avoiding obesity is a prevention measure for diabetes.  Exercise can help prevent hypertension.  It’s as common knowledge as the sky being blue. Yet beyond being able to cite 30 year-old PSAs such as “Just Say No” and “This is your brain on drugs…” few Americans can cite effective prevention strategies for substance abuse and addiction.  It is incumbent upon NIDA to change this.  Not only has NIDA performed research on what prevention strategies are proven to be effective, they are committed to continuing this work well into the future. More of an effort must be made on dissemination, however.  This information does not reach the public at the levels it should.The treatment of substance abuse and addiction has seen great advances over the last decade through the use of pharmaceuticals that are accompanied by cognitive therapy.  We wish to see NIDA continue research on new products that will compliment these efforts, as well as continue research on the efficacy of existing pharmaceuticals in various settings.  Current medications have worked wonders for opioid dependence, but similar pharmaceuticals that can do the same for stimulants would be a game-changer.  In addition, we would request that NIDA begin to work with non-physician health care professionals who treat patients undergoing medication-assisted treatment.  As the development of pharmaceuticals to treat addiction advances, so should the science associated with the cognitive therapies that must be used hand-in-hand with these medications. NIDA has the resources and mission to research effective treatment protocols that can be employed by these professionals.  Peer counseling, long a tool in the arsenal of effective treatment and recovery programs, is growing quickly.  Peers are being utilized far more often, and in some jurisdictions receive Medicaid reimbursement for their services. Peer recovery is experiencing rapid growth, whether a peer recovery coach provides it, peer recovery support specialist, or peer recovery mentor. Peer support services - advocating, mentoring, educating, and navigating systems – are becoming an important component in recovery oriented systems of care. Sharing recovery experience is deeply rooted in the addiction field, but it is a newer concept in mental health.  As a result, there has been high demand for these professionals to meet certain standards, as they will be heavily relied upon in the future of substance abuse care. Inclusion of peers with practical experience on teams with degreed clinicians is increasingly being emphasized by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) - in both addiction and mental health settings. Outcomes include decreases in morbidity and mortality, as well as empowerment of service recipients.  IC&RC’s Peer Recovery (PR) credential is designed for individuals with personal, lived experience in their own recovery from addiction, mental illness, or co-occurring substance and mental disorders. NIDA should consider studying the efficacy of peer counseling, as well the treatment protocols utilized by this professionals. There is also an opportunity to study the process of recovery from the perspective of neuroscience.There are many regulatory issues that surround substance abuse treatment, which NIDA cannot fix directly, but can indeed contribute to a fix.  One example is the Institute for Mental Diseases (IMD) exclusion.  The IMD Exclusion was enacted in 1965 to prevent Medicaid funds from covering treatment in large psychiatric hospitals. Section 1905(a)(B) of the Social Security Act defines an IMD as any “hospital, nursing facility, or other institution of more than 16 beds, that is primarily engaged in providing diagnosis, treatment, or care of persons with mental diseases, including medical attention, nursing care, and related services.” When the law was enacted in 1965, substance abuse was widely regarded as a mental health disorder, and facilities that treated SUDs fell under the jurisdiction of the IMD. The medical understanding and treatment of substance abuse and mental disorders has changed considerably since 1965. However, today’s community-based residential substance use disorders (SUD) treatment providers are still subject to the restrictions of the IMD Exclusion – a single unit of 16-beds or fewer per unique address.  NIDA research on effective treatment in terms of facility or group size can be of great value in illustrating the arbitrary 16-bed limit for facilities receiving Medicaid reimbursement.  Research could also feasibly be conducted on the efficacy of not only group size, but on network size as well, and on the best ratios for practitioners to patients. Marijuana is not only a hot button topic politically, but scientifically as well.  Public policy regarding marijuana continues to be made at a high rate, and too often science does not play a large enough role in the debate.  NIDA needs to make the availability of research findings- both current and past- more visible and readily available.  In addition, because policies are moving so quickly, NIDA must investigate research that can be conducted and disseminated rapidly.  We understand that the scientific process is a deliberate one, and scientific findings should not be compromised because research was conducted hastily. Yet in a situation such as this one, rapid results are a necessity if the science is to play a role in formulating policy, as well as influencing public opinion.  A very high percentage of consumers who utilize substance abuse treatment services suffer from other health disorders as well.  NIDA must continue its work in co-occurring disorders.  The co occurrence of substance abuse and mental health disorders is well documented, and NIDA should continue to collaborate with other institutes in order to develop effective treatment protocols that will allow consumers to be treated for multiple behavioral disorders simultaneously, rather than have their treatment “siloed.” In addition to mental health issues, many of those with substance abuse disorders suffer from a plethora of other health complications.  Often, these consumers first point of contact with any form of health care is treatment for their addiction or abuse.  Yet with the right treatment protocols in place, they can also be treated for other health issues.  NIDA should explore studying how  those who get treated for substance abuse may have difficulty addressing other public health problems, and how those who enter the health care system for a substance abuse disorder can benefit by becoming a healthier person on the whole.While the ultimate goal of many advocates is to treat addiction and substance abuse in health care settings, the reality remains that the criminal justice system remains one of the largest feeders of consumers into treatment.  There is large demand for treatment in both criminal justice settings, such as jails, prisons, and juvenile facilities, as well as post-release.1 out of every 100 U.S. citizens is now behind bars. Approximately 80% have abused drugs or alcohol, and nearly ½ are clinically addicted. The Bureau of Labor Statistics, in its aforementioned evaluation of the substance abuse treatment workforce, focuses very tightly on the criminal justice system: “In recent years, the criminal justice system has recognized that people committing crimes related to drugs are less likely to offend again if they get treatment for addiction. As a result, sentences for drug offenders often include treatment programs. This practice is expected to increase the use of substance abuse treatment programs and the demand for addiction counselors.”   The system does and will certainly need those who are trained not only in criminal justice, but in substance abuse and treatment as well.  Currently, there is only one such credential offered in the United States, which can train a professional in both pursuits; the CCJP offered by the International Certification and Reciprocity Consortium.  There are only 27 states that offer this certification. The professionals who hold this credential receive training in both criminal justice ethics and behavioral health sciences.  Drug offenders account for more than one-third of the growth in state prison population since 1985. Addiction counseling with individuals in the criminal justice system is complex and complicated, and it requires specialized training. Substance abuse or mental health training alone doesn’t really prepare professionals for dealing with the interaction of addictive and criminal thinking.  In addition to addiction counseling skills and theoretical understanding, Criminal Justice Addictions Professionals (CCJP) need an understanding of the criminal justice system and criminal thought patterns. The CCJP credential requires professionals to demonstrate competency through experience, education, supervision, and the passing of a rigorous examination.  Adopted in 2002, the Certified Criminal Justice Addictions Professional is one of the fastest growing credentials in the field of addiction-related behavioral health care. There are now 27 U.S. states and territories that offer a reciprocal CCJP credential. This credential is recognized as the gold standard for competency in the field and has been endorsed by the International Community Corrections Association (ICCA).  This workforce would readily apply any advances by NIDA in the treatment of substance abuse amongst the criminal justice population. We are aware that NIDA conducts research on the criminal justice population. This must continue and expand, as addiction plays a major role in recidivism

Public Health, Format

  • Thank you for asking for input for strategic planning.  I work in prevention and as a treatment engagement specialist. I would like more resources from NIDA devoted to 1)      Helping people see this as a brain disorder and a chronic health issue—such as diabetes or hypertension. 2)      Use the term “flare up” as we would with other chronic health issues, instead of relapse. 3)      Educate parents to identify mental health problems sooner.  How do they know it’s adolescent development or mental illness. I created a simple acronym:    ILL?  Each letter stands for criteria to help determine if the issue with a youth might merit professional help.     I—Intensity. How strong is it?   It’s one thing for a teen to be angry and slam the door, it’s another when a youth punches holes in the wall or you fear for your safety and have to call the police.     L—length of time.  How long as this situation gone on?  It’s one thing for her to cry after the break up with her boyfriend for a few days, it’s another when she is still crying every day 3 weeks or 3 months later.     L—limiting. Is the situation limiting your child’s normal routine?  Is the low mood so bad s/he can’t even go to school?  Has the youth dropped out of the usual interests and activities/work but not replaced them them other positive social connections? This is a simple way to help parents see they can begin to gague if it’s a mental health challenge or teen development.  Thanks

Public Health, Infrastructure

  • Hello,I am writing to comment on the NIDA strategic plan for the next 5 years, focusing on the last 3 sections of the strategic plan. Public Health - Bullet one: Improve the understanding of factors that influence the integration of evidence-based research findings into healthcare policy and practice (implementation science) - I would propose modifying to read "Improve the understanding of factors that influence the integration of and promote the uptake of evidence-based research findings into healthcare policy and practice" The main point of the above change is to emphasize that the goal of implementation science is to promote the uptake of evidence-based research findings and not simply to understand what influences the process. - Bullet three:  Increase strategic partnerships with the community (academia, pharma, biotech, healthcare organizations, policy makers, etc.) to enhance the dissemination of evidence-based research findings into policy and practice - I would propose modifying to read "Increase strategic partnerships with the community... to enhance the relevance of evidence-based research findings and the dissemination of research findings into policy and practice.  The rationale for the above is that a primary critique of evidence-based practices is that they are not relevant for community providers. It is therefore imperative that we partner with community providers to ensure the relevance of our work before simply trying to disseminate it to the community. Science Infrastructure: - In this section, I think that the bullets about training the next generation of scientists or the bullet or improving the mentoring of young scientists could potentially be combined. It also might be worth specifying stating something about the goal of improving the mentoring of early career investigators to improve the conversion of training awards to independent career programs (as the conversion rate from Ks to Rs is consistently disappointing) Unifying themes- In this section, it might be worth explicitly addressing other populations that are often affected by addictions such as prisoners, the homeless, and sexual minorities. As another unifying theme, it might also be worth explicitly addressing the need to prepare healthcare systems and treatment delivery strategies for addicition in light of impending health care reform (via integration into traditional health care settings, for instance). Thank you!

Public Health, Unifying Themes, Infrastructure

  • Below are suggestions to assist the Substance Use Disorder field to follow the NIDA 2016-2020 strategic plan priorities. The suggestions apply equally to all four priorities of Prevention, Interventions, Treatment and Recovery Support Services. Suggested research topics for Prevention, Interventions, Treatment and Recovery Support Services are as follows: a) emerging issues, such as opiates and the changing marijuana environment; b) workforce development; c) research for specific populations including, youth through older adults, ethnic and sexual minority populations, high risk populations, such as pregnant and parenting women, geographic differences in providing services between urban and frontier communities.  Understanding which interventions are most likely to be successful with which population is important and NIDA can lead the way. Continuing to learn and grow in the four areas listed above may help to achieve the NIDA 2016-2020 strategic plan. Our division credits NIDA’s previous work and continued supportive commitment to increase Medication Assisted Treatments, therapies for those with co-occurring conditions, and continue to prioritize identifying innovation strategies to address our nation’s most significant drug issues (not including alcohol); marijuana and opiates. In closing it is critical that NIDA work in collaboration with NIAAA on Alcohol Issues, and CDC on nicotine therapies.

This page was last updated February 2015