May 7-8, 2013
The National Advisory Council on Drug Abuse convened its 114th meeting at 2:30 p.m. on May 7, 2013 in Conference Room C, 6001 Executive Boulevard, Bethesda, Maryland. Dr. David Shurtleff, Acting Deputy Director, NIDA, chaired the meeting for Nora D. Volkow, M.D., Director, NIDA. The closed portion of the meeting on May 7, 2013, was for the purpose of reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. The open portion, which was open to the public on May 8, 2013, began at 8:30 a.m. The Council adjourned on May 8, 2013 at 1:00 p.m.
Council Members Present
Regina Carelli, Ph.D.
Nabila El-Bassel, Ph.D., D.S.W.
Carl Hart, Ph.D.
James Hildreth, Ph.D., M.D.
Elizabeth Howell, M.D.
Terry Jernigan, Ph.D.
Thomas Kirk, Ph.D.
Robert Lenox, M.D.
Kelvin Lim, M.D.
Barbara Mason, Ph.D.
Linda Mayes, M.D.
Michael Nader, Ph.D.
Marina Picciotto, Ph.D.
John Rotrosen, M.D.
Jon-Kar Zubieta, Ph.D., M.D.
David Shurtleff, Ph.D., Acting
Mark Swieter, Ph.D., Acting
Federal Employees Present
Jane Acri, Ph.D.
Tom Aigner, Ph.D.
Will M. Aklin, Ph.D.
Nathan Appel, Ph.D.
Albert Avila, Ph.D.
Beth Babecki, M.A.
Oluyomi Bakare (Okunola), Ph.D.
Jamie Biswas, Ph.D.
James Bjork, Ph.D.
Ericka Boone, Ph.D.
Kris Bough, Ph.D.
Cheryl Boyce, Ph.D.
Jasmine Carpenter, Pharm.D.
Jessica Chambers, Ph.D.
Naresh Chand, DVM, Ph.D.
Scott Chen, Ph.D.
Nora Chiang, Ph.D.
Joseph Collins, Ph.D.
Wilson Compton, M.D., M.P.E.
Glenda Conroy, C.P.A.
Kevin Conway, Ph.D.
Carol Cushing, RN
Augusto Diana, Ph.D.
Genevieve deAlmeida, Ph.D.
Bethany Griffin Deeds, Ph.D.
Tony Dekker, D.O.
Marta DeSantis, Ph.D.
Richard Denisco, M.D.
Augusto Diana, Ph.D.
Gaya Dowling, Ph.D.
Lori Ducharme, Ph.D.
Sarah Duffy, Ph.D.
Lynda Erinoff, Ph.D.
Rene Etcheberrigaray, M.D.
Matthew Finger, M.A.
Jerry Frankenheim, Ph.D.
Joseph Frascella, Ph.D.
Mimi Ghim, Ph.D.
Udi Ghitza, Ph.D.
Meyer Glantz, Ph.D.
Harold Gordon, Ph.D.
Debra Grossman, M.A.
Shwe Gyaw, Ph.D.
Diana Haikalis, M.B.A.
Aidan Hampson, Ph.D.
Peter Hartsock, Ph.D.
Paul Hillery, Ph.D.
ichard Jenkins, Ph.D.
Dionne Jones, Ph.D.
Meena Karithanom, M.P.H.
Mary Kautz, Ph.D.
Andrew Kessler, J.D.
Jagjitsingh Khalsa, Ph.D.
Elena Koustova, Ph.D.
Carol Krause, M.A.
Elizabeth Lambert, M.Sc.
Story Landis, Ph.D.
Diane Lawrence, Ph.D.
Eliane Lazar-Wesley, Ph.D.
Jacqueline Lloyd, Ph.D.
Minna Liang, Ph.D.
Woody Lin, Ph.D., M.D.
Marsha Lopez, Ph.D.
Minda Lynch, Ph.D.
Raul Mandler, M.D.
Christine Melchior, Ph.D.
Gerald McLaughlin, Ph.D.
Mary Ellen Michel, Ph.D.
Ivan Montoya, M.D.
Goeffrey K. Mumford, Ph.D.
Jacques Normand, Ph.D.
Samia Noursi, Ph.D.
Stephanie Older, J.D.
Lisa Onken, Ph.D.
Moo Kwang Park, Ph.D.
Harold Perl, Ph.D.
Nancy Pilotte, Ph.D.
Denise Pintello, Ph.D.
Vishnudutt Purohit, Ph.D.
Rao Rapaka, Ph.D.
Nadine Rogers, Ph.D.
Carmen Rosa, M.S.
Joni Rutter, Ph.D.
Cathrine Sasek, Ph.D.
John Satterlee, Ph.D.
Paul Schnur, Ph.D.
Ming Shih, Ph.D.
Mariela Shirley, Ph.D.
David Shurtleff, Ph.D.
Belinda Sims, Ph.D.
Hari Singh, Ph.D.
Karen Sirocco, Ph.D.
Phil Skolnick, Ph.D., D. Sc.
Steven Sparenborg, Ph.D.
Geetha Subramaniam, M.D.
Jack Stein, Ph.D.
Michele Straus, M.S.
Karyl Swartz, Ph.D.
Mark Swieter, Ph.D.
Betty Tai, Ph.D.
Barbara Usher, Ph.D.
Susan Volman, Ph.D.
Kevin Walton, Ph.D.
Eric Wargo, Ph.D.
Naimah Weinberg, M.D.
Cora Lee Wetherington, Ph.D.
David White, Ph.D.
Tisha Wiley, Ph.D.
Da-Yu Wu, Ph.D.
Members of the Public Present
Susan Awad - American Society of Addiction on Medication
Rebecca Cohen - Synergy Enterprises, Incorporated
Yoshie Davison, M.S.W. - American Academy of Child and Adolescent Psychiatry (AACAP)
Roberto Fernandez, M.P.H. - American Association of Colleges of Osteopathic Medicine (AACOM)
Nancy Holmes, M.S. - BLH Technologies, Incorporated
Katia Howlett, Ph.D. - Synergy Enterprises, Inc.
Andrew Kessler, J.D. - International Certification & Reciprocity Consortium (IC & RC)
John Magnuson - National Council on Alcoholism and Drug Dependence (NCADD)
Penny Mills, M.B.A. - American Society of Addiction Medicine (ASAM)
Kodilichi Nwankwo, Pharm.D.
Lori Pellnitz, M.A. - SRI International
Emily Smith, M.P.H. - RTI International
Roy Walker - Synergy Enterprises, Incorporated
Evelyn Yang, Ph.D. - Community Anti-Drug Coalitions of America
Patrick Zickler - Synergy Enterprises, Incorporated
Closed Portion of the Meeting – May 7, 2013
Call to Order
This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
Dr. David Shurtleff, Acting Director, NIDA, called the meeting to order and welcomed the Council and staff in the absence of Dr. Nora Volkow, Director, NIDA. He reminded those present that the Federal Advisory Committee Act applies to Council meetings and that this portion of the meeting was closed to the public.
Dr. Mark Swieter, Acting Executive Secretary, summarized relevant NIH policies, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies.
In turn, the Director or a designee for the Division of Clinical Neuroscience and Behavioral Research, Division of Epidemiology, Services and Prevention Research; the Division of Pharmacotherapies and Medical Consequences of Drug Abuse and the Division of Basic Neuroscience and Behavioral Research presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc. Council also approved three administrative supplements. Relevant applications were presented to Council for Special Council Review, and Council agreed with program assessments. All Trans-NIH Initiatives, i.e., Blueprint and Roadmap applications and NIDA Secondary applications Council also provided concurrence.
Members must absent themselves from the Council meetings during discussion of, and voting on, individual applications from their own institutions or other applications in which there is a conflict of interest, real or apparent. Conflicts of interest statements were signed by each member of the Council. Members were not required to leave if an application in conflict with that member was acted upon en bloc.
Open Portion of the Meeting – May 8, 2013
Call to Order
Dr. David Shurtleff, Acting Director, NIDA, called the open portion of the meeting to order in the absence of Dr. Nora Volkow, Director, NIDA. He reminded the Council and audience that the meeting was open to the public in compliance with the Government in the Sunshine Act and indicated that time would be provided for public comment. Dr. Shurtleff called attention to future Council meetings: September 4, 2013, February 4-5, 2014 and May 6-7, 2014.
Consideration of the Minutes of Council
The Minutes of the February 2013 meeting were approved as written.
NIDA Director’s Report - David Shurtleff, Ph.D., Acting Director, NIDA
Dr. Shurtleff began the report by indicating that he would present on behalf of Dr. Volkow and announced that he would be leaving NIDA in June, 2013 to take on the role of Deputy Director at the National Center for Complementary and Alternative Medicine (NCCAM). He named several areas opportunities for collaboration between NIDA and NCCAM, including pain management, placebo effect, and treatment introduction into primary care. He also announced the recent retirement of Dr. Teri Levitin, the Director of NIDA’s Office of Extramural Affairs (OEA) and the appointment of Dr. Mark Swieter as Acting Director of NIDA OEA.
Dr. Shurtleff then turned to the 2013 NIDA budget, noting that it was only recently approved by the Office of Management and Budget and includes a $60 million dollar reduction from the 2012 budget duet to sequestration. This will mean some reductions in funding for non-competing grants and difficult decisions for new projects. The 2014 NIDA budget process and level remain uncertain, but the budget is likely to remain near one billion dollars. Difficult budget challenges are likely to continue.
He then provided an update of efforts underway toward a functional integration of NIDA and NIAAA and, to a lesser extent, NCI. A Functional Integration Coordinating Committee has been set up that includes representatives of NIDA, NIAAA and NCI. FY13 initiatives that contribute to functional integration include Funding Opportunity Announcements (FOA) on prevention and health promotion interventions to combat alcohol and other drug abuse in the military, research on comparative effectiveness and implementation of HIV/AIDS and alcohol interventions, and mechanisms of alcohol and nicotine co-addiction.
Other FOAs in which NIDA is participating include NIH Pain Consortium Program Announcements and NIH Common Fund initiatives. The latter efforts are aimed at increasing the diversity of the biomedical workforce by way of training, building infrastructure, and establishing a mentoring network.
Dr. Shurtleff next spoke about recent activities and events at NIDA. Among new NIDA FOAs, an RFA have been published related to substance use disorders and molecular regulation of brain energy utilization changes due to chronic use of abused substances. In another area of interest, marijuana use has increased, and is now the most commonly used illicit drug in the U.S. and many other countries, notably now more common than cigarette use among 12th grade students according to the 2012 Monitoring the Future Study. NIDA has developed an FOA for research on the social, behavioral and public health impacts of recent marijuana legalization laws and policies in several states in the US. In addition, a meeting of NIDA staff will be convened to help identify types of cannabis research now supported, the most urgent research questions, how to address these questions, and which other organizations to partner with.
Priority areas for NIDA have remained similar for a number of years, and include prevention research, treatment interventions, and the interwoven epidemic of HIV/AIDS and drug addiction. Research has implicated the prefrontal cortex in driving compulsive behavior, and the identification of drugs for treatment remains a NIDA priority. Buspirone has shown promise for cocaine and nicotine self-administration and follow-up studies are in progress. Cocaine hydrolases, once considered promising for treatment only in emergency overdose cases, has been shown to have ongoing activity and follow-up preliminary clinical trials to explore more general use of this strategy are being developed. To shorten the timeline for the development of these and other medications, a new Medications Development Centers of Excellence Cooperative Program FOA has been released; it uses the U54 cooperative agreement mechanism that calls for close work with NIDA staff.
To address the rising problem of prescription drug abuse (especially opiates), a new NIDA FOA using SBIR and STTR mechanisms will address ways to counteract prescription drug diversion and abuse. For these and other initiatives, NIDA is collaborating with a number of stakeholders at local, state and federal levels as well as with additional public/private organizations, since effective approaches will require comprehensive, well considered strategies.
Another new FOA is the Advancing Exceptional Research award to address drug abuse and HIV. Its first three awards are to Julio Montaner involving Seek, Test and Treat. Jerome Groopman will continue his Avant Garde research on novel strategies to antagonize both cocaine and HIV pathology. Phillip Berman will investigate enhanced HIV antibody response in HIV and HCV seropositive women. A new RFA to support highly innovative R01 applications on HIV/AIDS has also been released to complement the HIV/AIDS Avant-Garde Award Program.
Dr. Shurtleff concluded his report by describing current outreach efforts by NIDA staff. NIDA and the Friends of NIDA have testified at a Capitol Hill briefing about military personnel, veterans and their families and how substance abuse research is effecting positive change. NIDA is also organizing a scientific program at the American Psychiatric Association, which includes the well-received Addiction Performance Project.
Council members thanked Dr. Shurtleff for his presentation. Questions and discussion centered around the relative roles of medications vs non-pharmacological mechanisms or techniques in treating substance abuse and addiction, functional integration and the effects of sequestration on NIDA’s ability to fund grants, and on marijuana as a contentious sociocultural and rights issue. Council emphasized the important role NIDA should play in providing data to inform and increase public health awareness of the effects and consequences of marijuana physiologically, behaviorally and socioeconomically.
Pain Consortium Update - Story Landis, Ph.D., Director, National Institute of Neurological Disorders and Stroke, NIH
Dr. Story Landis, Director of the National Institute on Neurological Disorders and Stroke (NINDS) since 2003, presented an update on the NIH Pain Consortium. The Consortium was established by then NIH Director, Dr. Harold Varmus, in 1996 but lacked clear goals, dedicated staff, portfolio and dedicated funding. The Pain Consortium was revitalized by the subsequent NIH Director, Dr. Elias Zerhouni, in 2003 with the mission to enhance pain research and promote collaboration across NIH ICs with related programs and activities, with Leadership from NINDS, NCCAM, NINR, NIDCR and NIDA Directors; Dr. Landis is Chair of the NIH Pain Consortium.
Dr. Landis reported that pain portfolio analysis in 2011 showed 52% of the projects were clinical research, 35% basic research, and 13% translational research, which represents a gap area. Centers of Excellence in pain education were established in multiple universities, with NIDA as the lead IC. A Pain Registry has been started at Stanford University and is expected to be fully rolled out in 2014 with NIDA as lead Institute. Recent symposia, workshops, publications and expert panels have been organized to address issues regarding chronic pain, back pain, pain and opioids, and vulvodynia.
She indicated that NINDS has helped to identify and promote uniform formats for clinical data collection, analysis and sharing. A number of large FOAs, notably the NIH Blueprint’s Human Connectome Project on brain imaging, and a Blueprint initiative to examine the acute to chronic pain transition, the NIH Collaboratory, and the Centers of Excellence in Pain Education were initiated by the Pain Consortium.
Recent projects include epigenetic contributors to persistent neuropathic pain, glial priming and pain, neuroimmune response to injury and pain, and emotional and motivational learning circuits and pain. The Pain Consortium Website includes posting of current FOAs related to pain. Despite the lack of dedicated funds, the size of the pain portfolio at NIH has continued to grow since 2003.
Dr. Landis then spoke about the Patient Protection and Affordable Care Act of 2010, which includes several provisions related to patient reimbursement and care that relate to pain. The Act also specified that the Institute of Medicine develop a report on pain; this IOM report “Pain in America’ has become an important guide for pain researchers and advocates. The Act also specified that a coordinating committee with representation from federal agencies, patient advocacy groups and scientists to look at a number of aspects of pain, a summary of advances, critical gaps, recommendations to reduce duplication, how to disseminate information on pain care, and recommendations on how to expand public/private partnerships. Dr. Landis is chair of this committee, and its portfolio analysis indicates that, among federal agencies, NIH is supporting the majority of pain research. A future priority is the development of a population based strategy for dealing with prevention and education regarding pain.
Council thanked Dr. Landis for an enlightening presentation. Discussion included how to categorize types of pain and different underlying mechanisms, research gaps including pediatric pain, and the laudatory approach of allowing institutions not initially chosen as Centers of Excellence in Pain Education to participate in the pain curriculum development effort.
CTN Update - Betty Tai, Ph.D., Director, Center for Clinical Trials Network, NIDA
Dr. Tai began her presentation with a brief history of the Clinical Trials Network (CTN), whose goals and priorities were realigned with the arrival of Dr. Nora Volkow to revive medical involvement in treating substance use disorders, to increase translational efforts to move research findings into practice, and to enhance the use of the CTN as a platform for additional types of research and training. Dr. Tai explained that current clinical trials undertaken by the CTN may be broadly grouped into several categories. Efficacy/effectiveness studies and comparative effectiveness studies involve pharmacotherapy trials and include cocaine use reduction with buprenorphine, relapse prevention by buspirone for cocaine dependence, cannabis cessation with N-acetylcysteine, treatment of methamphetamine dependence with extended release depot naltrexone and buproprion, comparing extended release depot naltrexone versus buprenorphine for opioid treatment, and comparing extended release depot naltrexone and buproprion versus placebo for methamphetamine dependence.
A third broad category of CTN trials is adjunctive treatments for SUD specialty care providers, which includes stimulant reduction intervention using dosed exercise, web-based delivery of evidence-based psychosocial treatment for substance use disorders, and smoking cessation and stimulant treatment. A fourth broad category is HIV studies and includes using hospital visits as opportunities for prevention and engagement for HIV-infected drug users, comparing treatments for HIV-infected opioid and alcohol users in an integrated care effectiveness study, testing linkage to HIV care in China, and HIV rapid testing and counseling in STD clinics in the US. A final broad category is long-term follow-up studies, which include a follow-up of the prescription opioid addiction treatment study and the starting treatment with agonist replacement therapies study.
Dr. Tai next reported that a focus for treatment research in the CTN in the future will be treating addiction by following a chronic care model with continued care maintained that is tailored to the disease severity and the substance used. Recent legislation that has aided in moving toward this goal includes the Mental Health Parity and Addiction Act in 2008, the Children’s Health Insurance Program Reauthorization Act in 2009, and the Patient Protection and Affordable Care Act of 2010. Together these laws will help drive treatment of substance use disorders to primary care settings for initial identification and treatment, support a chronic care model for all diseases, and require outcome measures in a recovery/relapse disease model as opposed to an episodic care model.
Council thanked Dr. Tai for her informative presentation. Discussion was about the availability and importance of the CTN to serve as a platform for involving and training more junior investigators, including investigators from under-represented ethnic/minority groups.
AIDS Avant-Garde Program Update - Jacques Normand, Ph.D., Director, AIDS Research Program, Office of the Director, NIDA
Dr. Normand began his presentation by pointing out that the Avant-Garde program has been in place for five years and has been very successful in recruiting investigators who are new to NIDA. The program was designed to mimic the NIH Pioneer program by focusing on the scientist and his/her track record of exceptional creativity and high-impact research rather than on a given research project. Between 2008 and 2012, NIDA granted 12 Avant-Garde awards. Awardees and their research have been Dr. Julio Montaner studying the Seek and Test for optimal outcomes and prevention in HIV and AIDS in injecting drug users; Dr. Jerome Groopman studying inhibition of HIV at the immune synapse utilizing novel ligands and receptors; Dr. Ileana Cristea using proteomic tools to uncover the role of chromatin remodeling in HIV-1 infection; Dr. Rafick-Pierre Sekaly with novel concepts for the eradication of HIV, Dr. Jonathan Karn manipulating epigenetic control mechanisms to control HIV transcription; Dr. Dana Gabuzda examining systems biology of immune reconstruction in HIV/AIDS; Dr. Benjamin Chen imaging viralogical synapses during parenteral HIV transmission; Dr. Eric Verdin working with a novel model for HIV latency in primary memory T cells; Dr. David Ho testing monthly antiretroviral therapy using multispecific HIV neutralizing antibodies; Dr. Jeremy Luban identifying human genes that influence HIV-1 replication, pathogenesis, and immunity in intravenous drug users; Dr. Samuel Friedman working on preventing HIV transmission by recently-infected drug users; and Dr. David Smith using molecular epidemiology for HIV prevention for drug users and other risk groups.
An additional four Avant-Garde awards were made in 2013. The researchers and their work are Dr. Timothy Cardozo who is working on a combined cocaine and HIV vaccine to elicit HIV-protective antibodies; Dr. Warner Greene of UCSF who is studying the use of caspase-1 inhibitors to reduce or eliminate immunodeficiency that accompanies HIV infections; Dr. Richard Sutton of Yale who is working to identify host genetic factors responsible for host control of HIV in individuals whose immune systems are controlling HIV infection; and Dr. Leor Weinberger of UCSF whose research is aimed at developing novel therapies to automatically target high-risk infectious superspreaders to reduce HIV viral transmission. Dr. Normand went on to explain that because of the success of the Avant-Garde program and because the awards are limited to a single five year period, a complimentary grant award program named Advancing Exceptional Research on HIV/AIDS was developed at NIDA. Like the Avant-Garde awards, these will be focused on supporting creative and innovative research likely to have a high impact on HIV and drug abuse. The awards use the R01 mechanism and are not limited to a single five year project period; although a specific research plan and preliminary data are required. Three of these grants were made in 2013 and two of them went to former Avant-Garde awardees, Drs. Julio Montaner and Jerome Groopman. The third award went to Dr. Phillip Berman of UC Santa Cruz, who will attempt to replicate the protective immune response observed in a rare group of African American women who have developed effective immune responses to HIV, and to identify vaccine immunogens based on ancestral reconstruction of the Env gene sequences from these elite neutralizers.
Council thanked Dr. Normand for his presentation.
Update on Nicotine & Schizophrenia Meeting - Lisa Onken, Ph.D., Chief, Behavioral and Integrative Treatment Branch, Division of Clinical Neuroscience and Behavioral Research, NIDA
Dr. Onken described a workshop on improving smoking cessation treatment for people with schizophrenia, a collaborative effort with NIDA, NCI and NIMH. Smoking and mental illness are also priorities at the CDC and SAMHSA as well as with the HHS Tobacco Control Implementation Steering Committee. Populations with schizophrenia have a high prevalence of smoking, low cessation rates, and significant morbidity and mortality yet are typically excluded from smoking cessation trails, and relapse is common using standard smoking cessation treatments.
She then explained that the workshop gathered experts in both smoking cessation and schizophrenia to review the current state of the field and to identify research gaps, opportunities and new directions. There were workshop panels on medications, behavioral treatments, putative mechanisms underlying treatments, and integrating cessation interventions within larger systems of care.
Dr. Onken next described meeting highlights, including a clinical practice recommendation that the interventions identified as effective in the 2008 update to the PHS Clinical Practice Guideline for Treating Tobacco Use and Dependence should be used by all individuals who use tobacco, including those with psychiatric disorders. Regarding behavioral treatments, contingency management, with and without bupropion, is effective in short-term reductions of smoking in people with schizophrenia. Additionally, cognitive behavioral therapy plus extended duration pharmacotherapy substantially reduces relapse in this population. A web-based motivational decision support system and a behavioral group intervention are under development. Task persistence is somewhat compromised in people with schizophrenia, targeting task persistence may help smoking cessation in this population.
Cognitive remediation is another potential future direction, Dr. Onken further explained, since cognitive deficits are fundamental to schizophrenia and neurocognitive function predicts response to behavioral treatments for schizophrenia; patients who smoke may do so in part to alleviate cognitive symptoms. Working memory is a major deficit correlated with schizophrenia that worsens with abstinence and this deficit is a barrier to cessation. Varenicline attenuates abstinence-induced deficits in working memory, may reduce psychosis, and is safe, well-tolerated and an effective smoking cessation pharmacotherapy.
Dopamine depletion is also correlated with schizophrenia and comorbid addiction, with negative symptoms inversely related to dopamine levels in the ventral striatum, and treatments to address the loss of dopamine may also address symptoms including cognitive deficits. Dr. Onken then presented highlights about nicotine and nicotine receptors. It is uncertain why nicotine is not a helpful neurocognitive drug for people who smoke, despite its positive cognitive effects in people with schizophrenia who do not smoke. Alpha-7 nicotinic receptor deficits are observed with schizophrenia, requiring higher doses of nicotine to activate receptors. Clozapine directly stimulates these receptors and decreases smoking. Alpha-7 nicotinic agonists have positive effects on neurocognition in schizophrenia and may alter smoking behavior.
Workshop consensus research recommendations included the dissemination and adoption of research findings regarding existing interventions for smoking cessation. Research to develop improved behavioral and pharmacological treatments should examine the putative mechanisms of nicotine additions of nicotine addiction in people with schizophrenia, and on hypothesized molecular and behavioral targets of behavioral change. The proposed next steps include continued collaboration with NIMH and NCI, and encouraging research in this area.
Council thanked Dr. Onken for her presentation. There was discussion of activation of the alpha 7 nicotinic receptor, the need for medications targeted to smoking cessation to be developed for people with schizophrenia, and the need to look at already existing medications for smoking cessation for their efficacy and effectiveness in those with schizophrenia.
Prescription Drug Abuse: National Strategies and Plans - Wilson Compton, M.D., M.P.E., Director, Division of Epidemiology, Services, and Prevention Research, NIDA
Dr. Compton began his presentation describing prescription drug abuse as a major public health problem in the US that remains a major priority for NIDA. The source of the drugs is often family and friends, interventions can be effective, both primary prevention and targeting overdose or addiction, clinician education is essential and there are many research needs. Data from 2011 showed that roughly 6 million Americans 12 years of age and older abused one or more types of prescription drugs in any given month. Between 2002 and 2011, there was a doubling of cases of individuals seeking care for opioid issues related to analgesic abuse. There has also been an increase in the number of individuals infected with Hepatitis C as a consequence of prescription opiate abusers shifting to heroin and injection drug use.
Dr. Compton further explained that since 2009, there have been more drug overdose deaths than motor vehicle deaths in the USA, about 38,000 in 2010, with opioids the most-associated drug type and the one with greatest rate of increase. The use trend mimics the frequency of opioid sales and prescriptions since 1999. Dentists and emergency medicine physicians were the main prescribers for patients 5-29 years old. The regional distribution of overdoses has progressed, also somewhat mimicking each state’s number of opioid prescriptions. Dr. Compton next noted that there is a need to develop medications with lower abuse potential, slower release, and formulations to reduce abuse liability. Prevention may include public education, overdose intervention e.g. nasal Naloxone for opioid overdose; minimizing diversion; and clinicians need to know the prescriptions given to patients, which is accessible through a prescription drug monitoring program.
Dr. Compton then pointed out that education of physicians about treating pain and the powerful medications used for it is quite low. Pain treatment education in medical schools is only a median 7 hours in US medical schools, versus 14 hours in Canada and 75 hours for veterinarians. Efforts are under way to effect change. Centers of Excellence in Pain Education, funded by NIH Pain Consortium, are developing related training programs. NIDAMED offers a quick screen for clinicians in general medical settings, as well as an interactive teaching video. Continuing medical education is also available through NIDAMED.
Dr. Compton spoke of future efforts. Treatment of persons with addiction is key. Policy and regulatory approaches, clinical education, and practice-based research are needed. To address misuse, patient and clinician education and safer approaches to abuse resistance, including research and practice developments, are essential. Balancing between the benefits of properly used opioid, sedative and stimulant medications, relative to risks, will be critical and complicated.
Council thanked Dr. Compton for his informative presentation. There was discussion of the increase in number of people initially abusing prescription opiates switching to heroin, the primary use of behavioral therapy as opposed to pharmacotherapy to treat opiate addiction, treatment of individuals with prescription opiate dependence needing treatment for pain, and the relationship between suicidality and the increase in opiate overdoses.
Concept Clearances - Wilson Compton, M.D., M.P.E. Director, Division of Epidemiology, Services, and Prevention Research, NIDA; and Elena Koustova, Ph.D., M.B.A., Director, Office of Translational Initiatives and Program Innovations, Office of the Director, NIDA
Five new program concepts were presented to Council. Dr. Wilson Compton, Director, DESPR presented four concepts related to HIV/AIDS and substance abuse. The first one involved integrating substance use treatment and HIV prevention within HIV service delivery systems. The aim is to address the finding that people who either currently are or have a history of injection drug use are much less likely to be prescribed anti-retroviral treatment regardless of the severity of their HIV serostatus. The second concept aimed to get a better understanding through basic, epidemiologic, prevention and services research of the intersection between substance use and HIV/AIDS in black/African Americans. Although black/African Americans constitute one third of the US population, they account for nearly half the new HIV diagnoses in the US. The third concept was focused on the homeless and unstably housed, who have high rates of HIV and substance abuse and for whom service delivery is complicated. For many, mental health is an additional issue. The goal is to reduce morbidity and mortality. The fourth concept proposed to examine the intersection of HIV, substance abuse and chronic pain in older Americans. The CDC estimates that within a couple of years, most people living with HIV in the US will be over 50 years of age.
Council expressed appreciation for NIDA’s pursuit of issues raised in previous Council meetings and commended NIDA’s approaches in these initiatives, particularly in prevention and services delivery research.
The last concept was presented by Dr. Elena Koustova, Director, Office of Translational Initiatives and Program Innovations at NIDA. She spoke about an initiative to involve small businesses in the development of abuse resistant formulations and devices to avoid diversion of prescription opioids by patients. This follows recently issued draft guidance from the FDA to assist businesses in developing these types of drugs with abuse deterrent properties. It would directly contribute to execution of the 2011 Office of National Drug Control Policy Prescription Drug Control Plan that specifically charges NIH with expediting through research grants the development of abuse resistant formulations.
Council agreed that this was a timely and important topic that is clearly needed.
There were no Public Comments
The 114th meeting of the National Advisory Council on Drug Abuse was adjourned at 1:00 p.m.
I hereby certify that the foregoing minutes are accurate and complete.
Nora D. Volkow, M.D.
National Advisory Council on Drug Abuse
Mark Swieter, Ph.D.
Executive Secretary, Acting
National Advisory Council on Drug Abuse
Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.