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Listening to Patients’ Voices in Developing New Opioid Addiction Treatments

April 05, 2018

What Patients are Saying on a blackboard

One of the pillars of the current federal initiatives to end the opioid crisis is the development of new medications to treat opioid addiction. Currently we have three approved drugs—methadone, buprenorphine, and naltrexone—in a growing number of formulations, including some that are extended-release (long acting). But not all patients respond to the existing medications, and each patient has unique needs. With other chronic conditions such as hypertension or diabetes, there is a vastly wider array of treatment options that can be tailored to individual circumstances, and we need the same wide array of options in treating addiction.

Until now, a single criterion has been used as the test of a new opioid addiction medication during the drug development and FDA approval process: whether it can produce sustained abstinence in study participants compared to placebo. But there is growing concern that this may be too stringent a measure: If a patient reports meaningful improvement in functioning even with reduced use of illicit opioids, or if gains in specific areas of life and health such as sleep quality can improve a patient’s condition, shouldn’t these other criteria also be used to assess the value of a new treatment? In the latest issue of Science Translational Medicine, I joined colleagues from NIDA and FDA to make a case for alternative clinical endpoints—other than abstinence—that can be used to develop new treatments for addiction.

Importantly, patients themselves should have a voice in determining what outcome measures are important to them. Often, physicians and researchers do not know which symptoms are most troubling or what patients would prioritize in terms of beneficial outcomes. Thus, there is a move to involve patients in the process of discovering new therapies.

The FDA Patient-Focused Drug Development Initiative (PFDD), established in 2012, seeks to solicit patient perspectives on which symptoms are most important to target and how to measure meaningful improvement in those symptoms, based on how their disease impacts functioning and quality of life.

The pharmaceutical industry has also encouraged patient input in drug development, because it benefits them as well. Creating treatments that better address patients’ needs increases the likelihood that they will adhere to their treatments. This in turn provides an incentive for industry to invest resources in research and development rather than risk putting money into a medication that won’t be used.

On April 17, FDA, in collaboration with NIDA, is conducting a public meeting on patient-focused drug development for Opioid Use Disorder (OUD) to gain first-hand accounts from those with OUD. The objective of this meeting is to learn about patients’ experiences with current treatments as well as their experiences with medications to reverse overdose. It will be a unique opportunity for patients’ voices to be heard and have an impact in what kinds of treatments will be developed for opioid addiction in years to come.

This week at the National Rx Drug Abuse and Heroin Summit, NIH Director Francis Collins announced a near-doubling of funds to address the opioid crisis as part of the HEAL (Helping to End Addiction Long-term) initiative. Besides money, it will take creative in- and out- of-the-box thinking, as well as a coordinated “all hands on deck” approach to solve the crisis. And those hands shouldn’t be limited to the scientific and research world. Patients suffering from opioid addiction can have an active role in the development of new treatments for their disorder, and families of individuals with addiction can provide a valuable perspective as well.

For more information on the April 17th meeting at FDA, and how to participate remotely or in person, please register.

This page was last updated April 2018

Comments

listening to our clients/patients

as a BHC clinician of over 40 years, indeed it is so very important for a collaborative effort between client and clinician to negotiate personalized outcomes.The therapeutic alliance + client strengths and resources account for 85% of the + benefit that clients derive from care.
Rich, MSW

An ounce of prevention is worth a pound of cure.

I took prescribed opioids several times in the 90s & over the past 7 years. At no time did anyone tell me the dangers of opioids.

I was frustrated that I was in debilitating pain & had to drive to my doctor's office every 15 days to pick up a new prescription. That was downright stupid, in fact. I shouldn't have been driving.

I did research & asked my dr about the possibility of addiction in the 90s. Tell people the risks. My PCP has a written statement that patients must read & sign.

I have much to say on this subject: How I made it through suicidal thoughts; & how I made it through withdrawal a dozen times. But space is limited.

Medication-assisted treatment

In Canada, a national guideline was released recommending buprenorphine/naloxone as first line treatment for opioid use disorder. Methadone was considered second line treatment. Long-acting naltrexone was not recommended at all.
Perhaps it would be helpful for patients and physicians to know more about management of OUD in countries like Canada, Australia, France and Great Britain.

benefits to the pharmaceutical industry

"The pharmaceutical industry has... encouraged patient input in drug development, because it benefits them as well." This is sometimes true, and sometimes not true. The pharmaceutical industry benefits from the sale of any drug, for example, that results in dependence, even if there is no societal or personal gain. This was a major factor in how the opioid problem developed in the first place. Big pharma does NOT have our interests in mind; they have their interests in mind. Sometimes their interests intersect with ours, and sometimes they oppose ours. Caution is advised.

Find Help Near You

The following website can help you find substance abuse or other mental health services in your area: www.samhsa.gov/Treatment. If you are in an emergency situation, people at this toll-free, 24-hour hotline can help you get through this difficult time: 1-800-273-TALK. Or click on: www.suicidepreventionlifeline.orgExternal link, please review our disclaimer.. We also have step by step guides on what to do to help yourself, a friend or a family member on our Treatment page.

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    NIDA. (2018, April 5). Listening to Patients’ Voices in Developing New Opioid Addiction Treatments. Retrieved from https://www.drugabuse.gov/about-nida/noras-blog/2018/04/listening-to-patients-voices-in-developing-new-opioid-addiction-treatments

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    Dr. Nora Volkow: Video Highlights

    NIDA Director, Dr. Nora D. Volkow Videos

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    • Kentucky Educational Television, May 2016
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    • TEDMED, January 2015
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    • The World Science Festival, April 2014
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    • Rockburn Presents, November 2012
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    • Brookhaven National Laboratory WBNL Video, October 2012
      Chemistry celebration: FDG: Contribution to Our Understanding of Addiction
    • CBS 60 Minutes, April 2012
      Hooked: Why Bad Habits Are Hard to Break 
    • Science Times, June 2011
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