Optimizing the Duration, Retention, and Discontinuation of Medication Treatment for Opioid Use Disorder
The Research Need
Patients who remain on medication treatment for opioid use disorder (OUD) for a longer time tend to have better outcomes. The risk of relapse greatly increases after patients stop taking medication. Retaining patients in treatment remains a challenge, and little is known about when patients can safely stop treatment.
About the Program
This program will test strategies to improve retention in medication-based treatment for OUD as well as strategies to improve outcomes among patients who have been stabilized on OUD medications and want to stop taking medication. The research will also identify patient characteristics associated with relapse after discontinuation and develop a predictive risk model for relapse.
The study will be a two-phase randomized clinical trial:
- The first phase will focus on retention and strategies to reduce dropout rates from medication-based treatment.
- The second phase will examine discontinuation, including assessing how to end medication-based treatment and the role of behavioral interventions.
This will be the first study of medications to treat OUD to prospectively follow a large sample of patients through discontinuation. The findings will help researchers better understand which factors predict relapse as opposed to stable recovery in patients not taking medication, and develop tools to assess those factors in patients.
Researchers will evaluate both pharmacological and behavioral treatment approaches that are intended to be practical and feasible. If these strategies are effective, they could be widely and sustainably disseminated and could reduce the public health impact of OUD by improving the delivery of medication for OUD.
To date, through the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, NIH has awarded approximately $62.3 million to three institutions to conduct a clinical trial on optimizing retention, duration, and discontinuation strategies for medication treatment for OUD.
This research will be carried out through the National Drug Abuse Treatment Clinical Trials Network (CTN), which unites medical and specialty treatment providers, researchers, patients, and the National Institute on Drug Abuse.
The CTN supports rigorous, multisite clinical trials to determine the effectiveness of treatment strategies in a broad range of treatment settings and diverse patient populations, and to ensure the timely transfer of research results to clinicians, providers and their patients.
The expansion of the CTN, supported by the NIH HEAL Initiative, enhances the network’s scientific and clinical research capabilities and allows increased coverage in geographic regions most affected by the opioid overdose epidemic.
The program will carry out a pragmatic effectiveness trial that will enroll patients at approximately 20 sites, including both primary care and addiction specialty care settings. It will include sub-studies on medication retention and medication discontinuation.
The clinical trial will:
- Test pharmacologic and behavioral strategies to improve OUD pharmacotherapy treatment retention and to improve outcomes among patients who have stabilized on OUD medications and want to stop medication.
- Identify predictors of successful outcomes and develop a stage model of relapse risk.
- Emmes Corporation – Maryland
- McLean Hospital – Massachusetts
- New York University School of Medicine – New York