Consider new options for treating OUD in designing trials

Abstract

Although there are already three approved medications to treat opioid use disorder (OUD) — methadone, buprenorphine, and naltrexone — “novel treatments” are needed, according to a review published this month in JAMA Psychiatry. Partly because of long‐standing barriers to treatment with methadone and buprenorphine, the review looked at possible treatments that go “beyond the endogenous mu‐opioid receptor [MOR] system. For the review, a public–private partnership including members of the federal Food and Drug Administration (FDA) and the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) group met to look at potential treatments for OUD, including cannabinoids, psychedelics, sedative‐hypnotics and vaccines. The consensus recommendations for clinical trial design included targeting the stage of treatment (e.g., seeking treatment, early abstinence, long‐term recovery), looking at the role of treatment, looking at primary outcomes informed by patient preferences, and considering adverse events, including the potential for relapse or overdose in the case of relapse. The study, “Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder,” is by Brian D. Kulik, Ph.D., and colleagues, and funded by the ACTTION public–private partnership with the FDA.