The following is a summary of “Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder,” published in the November 2022 issue of Psychiatry by Kiluk, et al.

To address the ongoing opioid pandemic and enduring obstacles to current OUD therapies that target the endogenous μ-opioid receptor (MOR) system, novel therapeutics for opioid use disorder (OUD) are required. For a study, researchers sought to highlight distinctive clinical trial design aspects for the investigation of novel OUD therapies that target targets other than the MOR system. 

The US Food and Drug Administration and the public-private partnership Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) sponsored a meeting in November 2019 to discuss the evidence for various OUD treatments, such as marijuana, psychedelics, sedative-hypnotics, and immunotherapeutics like vaccines. In addition, the most important trial design considerations for the evaluation of novel OUD treatments were presented, including consensus recommendations for: the stage of treatment that will be targeted (e.g., seeking treatment, early abstinence/detoxification, long-term recovery); the role of treatment (adjunctive with or independent of existing OUD treatments); the primary outcomes informed by patient preferences that assess opioid use (including changes in patterns of use), treatment, treatment retention, and/or global functioning and quality of life; and adverse events, including the potential for opioid-related relapse or overdose, especially if the patient is not simultaneously taking maintenance MOR agonist or antagonist medications. 

The development, translation, and uptake of efficient and secure therapies for persons dealing with OUD would be accelerated by putting the suggestions made into practice and by taking feedback from those with lived experience into consideration during the design phase.

Reference: jamanetwork.com/journals/jamapsychiatry/article-abstract/2799201