A clinical research study is investigating whether tirzepatide, used as an adjunct to buprenorphine, can improve outcomes for individuals with opioid use disorder (OUD). According to information from ClinicalTrials.gov, the Phase 2 trial focuses on measuring retention in treatment, substance use, and sleep quality.
The randomized, placebo-controlled trial is designed to evaluate the impact of tirzepatide compared to a placebo. Participants will be randomized in a 1:1 ratio to receive either tirzepatide or a placebo, with dosing consistent with current prescribing guidelines. Participants will receive weekly subcutaneous injections and attend research visits through 26 weeks post-randomization, with a final safety follow-up at week 30. To measure sleep quality, participants will be provided with a Fitbit Charge 6 device.
Primary research objectives include assessing 6-month retention in buprenorphine treatment and the proportion of illicit opioid-negative urine samples. Secondary measures include evaluating treatment effectiveness through the Treatment Effectiveness Assessment and monitoring sleep quality via the Pittsburgh Sleep Quality Index. The study is being conducted at multiple sites, including the University of Utah in Salt Lake City.
The study is sponsored by T. John Winhusen, PhD, of the University of Cincinnati. While the trial is recruiting participants, the National Institute on Drug Abuse (NIDA) notes that the U.S. government does not review or approve the safety and science of all studies listed on the ClinicalTrials.gov website.
