Semaglutide Weekly Injection to Reduce Illicit Opioid Use in Adults with Opioid Use Disorder Receiving Buprenorphine or Methadone Treatment

What this Trial Is About

This clinical trial studies adults with opioid use disorder who are in outpatient treatment and receiving buprenorphine or methadone maintenance therapy. The research aims to find out if semaglutide, a glucagon-like peptide-1 receptor GLP-1R agonist, can reduce the use of illicit and nonprescribed opioids compared to a placebo. The study is a phase 2, randomized, and quadruple-blinded trial designed to evaluate treatment effects over several weeks. Participants will be randomly assigned to receive either semaglutide or a placebo via a weekly subcutaneous injection for 12 weeks. The semaglutide dose starts low at 0.25 mg and is gradually increased up to 1.0 mg weekly based on tolerance. After the 12-week intervention, there is a 1-week washout period without treatment, followed by a final follow-up visit about 4 weeks later. The placebo group receives a dry needle stick weekly without any drug. Throughout the study, participants visit the clinic weekly for urine drug screening, pregnancy tests, vital sign checks, and to complete mental health and drug use questionnaires. They also complete smartphone surveys during the study. Blood samples are collected twice, and a physical exam with medical history is done at baseline. Researchers measure abstinence from illicit opioids weekly during treatment and assess opioid cravings and stimulant use as secondary outcomes. Participation lasts about 19 weeks in total.

GLP-1R Agonist Treatment for Opioid Use Disorder