GLP-1R Agonist Treatment for Opioid Use Disorder to Reduce Illicit Opioid Use in Adults Receiving Buprenorphine or Methadone

What this Trial Is About

Researchers are evaluating whether semaglutide, a glucagon-like peptide-1 receptor (GLP-1R) agonist, can reduce illicit opioid use in adults undergoing outpatient treatment for opioid use disorder. The study compares semaglutide with a placebo to see if it increases the chances that participants will avoid using illicit and nonprescribed opioids. This Phase 2 trial focuses on adults receiving maintenance treatment with either buprenorphine or methadone. Participants will be randomly assigned to receive either semaglutide or a placebo injection once a week for 12 weeks. The semaglutide dosage starts at 0.25 mg per week and is gradually increased to a maximum of 1.0 mg, depending on tolerance. After 12 weeks of treatment, there is a one-week washout period without medication, followed by a final follow-up visit about 4 weeks later. The placebo group receives a dry needle stick with no active drug. Throughout the study, participants visit the clinic weekly for urine drug tests, pregnancy tests, vital sign checks, and to complete mental health and drug use questionnaires. They also complete smartphone surveys at scheduled times. Blood samples are taken twice during the study, and a physical exam and medical history are recorded at baseline. The main outcome measured is the number of participants abstinent from illicit opioids each week during treatment and follow-up.

GLP-1R Agonist Treatment for Opioid Use Disorder