Testing Weekly Semaglutide Injections to Reduce Alcohol Use in Veterans With Moderate to Severe Alcohol Use Disorder

What this Trial Is About

Researchers are evaluating the effects of semaglutide, a GLP-1 receptor agonist, on moderate to severe alcohol use disorder AUD in U.S. Veterans. This randomized, double-blind, placebo-controlled phase 3 trial compares semaglutide to placebo to determine its safety and effectiveness in reducing risky drinking. The study addresses a critical need for new AUD treatments, given the limitations of current medications and the large number of Veterans affected by AUD yet not receiving pharmacotherapy. Participants will receive weekly subcutaneous injections of either semaglutide or placebo for 24 weeks. Semaglutide dosing starts at 0.25 mg per week for the first 4 weeks, then gradually increases up to a maximum of 2.4 mg weekly, depending on tolerance. The placebo group receives injections that mimic the treatment procedure. After the treatment phase, a 4-week safety assessment period will follow. During the study, participants will be monitored for alcohol consumption using the Timeline Follow-Back interview and other assessments of drinking risk and symptoms. Researchers will also evaluate safety, tolerability, psychiatric symptoms, quality of life, and healthcare utilization. The primary outcome is a two-level reduction in World Health Organization risk drinking level during the last 28 days of treatment. The total study duration includes recruitment, treatment, follow-up, data cleaning, and analysis phases spanning several years.

Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized Controlled Trial for Alcohol Use Disorder (CRAVE)