Clinical Trial

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

Study acronym: CRAVE
Recruiting Phase 3
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Summary
This clinical trial aims to test the effectiveness and safety of semaglutide, a GLP-1 receptor agonist, in treating moderate to severe alcohol use disorder (AUD) in Veterans. Participants who qualify will be randomly assigned to receive either semaglutide injections or placebo injections over a 24-week period, followed by a 4-week post-treatment safety assessment period. Participants receiving semaglutide will start with a low dose, gradually increasing to a maximum of 2.4 milligrams (mg) per week, depending on their tolerance. The primary measure of success will be a reduction in risky drinking, assessed through a reliable calendar-based interview method called the Timeline Follow-Back (TLFB), a well-validated calendar-based interview technique for recording daily alcohol consumption. The purpose of this research is to gather information on the safety and effectiveness of semaglutide for treating AUD, potentially offering a new and more appealing treatment option.
Protocol Amendment History 6 changes
critical Recruitment opened 2026-08-05
notable Primary completion pushed: 2028-04-28 -> 2029-03-31 2026-08-05
minor Completion pushed: 2029-05-26 -> 2030-03-30 2026-08-05
critical Primary endpoint(s) modified 2026-07-24
notable Trial sites expanded: 1 -> 19 locations 2026-07-24
notable Enrollment increased: 438 -> 622 participants 2026-04-16
Trial Details
NCT Number NCT07218354
Lead Sponsor VA Office of Research and Development
Conditions Alcohol Use Disorder
Enrollment 622 participants
Start Date 2026-07-28
Primary Completion 2029-03-31 (estimated)
Study Completion 2030-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-12