Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of a GLP-1 Receptor Agonist Semaglutide in U.S. Veterans With Alcohol Use Disorder

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
VA Office of Research and Development
Study ID
NCT07218354
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide — DRUG
    Weekly subcutaneous injections of semaglutide up to 2.4 mg/week or maximum tolerated dose. Initial dosing starting at 0.25 for weeks 1-4. Further titration up to 2.4 mg weekly starting at week 5.
  • Placebo — DRUG
    Weekly subcutaneous injections of placebo.

Study Details

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 28-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 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 effectiveness of semaglutide for treating AUD, potentially offering a new and more appealing treatment option.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Apr 28, 2028
Completion
May 26, 2029

Study Design

Enrollment
622 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    Weekly subcutaneous injections of semaglutide up to 2.4 mg/week or maximum tolerated dose. Initial dosing starting at 0.25 for weeks 1-4. Further titration up to 2.4 mg weekly starting at week 5.
  • Placebo Comparator: Placebo
    Weekly subcutaneous injections of placebo.

Primary Outcome Measure

Two-level reduction in the World Health Organization (WHO) risk drinking level [ Time Frame: Change from Baseline to Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PAPhiladelphiaPennsylvania19104-4551
David W Oslin, MD
[email protected]
215-823-5870
David W. Oslin, MD (STUDY_CHAIR)

Find similar trials in Philadelphia, PA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA· Philadelphia, PA

Related Studies