RecruitingPhase 3

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

United States622 participantsStarted 2026-07-28

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Veteran * WHO risk drinking level of Very High or High in the 28 days prior to screening (based on screening TLFB) * Current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria) based on semi-structured diagnostic exam (MINI) * Able and willing to provide informed consent * Has a desire to reduce their alcohol consumption Exclusion Criteria: * Medical History (medical history form) * Type 1 diabetes * History of acute or chronic pancreatitis * History of diabetic ketoacidosis * History of proliferative diabetic retinopathy * History of ascites, advanced liver fibrosis, compensated cirrhosis with portal hypertension, decompensated cirrhosis, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or hepatocellular carcinoma (HCC) * History of advanced fibrosis or cirrhosis, including (but not limited to) transient elastography (liver stiffness) of \>12 kPa, FIB-4 ≥2.67, ELF ≥9.8, MRE ≥3.63 kPa * History of stage 3 fibrosis or stage 4 cirrhosis from a liver biopsy * History of esophageal varices on endoscopy or imaging * History of nodular liver, cirrhosis, splenomegaly, varices or splenic venous shunting or collaterals on prior imaging * History or acute alcohol hepatitis (by liver biopsy or elevated bilirubin \> 1.5 times the upper limit of normal) * History of primary biliary cholangitis * History of primary sclerosing cholangitis * Current drug-induced liver disease …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Two-level reduction in the World Health Organization (WHO) risk drinking level assessed in the last 28 days of intervention

Timeframe: Change from baseline (after randomization) to change in the last 28 days of the intervention

Trial details

NCT IDNCT07218354

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2029-03-31

Contact for this trial

David W Oslin, MD

(215) 823-5894 Dave.Oslin@va.gov

View on ClinicalTrials.gov More Alcohol Use Disorder trials