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

What Was Tested

The trial (phase 3) is built around Semaglutide.

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.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

Weekly subcutaneous injections of placebo mimicking treatment procedure.

The registry classes the interventions as drug.

More on the Plan

Background: AUD is one of the leading causes of disability worldwide.

Randomization will be stratified according to BMI (\<30 or ≥ 30) and participating site.

Veterans with DSM-5-diagnosed moderate to severe AUD who are seeking treatment will be invited to participate in this trial.

After eligibility screening, participants will be randomized to either the semaglutide group or the placebo group.

Who Took Part

Enrollment: 622 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: World Health Organization's (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 alcohol use disorder (AUD), i.e., meeting at least 4 of 11 DSM-5 AUD criteria, based on semi-structured diagnostic exam, the Mini-International Neuropsychiatric Interview (MINI). Able and willing to provide informed consent.

The full record lists 5 inclusion and 55 exclusion criteria; among the exclusions: medical history (medical history form); type 1 diabetes; history of acute or chronic pancreatitis.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-07-28 with completion listed for 2029-03-31.

It ran at 19 sites in United States (19).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Adverse events of special interest (assessment of safety and tolerability), No heavy drinking days over the last 28 days of intervention and Moderation effects of baseline characteristics.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 622 people.

With 622 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.