VA begins enrolling 622 veterans in trial of semaglutide for alcohol use disorder

The Department of Veterans Affairs has started recruiting for a 622-veteran trial testing whether semaglutide reduces drinking in people with alcohol use disorder, a condition the drug is not approved to treat ^[1]. Recruitment opened the week of Aug. 19 and is expected to take about two years ^[1].

The trial, led by psychiatrist David Oslin, chief of behavioral health at the Philadelphia VA, is running at 18 VA sites nationwide ^[1]. Half of participants will receive semaglutide for six months and half will receive a placebo, and participants will not know which group they are in ^[1]. To join, veterans must receive their health care through the VA, be 18 to 80 years old, and be drinking enough to meet criteria for moderate or severe alcohol use disorder ^[1]. People taking insulin or another diabetes medication cannot take part ^[1].

Oslin said the trial was designed around FDA requirements for an alcohol use disorder indication, including a treatment period of at least six months and a sample size large enough to test both efficacy and safety ^[1]. Semaglutide is already FDA-approved for other uses, so the goal would be to change its label to add alcohol use disorder, he said ^[1].

Oslin said the push came from patients rather than laboratory work. "The driving force has been really the groundswell of anecdotal and observational data from folks" who reported drinking less while taking GLP-1 drugs for diabetes or weight loss ^[1]. Three small U.S. trials have since been published, he said. One enrolled 40 people and was too small to change medical practice, and none were designed to meet the FDA's standard for proving efficacy ^[1].

The theory behind the study involves GLP-1 receptors in the brain that respond to reward and signal fullness. "These medicines will have the effect of reducing your desire to want to drink more," Oslin said ^[1]. Early trials suggested the effect on drinking was larger than that of current treatments, he said, but that finding needs to be confirmed in a larger study ^[1].

A Houston VA post also said that site is enrolling veterans in a clinical trial to evaluate efficacy ^[2].

Why it matters for patients

Alcohol use disorder affects roughly 28 million people in the United States, and fewer than 10 percent of them receive any treatment in a given year ^[1]. Oslin said part of the potential value is access: primary care doctors already prescribe GLP-1 drugs for diabetes and weight loss and may be more comfortable prescribing them than the medications currently used for alcohol use disorder, which they rarely prescribe ^[1]. "The impact is potentially very big," he said ^[1].

Nothing changes for patients right now. Semaglutide is not approved for alcohol use disorder, and the trial has not produced results ^[1]. Oslin also warned against obtaining these drugs outside legitimate channels. "I would discourage people from doing that when we don't know that they're safe and efficacious," he said ^[1].

The study is limited to veterans, and whether its results would apply to other patients has not been reported. How semaglutide would compare with existing alcohol use disorder treatments has also not been established ^[1].

Veterans who need support can reach the Veterans Crisis Line by dialing 988 and pressing 1, at VeteransCrisisLine.net/Chat, or by texting 838255 ^[1].

What happens next

Enrollment is expected to take about two years, and Oslin said he anticipates publishing results in about three years ^[1]. If the trial shows the drug is safe and effective, the FDA would still have to approve adding alcohol use disorder to the semaglutide label before it could be prescribed for that purpose ^[1]. Veterans interested in the Philadelphia site can call 215-823-5800, extension 203404 ^[1].