A small clinical trial suggests that oral semaglutide may help some adults with alcohol use disorder reduce heavy drinking, adding to early evidence that GLP-1 medications could influence cravings and consumption beyond food.
The randomized, double-blind, placebo-controlled trial included 50 adults seeking treatment for moderate to severe alcohol use disorder. After eight weeks, participants assigned to oral semaglutide reported fewer heavy drinking days, fewer drinks when they did consume alcohol and lower day-to-day cravings than those given a placebo. However, the medication did not improve every outcome tested, including some measures collected in controlled laboratory settings.
The findings, published in The American Journal of Psychiatry, are preliminary. The study was too small and brief to establish whether semaglutide provides a safe and effective long-term treatment for alcohol use disorder. Semaglutide is not approved by the Food and Drug Administration for treating the condition.
“This study suggests oral semaglutide may help reduce heavy and harmful drinking, even in people who are not trying to quit alcohol entirely,” said Joseph Schacht, an associate professor of psychiatry at the University of Colorado Anschutz School of Medicine.
Semaglutide belongs to a class of medications called GLP-1 receptor agonists. These drugs are used to treat type 2 diabetes and obesity partly by influencing appetite, fullness and food intake. Researchers are now investigating whether their effects on reward and consumption-related behavior could extend to alcohol and other substances.
For the new trial, researchers randomly assigned participants to take oral semaglutide or a matching placebo once a day. The semaglutide dose increased from 3 milligrams during the first four weeks to 7 milligrams during the final four weeks. Participants in both groups also completed a computerized behavioral intervention during study visits.
Compared with the placebo group, people taking semaglutide reported reductions in heavy drinking days and the amount of alcohol consumed on drinking days. They also reported fewer alcohol-related problems and improvements in their overall drinking risk level. Cannabis use days declined as well, although that was not the study’s primary focus.
The results do not show that semaglutide eliminates alcohol cravings or reliably produces abstinence. Instead, they suggest it may help reduce some forms of harmful drinking, an approach sometimes known as harm reduction.
“It could represent a new treatment option for AUD, particularly for those who have not benefited from existing medications, and may reduce alcohol-related health and social harms,” Schacht said. “Importantly, even reducing heavy drinking can lead to meaningful improvements for patients and families.”
Alcohol use disorder is a medical condition marked by difficulty controlling alcohol use despite negative consequences. Although several medications are already available, they do not work for everyone, and no new medication has received FDA approval specifically for alcohol use disorder since 2006.
The oral form of semaglutide could potentially offer an alternative for people who are reluctant to use an injectable medication. Still, the trial did not compare oral and injectable semaglutide directly, so it cannot establish whether one form is more effective or acceptable than the other.
Side effects were generally mild, according to the researchers, and most participants adhered to the treatment and completed the trial. A study involving 50 people over eight weeks, however, cannot fully assess uncommon side effects, longer-term tolerability or what happens to drinking patterns after the medication is stopped.
Other unanswered questions include which patients might benefit most, what dose should be used and whether any reductions in drinking would continue with longer treatment. Larger trials are planned to investigate whether the early results hold up in broader groups of patients.
The study was supported by the National Institute on Alcohol Abuse and Alcoholism, the National Center for Advancing Translational Sciences through the Colorado Clinical and Translational Sciences Institute, the Hewit Family Foundation and an anonymous family donor. Schacht reported serving on a scientific advisory board for Apollo Therapeutics and consulting for SOURCE Bio. He also reported receiving funding as a site principal investigator for a study conducted by Altimmune, receiving study medication from Bausch Health and participating in the Alcohol Clinical Trials Initiative, which is currently supported by Eli Lilly and Imbrium Therapeutics.