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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
Condition: Alcohol Use Disorder · Sponsor: VA Office of Research and Development
About this study
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.
This description comes directly from the study's public registry record.
Talk to the study team
David W Oslin, MD · (215) 823-5870 · Dave.Oslin@va.gov
Neil C Johnson, MA BA · (702) 202-8387 · neil.johnson@va.gov
Always discuss trial participation with your own doctor first.
Locations (19)
| VA Long Beach Healthcare System, Long Beach, CA | Long Beach, California, United States | — |
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto, California, United States | — |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles, California, United States | — |
| Orlando VA Healthcare System, Orlando, FL | Orlando, Florida, United States | — |
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur, Georgia, United States | — |
| Edward Hines Jr. VA Hospital, Hines, IL | Hines, Illinois, United States | — |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor, Michigan, United States | — |
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis, Minnesota, United States | — |
| Asheville VA Medical Center, Asheville, NC | Asheville, North Carolina, United States | — |
| Durham VA Medical Center, Durham, NC | Durham, North Carolina, United States | — |
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland, Ohio, United States | — |
| VA Portland Health Care System, Portland, OR | Portland, Oregon, United States | — |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07218354