Semaglutide pilot RCT to evaluate feasibility for Alcohol Use Disorder post-bariatric surgery

Individuals undergoing Metabolic and Bariatric Surgery (MBS) for obesity and related metabolic conditions face a heightened risk of developing or worsening Alcohol Use Disorder (AUD) post-operatively. This increased vulnerability is attributed to altered alcohol metabolism and changes in gut hormone signaling that impact brain reward pathways. Existing AUD treatments often have limited efficacy or significant side effects, underscoring a critical unmet need for novel, safer therapeutic options in this specific population. Glucagon-like peptide-1 (GLP-1) receptor agonists, such as Semaglutide, have demonstrated potential in modulating dopamine-related reward pathways, suggesting a promising new pharmacological approach to reduce addictive behaviors and cravings.

This Phase 1 pilot randomized controlled trial (NCT07223983) is designed to evaluate the feasibility and acceptability of Semaglutide for treating Alcohol Use Disorder (AUD) in adults with overweight or obesity following Metabolic and Bariatric Surgery (MBS). The study plans to enroll an estimated 10 participants, who will be randomized into either an experimental Semaglutide arm or a wait-list control group. Participants in the experimental arm will receive Semaglutide via subcutaneous injection once weekly for a total of three months. The dosing schedule involves an initiation at 0.25 mg for the first four weeks, escalating to 0.5 mg for the second month, and reaching 1.0 mg for the final month. The primary endpoints focus on assessing the feasibility and acceptability of this treatment protocol, alongside observing preliminary changes in alcohol use and body weight.

As this is a recruiting Phase 1 pilot randomized controlled trial (NCT07223983) with an estimated enrollment of 10 participants, no findings are available yet. The study is currently underway, with an estimated primary completion date of 2026-10-31. The primary objective is to evaluate the feasibility and acceptability of Semaglutide treatment for Alcohol Use Disorder after metabolic and bariatric surgery, and to observe preliminary changes in alcohol consumption and body weight. Future results will determine if Semaglutide can be a viable intervention in this patient group.