Semaglutide Therapy for Alcohol Reduction (STAR) trial investigates GLP-1 agonist's efficacy in adults with AUD

Alcohol Use Disorder (AUD) is a chronic, relapsing condition marked by compulsive drinking and loss of control, contributing to 5% of global annual deaths. Current pharmacotherapies for AUD are limited, highlighting an urgent need for novel interventions. Preclinical and initial human data suggest that the GLP-1R agonist semaglutide may modulate reward pathways and reduce alcohol intake, prompting this investigation into its efficacy for AUD.

This randomized, placebo-controlled clinical trial (STAR) is enrolling adults aged 18 or older with Alcohol Use Disorder (AUD). Participants will receive weekly subcutaneous injections of either semaglutide or placebo for 20 weeks. The study involves weekly visits to NIDA in Baltimore, lasting 2-6 hours, with a 7-week post-treatment follow-up. Assessments include blood, urine, and saliva sampling, self-paced behavioral therapy, questionnaires on mood, diet, and alcohol use, taste preference tests, and fMRI scans during exposure to alcohol cues.

This record describes a clinical trial protocol; therefore, no results or findings are available at this time. The study aims to evaluate the efficacy of semaglutide in reducing alcohol consumption and craving in individuals with Alcohol Use Disorder (AUD). Data collection is ongoing, and future publications will detail the primary and secondary outcomes, including changes in drinking patterns, neural responses to alcohol cues, and overall tolerability of the intervention.