Once-Weekly Semaglutide in Adults With Alcohol Use Disorder: A Randomized Clinical Trial.
Christian S Hendershot, Michael P Bremmer, Michael B Paladino...
https://pubmed.ncbi.nlm.nih.gov/39937469/Actively Recruiting
Led by Yale University · Updated on 2026-05-12
10
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the feasibility and acceptability of using Semaglutide to treat Alcohol Use Disorder in adults with overweight or obesity who have undergone metabolic and bariatric surgery. The study also aims to examine changes in alcohol use disorder symptoms and weight. Previous research suggests Semaglutide may reduce alcohol cravings and drinking, but this has not been studied in individuals with a history of bariatric surgery who are at higher risk of alcohol misuse. Participants in the study are randomly assigned to one of two groups. Those in the Semaglutide group receive weekly injections starting with a 0.25 mg dose for the first month, increasing to 0.5 mg in the second month, and 1.0 mg in the third month. The treatment lasts three months in total. The control group is placed on a wait-list and receives no treatment during the initial three months but may be offered a behavioral intervention afterward. During the study, participants undergo assessments to measure changes in weight and alcohol use at baseline, during treatment at weeks 4, 8, and 12, and at a 6-month follow-up. Researchers track drinking frequency, amount, and heavy drinking days. Participants are also monitored for safety and adherence throughout the study, which lasts up to six months including follow-up.
CONDITIONS
Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS)
V
Valentina Ivezaj, PhD
C
Caitlin Smith, PhD
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Yale University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Semaglutide Injection (investigational) | No Intervention (Wait‑list Control) |
|---|---|---|
| What it is | Once‑weekly semaglutide injections with dose escalated from 0.25 mg to 1.0 mg over three months | Wait‑list control arm with no active treatment during the three‑month treatment period |
| Role in trial | Investigational treatment evaluated for feasibility and effects on alcohol use and weight | Comparator arm receiving no intervention during the trial |
| Primary use | Treatment of alcohol use disorder and weight change after bariatric surgery | Observation without active treatment to compare against investigational effects |
| How it is given or performed | Escalating subcutaneous injection once weekly over three months | No active intervention administered |
| Evidence status | Early randomized evidence suggests semaglutide may reduce some alcohol consumption measures and weight in AUD | No efficacy as this arm received no intervention |
| Important risks | Potential gastrointestinal side effects and appetite changes as seen in trials | No intervention‑related risks |
| Important limitations | Small phase I–II study; findings preliminary and specific to post‑bariatric population | Wait‑list does not control for placebo effects or active clinical contact |
| Patient impact | May reduce heavy drinking days and craving, potentially supporting recovery efforts | No direct patient benefit expected beyond natural recovery trajectory |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants randomized to Semaglutide will receive weekly injections with dose escalation over three months. Participants in the wait-list control group will be followed for three months without treatment.
Weekly visits for up to 12 weeks
Duration - 3 months
Participants are monitored for outcomes including weight change and alcohol use for an additional three months after treatment ends.
1 visit at 6 months post-baseline
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Christian S Hendershot, Michael P Bremmer, Michael B Paladino...
https://pubmed.ncbi.nlm.nih.gov/39937469/Yale University
Lead Sponsor