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/39937469Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID07223983
Semaglutide Treatment for Alcohol Use Disorder After Metabolic and Bariatric Surgery: A Pilot Randomized Controlled Trial
Led by Yale University · Updated on 2026-05-12
10
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
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
Brief Title
Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration (up to 6 months)
- Age 18 years or older
- Body mass index (BMI) of 30 or higher, or BMI of 27 or higher with a medical condition, up to 50 kg/m2
- Had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy surgery within the past 7 years
- Meets current DSM-5 criteria for Alcohol Use Disorder
- Otherwise healthy without uncontrolled medical problems as determined by study physicians
- Able to read, understand, and write English sufficiently to complete study materials
- For females who can become pregnant: agree to use highly effective contraception during the study
You will not qualify if you...
- Heart attack, stroke, unstable angina, or transient ischemic attack within 60 days before screening
- History or presence of chronic or repeated pancreatitis
- Cancer diagnosis within the past 5 years
- Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia type 2
- Currently using other weight loss medications or GLP-1 receptor agonists
- Allergy or sensitivity to Semaglutide
- Psychiatric conditions requiring hospitalization or intensive treatment (e.g., bipolar disorder, psychosis, severe depression)
- Untreated or uncontrolled high blood pressure or heart rate above specified limits
- Uncontrolled Type I or II diabetes
- Untreated hypothyroidism above lab limits
- Active gallbladder disease
- Severe kidney, liver, neurological, lung disease, or other unstable medical disorders
- Recent substance use disorder except cannabis or tobacco within past 12 months
- Currently receiving treatment for Alcohol Use Disorder or actively trying to quit
- Participation in another clinical trial involving investigational drugs or devices
- Pregnant, breastfeeding, or not using reliable birth control
- Active suicidal or homicidal thoughts
- Any other condition that may affect safety or study compliance as judged by investigators
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
Trial Site Locations
Total: 1 location
1
Yale School of Medicine
New Haven, Connecticut, United States, 06520
Actively Recruiting
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Research Team
V
Valentina Ivezaj, PhD
C
Caitlin Smith, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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