Semaglutide for Alcohol Use Disorder after bariatric (weight-loss) surgery
Semaglutide Treatment for Alcohol Use Disorder After Metabolic and Bariatric Surgery: A Pilot Randomized Controlled Trial
This trial will test whether semaglutide helps adults who had bariatric surgery and now have Alcohol Use Disorder and whether it also affects weight over a three-month treatment plus three-month follow-up.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT07223983 on ClinicalTrials.gov |
What this trial studies
This phase 1 interventional pilot will give semaglutide 1.0 mg to adults with prior laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy who meet DSM-5 criteria for Alcohol Use Disorder and have BMI within the eligible range. Participants will receive three months of semaglutide treatment with an additional three-month follow-up to measure feasibility and acceptability. The study will track changes in alcohol use, craving, and body weight as key outcomes. This single-site protocol at Yale School of Medicine is designed to inform whether a larger trial in this high-risk post-bariatric population is practical.
Who should consider this trial
Good fit: Adults 18 and older who had Roux-en-Y or sleeve gastrectomy within the past seven years, have BMI ≥30 (or ≥27 with a medical comorbidity) up to 50 kg/m2, meet DSM-5 criteria for Alcohol Use Disorder, are medically stable, and can read and write English may qualify.
Not a fit: Patients with recent major cardiac events, uncontrolled medical problems, BMI outside the eligible range, those who have not had bariatric surgery, or who cannot attend required visits are unlikely to benefit or be eligible for this trial.
Why it matters
Potential benefit: If successful, semaglutide could reduce drinking and help control weight in adults who develop Alcohol Use Disorder after bariatric surgery.
How similar studies have performed: A recent randomized controlled trial in other populations showed semaglutide reduced some alcohol craving and drinking outcomes, but this approach has not been tested in people after bariatric surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study (up to 6 months: 3-month treatment plus 3-month follow up) * Age 18 and older * Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and BMI ≤50 kg/m2 * Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy within the past seven years * Meet current DSM-5 criteria for Alcohol Use Disorder * Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators * Read, comprehend, and write English at a sufficient level to complete study-related materials * For females of reproductive potential: use of highly effective contraception and agreement to use such a method during study participation Exclusion Criteria: * Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior to screening * History or presence of chronic or recurrent pancreatitis * History of malignant neoplasms within the past 5 years prior to screening * Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 * Is currently using other medications for weight loss or other GLP-1 receptor agonists * Has a history of allergy or sensitivity to Semaglutide * Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression) * Has untreated hypertension with a seated systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg, or heart rate \> 100 beats/minute * Has current uncontrolled hypertension * Has current uncontrolled Type I or Type II diabetes mellitus * Has untreated hypothyroidism with a TSH \> 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit * Has active gallbladder disease * Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder * Has a recent history of substance use disorder (with the exception of cannabis or tobacco use disorder) within the past 12 months * Is currently engaging in other treatment for Alcohol Use Disorder or making intentional efforts to quit alcohol use * Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device * Is breast-feeding, pregnant, or not using a reliable form of birth control * Reports active suicidal or homicidal ideation * Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria which, in the investigator's opinion, might have jeopardized the participant's safety or compliance with the protocol
Where this trial is running
New Haven, Connecticut
- Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Valentina Ivezaj, PhD — Yale University
- Study coordinator: Valentina Ivezaj, PhD
- Email: valentina.ivezaj@yale.edu
- Phone: 203-785-7807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.