NCT07223983 · Yale University
Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS)
What this study is about
The purpose of this research study is to evaluate the feasibility of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight or obesity.
View original scientific description
The purpose of this research study is to evaluate the feasibility of treating Alcohol Use Disorder with Semaglutide after metabolic and bariatric surgery in adults with overweight or obesity.
Interventions
DRUG
Semaglutide 1.0 mg
Participants randomized to Semaglutide will be initiated on a 0.25 mg dose (injection) once weekly for 4 weeks (first month) with an escalation to 0.5 mg for the second month, and 1.0 mg in the final month (three months total).
Primary outcome measures
Percent weight change
Time frame: Baseline, Week 12, 6-month follow-up
Percent weight change will be calculated. Negative values are indicative of weight loss. Positive values are indicative of weight gain.
Mean drinks per calendar day to assess alcohol use
Time frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean drinks per calendar day will be assessed through timeline follow back interviews
Mean drinks per drinking day to assess Alcohol use
Time frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean drinks per drinking day will be assessed through timeline follow back interviews
Mean number of heavy drinking days to assess Alcohol use
Time frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of heavy drinking days will be assessed through timeline follow back interviews
Mean number of drinking vs abstinent days to assess Alcohol use
Time frame: Baseline, Week 4, Week 8, Week 12, 6-month follow-up
Mean number of drinking vs abstinent days will be assessed through timeline follow back interviews
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New Haven, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations