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Trial · Interventional

Active, not recruitingPhase 1Registry data

Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS)

Overview

Status
Active, not recruiting
Phase
Phase 1
Enrollment
4 participants (actual)
Sponsor
Yale University · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
26 Mar 2026
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
First posted
3 Nov 2025
Last update posted
10 Sept 2026
Conditions
Alcohol Use Disorder · Weight Loss · Bariatric Surgery Patients

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 1

    Semaglutide (SEMA) for Alcohol Use Disorder (AUD) After Metabolic and Bariatric Surgery (MBS)

    NCT07223983

    26 Mar 2026 to est. Feb 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • Semaglutide 1.0 mgDrug

Arms2

  • Experimental

    Semaglutide

    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. Participants will be on Semaglutide for three months total.

  • No intervention

    Wait-list control

    Participants randomized to wait-list control will be followed for three months but no treatment will be administered. At the conclusion of the study, participants in the wait list control group will be offered a three-month behavioral intervention to treat Alcohol Use Disorder, although this is not required.

Primary outcomes5

Outcomes the sponsor listed as primary.

  1. Percent weight change

    Time frame · Baseline, Week 12, 6-month follow-up

    Registry description

    Percent weight change will be calculated. Negative values are indicative of weight loss. Positive values are indicative of weight gain.

  2. Mean drinks per calendar day to assess alcohol use

    Time frame · Baseline, Week 4, Week 8, Week 12, 6-month follow-up

    Registry description

    Mean drinks per calendar day will be assessed through timeline follow back interviews

  3. Mean drinks per drinking day to assess Alcohol use

    Time frame · Baseline, Week 4, Week 8, Week 12, 6-month follow-up

    Registry description

    Mean drinks per drinking day will be assessed through timeline follow back interviews

  4. Mean number of heavy drinking days to assess Alcohol use

    Time frame · Baseline, Week 4, Week 8, Week 12, 6-month follow-up

    Registry description

    Mean number of heavy drinking days will be assessed through timeline follow back interviews

  5. Mean number of drinking vs abstinent days to assess Alcohol use

    Time frame · Baseline, Week 4, Week 8, Week 12, 6-month follow-up

    Registry description

    Mean number of drinking vs abstinent days will be assessed through timeline follow back interviews

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

8 results

Once-Weekly Semaglutide in Adults With Alcohol Use Disorder: A Randomized Clinical Trial.

Hendershot et al. 2025JAMA psychiatrycited by 213

PMID 39937469PMC11822619DOI 10.1001/jamapsychiatry.2024.4789PUB-39937469

CC BY8 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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