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Semaglutide Treatment for Alcohol Use Disorder After Metabolic and Bariatric Surgery: A Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Yale School of Medicine
RECRUITING
New Haven
Contact Information
Primary
Valentina Ivezaj, PhD
valentina.ivezaj@yale.edu
203-785-7807
Backup
Caitlin Smith, PhD
caitlin.smith@yale.edu
203-785-7210
Time Frame
Start Date: 2026-03-06
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 10
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Yale University

This content was sourced from clinicaltrials.gov