Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07223983

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

Led by Yale University · Updated on 2026-05-12

10

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form
  • Willingness to comply with all study procedures and availability for up to 6 months (3-month treatment plus 3-month follow-up)
  • Age 18 years or older
  • Body Mass Index (BMI) of 30 or higher, or BMI of 27 or higher with a medical comorbidity, and BMI no greater than 50 kg/m2
  • Had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy within the past seven years
  • Meet 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 of reproductive potential: use of highly effective contraception and agreement to use it during the study
Not Eligible

You will not qualify if you...

  • Myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within 60 days before screening
  • History or presence of chronic or recurrent pancreatitis
  • History of malignant tumors within 5 years before screening
  • Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2
  • Currently using weight loss medications or other GLP-1 receptor agonists
  • Allergy or sensitivity to Semaglutide
  • Psychiatric conditions requiring hospitalization or intensive treatment (e.g., bipolar disorder, psychosis, severe depression)
  • Untreated hypertension with high blood pressure or heart rate above specified limits
  • Current uncontrolled hypertension
  • Current uncontrolled Type I or II diabetes
  • Untreated hypothyroidism with abnormal TSH levels
  • Active gallbladder disease
  • History of severe kidney, liver, neurological, chronic lung disease, or other unstable medical disorders
  • Substance use disorder (except cannabis or tobacco) within past 12 months
  • Currently receiving treatment for Alcohol Use Disorder or actively trying to quit alcohol
  • Participating in another clinical study with investigational or non-investigational drugs or devices
  • Pregnant, breast-feeding, or not using reliable birth control
  • Active suicidal or homicidal thoughts
  • Any other condition that may jeopardize safety or study compliance as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

C

Caitlin Smith, PhD

CONTACT

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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