Semaglutide for Alcohol Use Disorder and Obesity: Testing 1.0 mg and 2.0 mg vs Placebo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 study lasting 20 weeks, enrolling adults with AUD and obesity (BMI 30–49.9) to compare semaglutide at 1.0 mg and 2.0 mg against placebo. The study uses a validated lab model to measure craving and stress, and tracks real-world alcohol intake and related outcomes during treatment and an 8-week follow-up. Participants will be 18–60 years old, with regular weekly alcohol use and DSM-V-confirmed AUD, and must be in good health to participate. The aim is to understand how semaglutide may influence cravings, stress responses, and drinking behavior.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and females ages 18-60 and BMI in 30-49.9 kg/m2;
* regular weekly alcohol use (at least 3X/week) prior to admission;
* must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V;
* Good health as verified by screening and physical examination;
* Able to read English and complete study evaluation;
* Able to provide informed written and verbal consent.

Exclusion Criteria:

* Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine;
* Current use of opiates;
* Current use of psychiatric medications, including benzodiazepine-based sedatives/anxiolytics and anticonvulsants, non SSRI antidepressants, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), acamprosate, naltrexone, antabuse, baclofen, varenicline;
* Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
* Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c \>6.5% and on current medications for T2D treatment;
* Significant underlying medical conditions, including history of pancreatitis, acute kidney injury, medullary thyroid cancer, or MEN syndrome, as well as other cerebral, renal, thyroid or cardiac pathology that would preclude study participation;
* Current use of any anti-obesity medications;
* Prior history of bariatric surgery or current intragastric balloon;
* Current participation in structured meal replacement or weight loss program;
* Weight loss of \>=10% over the preceding 6 months;
* Women who are pregnant, nursing or refuse use of reliable form of birth control.

Where it's running

• Yale Stress Center
  New Haven, Connecticut, United States Recruiting
• Yale Stress Center
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Rajita Sinha — Yale University
• Study coordinator: Rajita Sinha, Phd
• Email: rajita.sinha@yale.edu
• Phone: 2037375805

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Egg intake and gut health, HDL, and immune markers in adults

  This study tests whether daily egg whites or whole eggs affect gut microbiome, HDL function, metabolism, and immune profiles in adults with a range of BMIs.

  Recruiting University of Connecticut · Storrs, Connecticut · NCT07844616

• Imaging Mitochondrial Complex-I and Brain Metabolism in Alcohol Use Disorder

  This study tests whether PET imaging with [18F]BCPP-EF and [18F]FDG can reveal differences in brain energy use between adults with alcohol use disorder and healthy controls, and whether these measures relate to relapse risk.

  Recruiting Early Phase 1 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07825818

• Endurance exercise to see if it lowers alcohol use in adults with AUD and ALD

  A 12-week home-based cycling program added to standard care is tested to see if it reduces alcohol use and cravings in adults with alcohol use disorder and alcohol-related liver disease.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07824089

• Do beverage cues drive craving in adults with AUD

  In adults with alcohol use disorder, this study tests whether different non-alcoholic beverage cues can trigger cravings differently when people see and smell them without drinking.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT07788716

• TRIS: a mobile app with breathalyzer to support sobriety in alcohol use disorder

  A smartphone app with a connected breathalyzer tests for abstinence and uses small financial incentives to encourage sobriety for adults with AUD in Brazil.

  Recruiting University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07735585

• Body-focused mindfulness added to inpatient alcohol use disorder treatment

  This trial tests whether a body-focused mindfulness program can help people with alcohol use disorder feel more connected to their bodies and reduce cravings while in inpatient care.

  Recruiting Medical University of Warsaw · Warsaw, Mazovian · NCT07706660

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.