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Tirzepatide for Alcohol Use Disorder

This study is testing tirzepatide, an FDA-approved medication, to see if it can help people with Alcohol Use Disorder (AUD). Researchers want to find out how tirzepatide affects alcohol cravings and if it's safe and effective for AUD. You might be able to join if you are an English-speaking adult, 18 or older, diagnosed with AUD, and can travel to the study clinic. The study will measure your alcohol cravings and check for any side effects. This is a small pilot study, with 20 participants, and the current recruitment status is unclear.

Study design
This is a small, 4-week, double-blind (meaning neither you nor the study staff will know if you're getting the active drug or placebo), placebo-controlled study with 20 participants.
What's involved
You will have six study visits over approximately five weeks. Visits 1 and 6 will be up to 3 hours, and visits 2-5 will be about 1 hour each. You will receive weekly injections of either tirzepatide or a placebo, and have vital signs, weight, urine tests, blood draws, and complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
You will have a final follow-up visit (Visit 6) at 5 weeks after your baseline visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06727331

Study of Tirzepatide for Recovery and Alcohol Use Management

Recruiting
PHASE2Ages 18+InterventionalTreatment
Brigham and Women's Hospital
~20 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:TirzepatideSaline Placebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cue-induced Cravings for Alcohol
Measured over Baseline visit and 5 weeks after baseline visit.
+1 more outcome measured

Conditions

Alcohol Use Disorder (AUD)

Explore related trials

Alcohol use disorder

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Joji Suzuki, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Joji Suzuki, MD
[email protected]
617-732-5752
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

English speaking adults aged 18 and above
Diagnosed with current DSM-5 alcohol use disorder
Willing and able to physically travel to BWH CCI outpatient facilities for study visits

Exclusion

CIWA score at screening ≥ 8.
Psychotic disorder, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent
Any lifetime diagnosis of eating disorders including anorexia, bulimia, binge eating, or avoidant/restrictive food intake disorder
BMI\<23 mg/kg2
Current or lifetime diagnosis of Type 1 or Type 2 diabetes
Current (or within 30 days of enrollment) use of any anti-obesity medications or medications with glucose lowering properties (including GLP-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-IV) inhibitors, or sodium-glucose cotransporter-2 (SGLT-2) inhibitors)
Use of any GLP-1 agonist medications in the prior 3 months
Anticipating receipt of any other GLP-1 agonist medications during the trial
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
Current hypoglycemia as indicated by a blood sugar level of ≤70 mg/dL measured at the baseline visit
Calcitonin ≥ 50 ng/L
Triglycerides ≥500 mg/dL
Untreated cholelithiasis or gallbladder disease
Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or congestive heart failure in the last 90 days
Uncontrolled hypertension at baseline, as indicated by an average blood pressure reading of \>180/110 after three successive readings
History of inflammatory bowel disease, bariatric surgery, pancreatitis, diabetic gastroparesis, or non-arteritic anterior ischemic optic neuropathy
Liver function test greater than 5 times upper normal limit
Renal impairment as indicated by eGFR of \<30
History of hypersensitivity or allergy to tirzepatide
Pregnant or breastfeeding
Anticipated to be enrolled in another clinical drug trial during participation in this trial
Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant

What this trial measures

  • Cue-induced Cravings for AlcoholBaseline visit and 5 weeks after baseline visit.

    Cue-induced craving scores at follow-up compared to baseline using a standard cue-reactivity paradigm utilizing visual cues. Cravings will be measured on a scale from 0-10 with 10 meaning extreme cravings.

  • Incidence and Severity of Adverse EventsEpic monitoring throughout the trial and PRISE administered at study weeks 2-5 (visits 3-6).

    Study staff will be notified of any hospital admissions via Epic, and adverse events will be queried specifically using the Patient Rated Inventory of Side Effects (PRISE) at study weeks 2-5. The PRISE is a self-report tool to qualify side effects. For each domain, the patient indicates whether they have experienced certain symptoms and whether the symptoms are tolerable or distressing.