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Study of Tirzepatide for Recovery and Alcohol Use Management
Tirzepatide for the Treatment of Alcohol Use Disorder: A Pilot Randomized Controlled Trial
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
This is a pilot, 4-week, double-blind, placebo-controlled, randomized trial of individuals with alcohol use disorder (AUD) to receive weekly injections of either tirzepatide (n=10) or matching placebo (n=10). The primary aim is to determine the effects of tirzepatide on cue-reactivity among individuals with AUD. The secondary aim is to assess the safety and preliminary efficacy of tirzepatide for AUD.
What is being tested
- Tirzepatide (drug)
- Saline Placebo (other)
Sponsor: Brigham and Women's Hospital · Participants: 20 · Started: Sep 15, 2025
Contact the study team
- Joji Suzuki, MD · Phone: 617-732-5752
- Laura M Holsen, Ph.D. · Phone: 617-525-8772
Official record on ClinicalTrials.gov — NCT06727331
Locations in the U.S.
| Massachusetts | Brigham and Women's Faulkner Hospital, Jamaica Plain |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.