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Study of Tirzepatide for Recovery and Alcohol Use Management

RecruitingPhase 2

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

Sponsor: Brigham and Women's Hospital · Participants: 20 · Started: Sep 15, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06727331

Locations in the U.S.

MassachusettsBrigham 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.