Study of Tirzepatide for Recovery and Alcohol Use Management
Tirzepatide for the Treatment of Alcohol Use Disorder: A Pilot Randomized Controlled Trial
Brigham and Women's Hospital
20 participants
Sep 15, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria22
- 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
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Interventions
This intervention will consist of the FDA-approved dosing schedule. Participants will receive 2.5mg weekly injections for 4 weeks. IDS will extract tirzepatide and draw the doses into syringes.
Placebo syringes of saline and matching volume will be produced by IDS.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06727331