Actively Recruiting
Study of Tirzepatide for Recovery and Alcohol Use Management
Led by Brigham and Women's Hospital · Updated on 2025-12-15
20
Participants Needed
2
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Tirzepatide for Recovery and Alcohol Use Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Active, Not Recruiting
2
Brigham and Women's Faulkner Hospital
Jamaica Plain, Massachusetts, United States, 02130
Actively Recruiting
Research Team
J
Joji Suzuki, MD
CONTACT
L
Laura M Holsen, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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