Study of Tirzepatide for Recovery and Alcohol Use Management
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Alcohol Use Disorder (AUD)
In brief
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.
Key facts
- Study ID
- NCT06727331
- Run by
- Brigham and Women's Hospital
- People needed
- 20
- Starts
- 2025-09-15
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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
Where it is running
- Brigham and Women's Faulkner Hospital — Jamaica Plain, Massachusetts, United States (enrolling)
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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