What this study is
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's being tested
- Tirzepatide
Intervention · DRUG
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.
- Saline Placebo
Intervention · OTHER
Placebo syringes of saline and matching volume will be produced by IDS.
Study details
- Official title
- Tirzepatide for the Treatment of Alcohol Use Disorder: A Pilot Randomized Controlled Trial
- Sponsor
- Brigham and Women's Hospital
- Conditions
- Alcohol Use Disorder (AUD)
- Enrolling
- 20 people
- Starts
- 2025-09-15
- Est. completion
- 2027-07-01
- Design
- Triple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
1 openBrigham and Women's Faulkner Hospital
Jamaica Plain, Massachusetts, United States
- Joji Suzuki, MD · Contact617-732-5752jsuzuki2@bwh.harvard.edu
- Jeong Hoo (Eric) Lee, MD · Contactjlee351@bwh.harvard.edu
- Joji Suzuki, MD · Principal investigator
- Jeong Hoo (Eric) Lee, MD · Sub-investigator
RecruitingBrigham and Women's Hospital
Boston, Massachusetts, United States
Active, not recruiting
Study team
Sponsor
Brigham and Women's Hospital
Study ID 2024P003497
Principal investigator
Joji Suzuki, MD
Brigham and Women's Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.