Tirzepatide to reduce alcohol cravings in adults with alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot phase 2, double-blind, placebo-controlled randomized trial will enroll 20 adults with DSM-5 alcohol use disorder to receive weekly tirzepatide or matching placebo for four weeks. The primary outcome is cue-reactivity measured with neurocognitive testing at baseline and end of treatment, and secondary outcomes include safety, preliminary efficacy on alcohol use, cravings, mood, and metabolic labs. Participants complete baseline, five weekly dosing visits, and a follow-up visit with vital signs, weight, urine toxicology, blood glucose, and questionnaires at each visit. Study medication is prepared by the investigational drug service and both participants and staff are blinded to assignment.

Why it matters

Who can join: the full rules

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

Where it's running

• Brigham and Women's Faulkner Hospital
  Jamaica Plain, Massachusetts, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Active not recruiting

Study contacts

• Principal investigator: Joji Suzuki, MD — Brigham and Women's Hospital
• Study coordinator: Joji Suzuki, MD
• Email: jsuzuki2@bwh.harvard.edu
• Phone: 617-732-5752

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.