Recruiting
Phase 2

Tirzepatide

Sponsor:

Brigham and Women's Hospital

Code:

NCT06727331

Conditions

Alcohol Use Disorder (AUD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Saline Placebo

Study Details

Brief 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.

Conditions

Alcohol Use Disorder (AUD)

Study ID

NCT06727331

Start date

Sep 15, 2025

Status verified date

Jul, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tirzepatide

This arm will receive tirzepatide (n=10) weekly 2.5mg injections for 4 weeks.

placebo comparator: Saline Placebo

This arm will receive saline placebo injections (n=10) weekly for 4 weeks.

Interventions

Tirzepatide

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

Placebo syringes of saline and matching volume will be produced by IDS.

Primary outcome measure

  • Cue-induced Cravings for Alcohol [ Time Frame: Baseline visit and 5 weeks after baseline visit. ]
  • Incidence and Severity of Adverse Events [ Time Frame: Epic monitoring throughout the trial and PRISE administered at study weeks 2-5 (visits 3-6). ]

Central Contacts and Locations

Central contacts

Joji Suzuki, MD

617-732-5752jsuzuki2@bwh.harvard.edu

Laura M Holsen, Ph.D.

617-525-8772lholsen@bwh.harvard.edu

Locations

Brigham and Women's Faulkner Hospital

Recruiting

Jamaica Plain, Massachusetts, United States, 02130

Contacts

Joji Suzuki, MD

617-732-5752jsuzuki2@bwh.harvard.edu

Jeong Hoo (Eric) Lee, MD

jlee351@bwh.harvard.edu

Principal Investigator:

Joji Suzuki, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-09.