Study of Tirzepatide for Recovery and Alcohol Use Management
NCT06727331 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-12-15
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)
Interventions
- 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.
- OTHER
-
Saline Placebo
Placebo syringes of saline and matching volume will be produced by IDS.
Sponsors & Collaborators
-
Brigham and Women's Hospital
lead OTHER
Principal Investigators
-
Joji Suzuki, MD · Brigham and Women's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-15
- Primary Completion
- 2026-05-31
- Completion
- 2026-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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