Study of Tirzepatide for Recovery and Alcohol Use Management

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06727331
Phase
PHASE2
Status
Recruiting
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Conditions

  • Alcohol Use Disorder (AUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — 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 — OTHER
    Placebo syringes of saline and matching volume will be produced by IDS.

Study Details

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 Dates

Start date
Sep 15, 2025
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Cue-induced Cravings for Alcohol [ Time Frame: Baseline visit and 5 weeks after baseline visit. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Brigham and Women's Faulkner HospitalJamaica PlainMassachusetts02130
Joji Suzuki, MD
[email protected]
617-732-5752
Jeong Hoo (Eric) Lee, MD
[email protected]
Joji Suzuki, MD (PRINCIPAL_INVESTIGATOR)
Jeong Hoo (Eric) Lee, MD (SUB_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MABrigham and Women's Faulkner Hospital· Jamaica Plain, MA

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