Study of Tirzepatide for Recovery and Alcohol Use Management

What Was Tested

This registered phase 2 trial tested Tirzepatide.

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.

It had two arms (groups): Tirzepatide (experimental) and Saline Placebo (placebo comparator).

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

The registry classes the interventions as drug and other.

More on the Plan

Potential participants will be screened and enrolled only if they meet full inclusion criteria.

After screening and baseline procedures (Visit 1) are complete, participants will be randomized to receive either tirzepatide or placebo.

Following randomization, participants will be scheduled for five study visits (Visits 2-6).

Each visit will last approximately 1 hour, except for study visits 1 and 6 which will take no more than 3 hours in order to conduct additional neurocognitive testing, including cue-induced cravings and decision-making tests.

Who Took Part

Enrollment: 20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 22 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2025-09-15 with completion listed for 2027-03-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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)).

It also tracked 18 secondary outcomes, for example Penn Alcohol Craving Scale (PACS), Monetary Choice Questionnaire (MCQ), Visual Probe Task, Percent days abstinent, Percent heavy drinking days and Drinks per drinking day.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 20 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.