Study of Tirzepatide for Recovery and Alcohol Use Management

NCT06727331 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2024P003497
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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)

Outcome Measures

Primary Outcomes (2)

• Cue-induced Cravings for Alcohol

  Cue-induced craving scores at follow-up compared to baseline using a standard cue-reactivity paradigm utilizing visual cues. Cravings will be measured on a scale from 0-10 with 10 meaning extreme cravings.

  Baseline visit and 5 weeks after baseline visit.

• Incidence and Severity of Adverse Events

  Study staff will be notified of any hospital admissions via Epic, and adverse events will be queried specifically using the Patient Rated Inventory of Side Effects (PRISE) at study weeks 2-5. The PRISE is a self-report tool to qualify side effects. For each domain, the patient indicates whether they have experienced certain symptoms and whether the symptoms are tolerable or distressing.

  Epic monitoring throughout the trial and PRISE administered at study weeks 2-5 (visits 3-6).

Secondary Outcomes (18)

• Penn Alcohol Craving Scale (PACS)

  At each study visit up to and including the final visit 5 weeks after baseline.

• Monetary Choice Questionnaire (MCQ)

  Baseline visit and 5 weeks after baseline visit.

• Visual Probe Task

  Baseline visit and 5 weeks after baseline visit.

• Percent days abstinent

  At each study visit up to and including the final visit 5 weeks after baseline.

• Percent heavy drinking days

  At each study visit up to and including the final visit 5 weeks after baseline.

Study Arms (2)

Tirzepatide

EXPERIMENTAL

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

Drug: Tirzepatide

Saline Placebo

PLACEBO COMPARATOR

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

Other: Saline Placebo

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.

Also known as: Mounjaro

Tirzepatide

Saline Placebo OTHER

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

Saline Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

ACTIVE NOT RECRUITING

Brigham and Women's Faulkner Hospital

Jamaica Plain, Massachusetts, 02130, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Joji Suzuki, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joji Suzuki, MD

CONTACT

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

Laura M Holsen, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The IDS will perform both the randomization and blinding and will be the only unblinded research staff. They will extract the tirzepatide and draw the dose into syringes, which will match visually with the placebo doses. All other research staff will remain blinded for the duration of the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Addiction Psychiatry

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: September 15, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (2)