Tirzepatide to reduce alcohol cravings in adults with alcohol use disorder
Tirzepatide for the Treatment of Alcohol Use Disorder: A Pilot Randomized Controlled Trial
This 4-week randomized, double-blind study tests whether weekly tirzepatide injections reduce cue-triggered cravings in adults with alcohol use disorder.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06727331 on ClinicalTrials.gov |
What this trial studies
This pilot phase 2, double-blind, placebo-controlled randomized trial will enroll 20 adults with DSM-5 alcohol use disorder to receive weekly tirzepatide or matching placebo for four weeks. The primary outcome is cue-reactivity measured with neurocognitive testing at baseline and end of treatment, and secondary outcomes include safety, preliminary efficacy on alcohol use, cravings, mood, and metabolic labs. Participants complete baseline, five weekly dosing visits, and a follow-up visit with vital signs, weight, urine toxicology, blood glucose, and questionnaires at each visit. Study medication is prepared by the investigational drug service and both participants and staff are blinded to assignment.
Who should consider this trial
Good fit: Adults (18+) who speak English, meet DSM-5 criteria for alcohol use disorder, have BMI ≥23, do not have diabetes or a lifetime eating disorder, are not taking GLP-1 or other glucose-lowering/anti-obesity medications, and can travel to the Brigham and Women's Hospital sites in Boston are the intended participants.
Not a fit: People with diabetes, a lifetime eating disorder, BMI under 23, recent or current use of GLP-1 or other glucose-lowering drugs, active psychosis or suicidality, or who cannot attend the Boston visits are unlikely to be eligible or to benefit from this pilot.
Why it matters
Potential benefit: If successful, tirzepatide could reduce cue-induced cravings and help people with AUD decrease drinking or maintain abstinence.
How similar studies have performed: Early preclinical and clinical studies of GLP-1 receptor agonists have suggested potential to reduce alcohol intake, but tirzepatide is a newer dual GIP/GLP-1 agent and remains novel for AUD with limited clinical data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Active_not_recruiting)
- Brigham and Women's Faulkner Hospital — Jamaica Plain, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Joji Suzuki, MD — Brigham and Women's Hospital
- Study coordinator: Joji Suzuki, MD
- Email: jsuzuki2@bwh.harvard.edu
- Phone: 617-732-5752
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.