NCT06727331 Study of Tirzepatide for Recovery and Alcohol Use Management
| NCT ID | NCT06727331 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Alcohol Use Disorder (AUD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-09-15 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Joji Suzuki, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT06727331 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alcohol Use Disorder (AUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06727331 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06727331 currently recruiting?
Yes, NCT06727331 is actively recruiting participants. Contact the research team at jsuzuki2@bwh.harvard.edu for enrollment information.
Where is the NCT06727331 trial being conducted?
This trial is being conducted at Boston, United States, Jamaica Plain, United States.
Who is sponsoring the NCT06727331 clinical trial?
NCT06727331 is sponsored by Brigham and Women's Hospital. The principal investigator is Joji Suzuki, MD at Brigham and Women's Hospital. The trial plans to enroll 20 participants.