Study of Tirzepatide for Recovery and Alcohol Use Management
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: addiction
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; no BMI minimum stated; conditions: Alcohol Use Disorder (AUD)
- Interventions
- Tirzepatide; Saline Placebo
- Conditions
- Alcohol Use Disorder (AUD)
- Phase and size
- Phase 2 · 20 participants
- Dates
- Start 2025-09-15
Primary completion 2027-03-01 - Sponsor
- Brigham and Women's Hospital (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Cue-induced Cravings for AlcoholBaseline visit and 5 weeks after baseline visit.
- Incidence and Severity of Adverse EventsEpic monitoring throughout the trial and PRISE administered at study weeks 2-5 (visits 3-6).
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.