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STREAM

RecruitingPhase 2

Study of Tirzepatide for Recovery and Alcohol Use Management

Tirzepatide for the Treatment of Alcohol Use Disorder: A Pilot Randomized Controlled Trial

Lead sponsor

Brigham and Women's Hospital

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alcohol / substance use

Key I/E criterion

—

Primary endpoints

•Alcohol consumption, change•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06727331

Org study ID2024P003497

Timeline

Milestones

Study first posted2024-12-10actual

Study start2025-09-15actual

Last update posted2025-12-15actual

Primary completion2026-05estimated (month precision)

Study completion2026-07estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Patient-reported / QoL

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

MASH / liver

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Weight

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

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Blood Sugar

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

descriptive

Secondary/protocol endpoint

Hemoglobin A1c

Time frame:Baseline and 5 weeks after baseline visit.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

1 endpoint

Secondary/protocol endpoint

Fibrosis-4 (FIB-4)

Time frame:Baseline visit and 5 weeks after baseline visit.

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Heart rate

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

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Blood pressure

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

descriptive, improvement

Patient-reported / QoL

5 endpoints

Secondary/protocol endpoint

Penn Alcohol Craving Scale (PACS)

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

descriptive, improvement

Secondary/protocol endpoint/low confidence

Monetary Choice Questionnaire (MCQ)

Time frame:Baseline visit and 5 weeks after baseline visit.

descriptive

Secondary/protocol endpoint

Patient Health Questionnaire-8 (PHQ-8)

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

descriptive

Secondary/protocol endpoint

Generalized Anxiety Disorder-7 (GAD-7)

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

descriptive, improvement

Secondary/protocol endpoint

Stanford Efficacy of Treatment Scale (SETS)

Time frame:Baseline visit.

descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Incidence and Severity of Adverse Events

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

Treatment-emergent AEs (any)

descriptive

Secondary/protocol endpoint

Columbia Suicide Severity Rating Scale (C-SSRS)

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

descriptive

Other clinical outcomes

7 endpoints

Primary/protocol endpoint/low confidence

Cue-induced Cravings for Alcohol

Time frame:Baseline visit and 5 weeks after baseline visit.

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Visual Probe Task

Time frame:Baseline visit and 5 weeks after baseline visit.

descriptive

Secondary/protocol endpoint

Percent days abstinent

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

Alcohol consumption, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent heavy drinking days

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

Alcohol consumption, change

percent change from baseline, improvement

Secondary/protocol endpoint

Drinks per drinking day

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

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Clinical Institute Withdrawal Assessment (CIWA)

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

descriptive

Secondary/protocol endpoint

Assessment of Blind

Time frame:5 weeks after baseline visit.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.