Study of Tirzepatide for Recovery and Alcohol Use Management (STREAM)

December 8, 2025 updated by: Joji Suzuki, MD, Brigham and Women's Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants include N=20 men and women with DSM5 diagnosis of AUD. Potential participants will be screened and enrolled only if they meet full inclusion criteria. After screening and baseline procedures (Visit 1) are complete, participants will be randomized to receive either tirzepatide or placebo. Following randomization, participants will be scheduled for five study visits (Visits 2-6). Each visit will last approximately 1 hour, except for study visits 1 and 6 which will take no more than 3 hours in order to conduct additional neurocognitive testing, including cue-induced cravings and decision-making tests. At all study visits, participants will complete vital signs, weight, urine toxicology testing, a blood draw for glucose, and questionnaires probing secondary outcomes (i.e. anxiety and depression, suicidality, substance use, opioid withdrawal symptoms, cravings, etc). At study visits 2-5, the weekly dose of tirzepatide or placebo will be administered, and assessment of adverse events will also be completed. Both participants and study staff (including raters) will be blinded to active drug vs. placebo. At visit 1, subjects' expectations about their potential treatment will be queried. The final visit, visit 6, also called the follow-up visit, will also assess subjects' guess as to which treatment they received. The medication will be purchased from the manufacturer and stored by IDS. The IDS will extract the tirzepatide and draw the dose into syringes, which will match visually with the placebo doses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Active, not recruiting
        • Brigham and Women's Hospital
      • Jamaica Plain, Massachusetts, United States, 02130
        • Recruiting
        • Brigham and Women's Faulkner Hospital
        • Contact:
        • Principal Investigator:
          • Joji Suzuki, MD
        • Contact:
        • Sub-Investigator:
          • Jeong Hoo (Eric) Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tirzepatide
This arm will receive tirzepatide (n=10) weekly 2.5mg injections for 4 weeks.
Drug: Tirzepatide
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.
Other Names:
  • Mounjaro
Placebo Comparator: Saline Placebo
This arm will receive saline placebo injections (n=10) weekly for 4 weeks.
Other: Saline Placebo
Placebo syringes of saline and matching volume will be produced by IDS.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cue-induced Cravings for Alcohol
Time Frame: Baseline visit and 5 weeks after baseline visit.
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
Time Frame: Epic monitoring throughout the trial and PRISE administered at study weeks 2-5 (visits 3-6).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Monetary Choice Questionnaire (MCQ)
Time Frame: Baseline visit and 5 weeks after baseline visit.
A self-report tool used to measure delayed discounting. Participants will be asked to pick one of the two choices given. Score calculated typically falls between 0.0 and 0.5, with smaller values indicating a lack of discounting and preference for delayed rewards and higher values indicating strong discounting and a preference for immediate rewards.
Baseline visit and 5 weeks after baseline visit.
Visual Probe Task
Time Frame: Baseline visit and 5 weeks after baseline visit.
A behavioral task to assess attentional bias. Alcohol-related and neutral images will be used, different from the ones used for the cue-reactivity paradigm to limit habituation. A pair of images will appear on the left and right of the screen for either a short (200ms) or long (500ms) stimulus duration to assess automatic orientating and controlled attention processing, respectively. Image pairs will be replaced by a probe in the location of either the opioid-related or neutral image. The probe will remain until the participant responds to identify the probe orientation by pressing the response keys as quickly as possible. This task will yield reaction times for analysis.
Baseline visit and 5 weeks after baseline visit.
Clinical Institute Withdrawal Assessment (CIWA)
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
Tool for assessing alcohol withdrawal. Scale of 0-67, with a higher number meaning more severe withdrawal.
At each study visit up to and including the final visit 5 weeks after baseline.
Blood Sugar
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
Blood glucose obtained via finger stick or blood already drawn for other tests.
At each study visit up to and including the final visit 5 weeks after baseline.
Hemoglobin A1c
Time Frame: Baseline and 5 weeks after baseline visit.
Hemoglobin A1c obtained via blood draw.
Baseline and 5 weeks after baseline visit.
Weight
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
Weight measured in kilograms.
At each study visit up to and including the final visit 5 weeks after baseline.
Heart rate
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
Heart rate measured in beats per minute.
At each study visit up to and including the final visit 5 weeks after baseline.
Blood pressure
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
Blood pressure measured in systolic/diastolic (mmHg/mmHg). mmHg = millimeters of mercury.
At each study visit up to and including the final visit 5 weeks after baseline.
Assessment of Blind
Time Frame: 5 weeks after baseline visit.
Measure of participant perception of whether they received the active study drug.
5 weeks after baseline visit.
Stanford Efficacy of Treatment Scale (SETS)
Time Frame: Baseline visit.
A tool for measuring patient outcome expectancy in clinical trials.
Baseline visit.
Penn Alcohol Craving Scale (PACS)
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
A self-report tool used to measure craving for alcohol during the past week. Participants respond to 5 questions on a scale of 0-6 for a total score of 0-30, with higher scores indicating stronger cravings.
At each study visit up to and including the final visit 5 weeks after baseline.
Percent days abstinent
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
The percentage of days abstinent from alcohol, defined as 0 drinks on a given day, out of all days queried. The study investigators will use the Time-Line Follow Back (TLFB), a gold-standard method of evaluating substance use, as well as weekly urine toxicology screens.
At each study visit up to and including the final visit 5 weeks after baseline.
Percent heavy drinking days
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
Percentage of heavy drinking days, defined as 5 or more drinks in one day for males and 4 or more drinks in one day for females, out of all days queried. The study investigators will use the Time-Line Follow Back (TLFB), a gold-standard method of evaluating substance use, as well as weekly urine toxicology screens.
At each study visit up to and including the final visit 5 weeks after baseline.
Drinks per drinking day
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
The average number of drinks per drinking day. A drinking day is a day in which one or more alcoholic beverages were consumed. The study investigators will use the Time-Line Follow Back (TLFB), a gold-standard method of evaluating substance use, as well as weekly urine toxicology screens.
At each study visit up to and including the final visit 5 weeks after baseline.
Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
A commonly used tool to assess suicidal ideation. The sum ranges from 2 to 25, with the higher number indicating more intense ideation.
At each study visit up to and including the final visit 5 weeks after baseline.
Patient Health Questionnaire-8 (PHQ-8)
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
A tool to assess depression symptoms. Scale of 0-24, with a higher score meaning more depression symptoms.
At each study visit up to and including the final visit 5 weeks after baseline.
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: At each study visit up to and including the final visit 5 weeks after baseline.
A standard tool to assess anxiety symptoms. Scale of 0-21 with a higher number indicating more anxiety.
At each study visit up to and including the final visit 5 weeks after baseline.
Fibrosis-4 (FIB-4)
Time Frame: Baseline visit and 5 weeks after baseline visit.
A non-invasive measure of liver fibrosis. The higher the score, the more severe the fibrosis.
Baseline visit and 5 weeks after baseline visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joji Suzuki, MD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024P003497

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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