Alcohol Use Disorder (AUD)Phase 2STREAMNCT06727331
Study of Tirzepatide for Recovery and Alcohol Use Management
A Phase 2 study testing Tirzepatide in people with Alcohol Use Disorder (AUD), run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2025to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Active, not recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
Brigham and Women's Faulkner Hospital
Jamaica Plain, Massachusetts, 02130
Joji Suzuki, MD, 617-732-5752, jsuzuki2@bwh.harvard.edu
Jeong Hoo (Eric) Lee, MD, jlee351@bwh.harvard.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Tirzepatide, Saline Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Mounjaro
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.
Saline PlaceboOther
Placebo syringes of saline and matching volume will be produced by IDS.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | This arm will receive tirzepatide (n=10) weekly 2.5mg injections for 4 weeks. Receives: Drug: Tirzepatide |
| Saline Placebo | Placebo comparator | This arm will receive saline placebo injections (n=10) weekly for 4 weeks. Receives: Other: Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cue-induced Cravings for Alcohol
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.
Measured: Baseline visit and 5 weeks after baseline visit.
Incidence and Severity of Adverse Events
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.
Measured: Epic monitoring throughout the trial and PRISE administered at study weeks 2-5 (visits 3-6).
Secondary outcomes (18)
Penn Alcohol Craving Scale (PACS)
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.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Monetary Choice Questionnaire (MCQ)
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.
Measured: Baseline visit and 5 weeks after baseline visit.
Visual Probe Task
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.
Measured: Baseline visit and 5 weeks after baseline visit.
Percent days abstinent
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.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Percent heavy drinking days
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.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Drinks per drinking day
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.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Clinical Institute Withdrawal Assessment (CIWA)
Tool for assessing alcohol withdrawal. Scale of 0-67, with a higher number meaning more severe withdrawal.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Blood Sugar
Blood glucose obtained via finger stick or blood already drawn for other tests.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Hemoglobin A1c
Hemoglobin A1c obtained via blood draw.
Measured: Baseline and 5 weeks after baseline visit.
Weight
Weight measured in kilograms.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Columbia Suicide Severity Rating Scale (C-SSRS)
A commonly used tool to assess suicidal ideation. The sum ranges from 2 to 25, with the higher number indicating more intense ideation.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Patient Health Questionnaire-8 (PHQ-8)
A tool to assess depression symptoms. Scale of 0-24, with a higher score meaning more depression symptoms.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Generalized Anxiety Disorder-7 (GAD-7)
A standard tool to assess anxiety symptoms. Scale of 0-21 with a higher number indicating more anxiety.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Heart rate
Heart rate measured in beats per minute.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Blood pressure
Blood pressure measured in systolic/diastolic (mmHg/mmHg). mmHg = millimeters of mercury.
Measured: At each study visit up to and including the final visit 5 weeks after baseline.
Assessment of Blind
Measure of participant perception of whether they received the active study drug.
Measured: 5 weeks after baseline visit.
Stanford Efficacy of Treatment Scale (SETS)
A tool for measuring patient outcome expectancy in clinical trials.
Measured: Baseline visit.
Fibrosis-4 (FIB-4)
A non-invasive measure of liver fibrosis. The higher the score, the more severe the fibrosis.
Measured: Baseline visit and 5 weeks after baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start15 Sep 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joji Suzuki, MD, Brigham and Women's Hospital
- Investigators
- Joji Suzuki, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727331
- Sponsor's protocol ID
- 2024P003497
- Acronym
- STREAM
- Status last verified
- Jul 2026
- First submitted
- 5 Dec 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tirzepatide for the Treatment of Alcohol Use Disorder: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06727331
- Acronym / sponsor ID
- STREAM / 2024P003497
- Conditions
- Alcohol Use Disorder (AUD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideThis arm will receive tirzepatide (n=10) weekly 2.5mg injections for 4 weeks. |
| Saline Placebo | Placebo comparator | Other: Saline PlaceboThis arm will receive saline placebo injections (n=10) weekly for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: MounjaroThis 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. | Drug | Tirzepatide |
| Saline PlaceboPlacebo syringes of saline and matching volume will be produced by IDS. | Other | Saline Placebo |
Primary outcome
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.
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.
18 secondary outcomes
Penn Alcohol Craving Scale (PACS)
Time frame: At each study visit up to and including the final visit 5 weeks after baseline.
Monetary Choice Questionnaire (MCQ)
Time frame: Baseline visit and 5 weeks after baseline visit.
Visual Probe Task
Time frame: Baseline visit and 5 weeks after baseline visit.
Percent days abstinent
Time frame: 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.
Drinks per drinking day
Time frame: At each study visit up to and including the final visit 5 weeks after baseline.
Clinical Institute Withdrawal Assessment (CIWA)
Time frame: 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.
Hemoglobin A1c
Time frame: 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.
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 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.
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 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.
Blood pressure
Time frame: 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.
Stanford Efficacy of Treatment Scale (SETS)
Time frame: Baseline visit.
Fibrosis-4 (FIB-4)
Time frame: Baseline visit and 5 weeks after baseline visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joji Suzuki, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Alcohol Use Disorder (AUD), run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joji Suzuki, MD (617-732-5752, jsuzuki2@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cue-induced Cravings for Alcohol (time frame: Baseline visit and 5 weeks after baseline visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.