NCT06727331: STREAM

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

Recruiting now Phase 2 Last updated 8 December 2025

What this trial tests

Phase 2 trial testing Tirzepatide in Alcohol Use Disorder (AUD) in 20 participants. Currently enrolling.

Timeline

15 September 2025

Primary endpoint
1 May 2026

1 July 2026

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	20
Start date	15 September 2025
Primary completion	1 May 2026
Estimated completion	1 July 2026
Sites	2 locations across United States

Drugs / interventions tested

• Tirzepatide (TIRZEPATIDE) — full drug profile →
• Saline Placebo

Conditions studied

• Alcohol Use Disorder (AUD) — all drugs for Alcohol Use Disorder (AUD) →

Sponsor

Brigham and Women's Hospital

Who can join

18 and older, any sex, with Alcohol Use Disorder (AUD). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tirzepatide reduces alcohol drinking and relapse-like behaviours in rodents.
   Edvardsson CE, Adermark L, Gottlieb S, Alfreji S, et al · · 2026 · cited 4× · PMID 41506148 · DOI 10.1016/j.ebiom.2025.106119
2. Searching for New Pharmacological Treatments of Alcohol Use Disorder (AUD): Focus on GLP-1 Receptor Agonists.
   Zawilska JB, Zwierzyńska E, Wojcieszak J. · · 2026 · PMID 42196481 · DOI 10.3390/ijms27104502
3. GLP-1 Receptor Agonists for Treating Alcohol Use Disorder: A Critical Review.
   Woo S, Zhu G, Castro C, Phuong A, et al · · 2026 · PMID 42144979 · DOI 10.1111/acer.70312
4. Incretin-Based Therapies: A Novel Pathway in Addiction Treatment
   Dawid R, Joanna M, Justyna M, Bogdańska A, et al · · 2026
5. Glucagon-like peptide 1 receptor agonists in substance use disorders: A systematic review of ClinicalTrials.Gov.
   Patil S, Jha N, Jha MK. · · 2026 · PMID 41696398 · DOI 10.1016/j.abrep.2026.100671
6. Pharmacological interventions for alcohol use disorder: novel insights from recent clinical trials.
   McManus KR, Ray LA. · · 2026 · PMID 41611606 · DOI 10.1080/17512433.2026.2625341