RecruitingAlcohol Use DisorderObesity and OverweightAlcohol
Tirzepatide for Alcohol Use Disorder
Eligible age
21–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and cardiometabolic outcomes in adults with alcohol use disorder and overweight or obesity.
Sponsor: University of Southern California
You may qualify if…
- ✓ 1. Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)
- ✓ 2. Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline
- ✓ 3. Body mass index ≥ 27kg/m2
- ✓ 4. Willingness to attend weekly medication visits and complete all study procedures
- ✓ 5. Ability to read and communicate in English
- ✓ 6. Age 21-65
- ✓ 7. Treatment-seeking (i.e., currently seeking assistance to reduce or stop drinking)
- ✓ 8. Stable housing status
You may not qualify if…
- ✕ 1. Meeting past-year DSM-5 criteria for another substance use disorder (except tobacco use disorder or mild cannabis use disorder)
- ✕ 2. Recent (past 30 day) self-report of illicit drug use (excluding cannabis) or non-prescribed opioids; or positive urine screen for illicit drugs. A positive screen for opioids will be allowed if the participant is prescribed an opioid replacement therapy medication and can provide documentation.
- ✕ 3. History of significant alcohol withdrawal, as indicated by history of seizure, delirium tremens; history of hospitalization for withdrawal-related symptoms; a CIWA score \>9 at assessment; or a baseline score 4+ on the Prediction of Alcohol Withdrawal Severity (PAWS) scale.
- ✕ 4. Recent (past 3 months) engagement in behavioral or pharmacological alcohol use treatment or currently mandated to receive treatment
- ✕ 5. History of chronic or acute pancreatitis
- ✕ 6. History of Type 1 or Type 2 diabetes, or diabetes-related conditions (e.g., diabetic retinopathy), or baseline HbA1C ≥ 6.5%
- ✕ 7. History of suicide attempt or report of current (past 2 weeks) active suicidal ideation
- ✕ 8. Lifetime diagnosis of severe mental illness (e.g., psychosis or bipolar disorder)
Where it's recruiting
California
Los Angeles
Source: ClinicalTrials.gov · NCT06994338 · last updated 2025-10-14