Actively Recruiting
Tirzepatide for Alcohol Use Disorder
Led by University of Southern California · Updated on 2025-10-14
42
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tirzepatide for Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meeting past-year DSM-5 criteria for alcohol use disorder with at least moderate severity (4 or more symptoms)
- Average daily alcohol consumption of 40g or more for women, or 60g or more for men, in the 28 days before the study
- Body mass index of 27 kg/m2 or higher
- Willingness to attend weekly medication visits and complete all study procedures
- Ability to read and communicate in English
- Age between 21 and 65 years old
- Currently seeking treatment to reduce or stop drinking
- Stable housing status
You will not qualify if you...
- Past-year diagnosis of another substance use disorder except tobacco or mild cannabis use disorder
- Recent use (past 30 days) of illicit drugs (excluding cannabis) or non-prescribed opioids, or positive drug screen (except if prescribed opioid replacement therapy with documentation)
- History of severe alcohol withdrawal symptoms such as seizures, delirium tremens, or hospitalization for withdrawal
- Recent (past 3 months) participation in alcohol treatment or mandated treatment
- History of chronic or acute pancreatitis
- History of diabetes or diabetes-related conditions, or HbA1C of 6.5% or higher
- History of suicide attempt or recent active suicidal thoughts
- Lifetime diagnosis of severe mental illness like psychosis or bipolar disorder
- Significant anxiety or depression currently interfering with daily life unless stable or treated
- Treatment for eating disorder in the past 12 months
- Significant medical, neurological, or psychiatric illness that would affect safe study participation
- History of liver disease or elevated liver-related lab tests
- History of cancer in the last 5 years except non-melanoma skin cancer
- Inability to attend weekly clinic visits
- Recent weight loss over 5% in the last 30 days
- Current participation in another clinical trial with investigational product
- Living with a current or former participant of this trial
- Living with someone taking GLP-1 receptor agonist therapy
- Planned surgery requiring anesthesia within 90 days after starting the study
- Previous treatment with tirzepatide or GLP-1 receptor agonists within 6 months
- Recent use of weight loss or alcohol reduction medications in past 3 months
- Personal or family history of certain thyroid cancers or endocrine conditions
- Impaired kidney function indicated by low eGFR
- Use of medications unsafe with tirzepatide per study doctor
- Known bone, muscle, or wasting conditions
- Significant or uncontrolled gastrointestinal conditions affecting treatment
- Pregnancy, nursing, or inability to use reliable birth control if female of childbearing age
- Uncontrolled high blood pressure at baseline
- Recent heart attack or stroke in last 6 months
- Reduction in alcohol consumption below specified thresholds before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Keck School of Medicine, University of Southern California
Los Angeles, California, United States, 90032
Actively Recruiting
Research Team
C
Christian Hendershot, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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