NCT06994338 Tirzepatide for Alcohol Use Disorder
| NCT ID | NCT06994338 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Southern California |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2025-10-06 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 9. Evidence of a significant anxiety or depressive disorder that is currently interfering with daily functioning, based on GAD-7 and PHQ-9 scores and physician judgement. (Anxiety or depression are not exclusionary if symptoms are stable/non-interfering with daily activities, or if the participant is receiving treatment, i.e., psychiatric medications have not changed for at least 3 months prior to baseline) 10. Treatment for eating disorder in the past 12 months 11. Report of significant medical, neurological, or psychiatric illness that would preclude safe or full study participation based on the judgement of the study physicians 12. History of known liver disease 13. Elevated serum lipase, amylase, bilirubin, or ALP, ALT, or AST (\>3x upper limit of normal range) 14. History of malignant neoplasms in the last 5 years, except for non-melanoma skin cancer 15. Inability to attend weekly clinic visits as scheduled (i.e., based on travel or work schedule) 16. Weight loss \> 5% in the 30 days prior to screening 17. Currently enrolled in another clinical trial involving an investigational product 18. Current contact or co-habitation with a current or former participant in the present trial 19. Current co-habitation with a person taking GLP-1RA therapy 20. Planned surgical procedures requiring anesthesia within 90 days post-entry into the study 21. History of treatment with tirzepatide or a GLP-1RA within 6 months of screening 22. Treatment with any weight loss medications (e.g., orlistat, bupropion-naltrexone) or medications known to reduce alcohol consumption (e.g., naltrexone, topiramate, acamprosate, varenicline) in the past 3 months 23. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type I or type II 24. Estimated glomerular filtration rate (eGFR) \<60 (indicated impaired kidney function) 25. Use of prescribed or non-prescribed medications that would preclude safe use of tirzepatide in the judgement of the study physicians 26. Known bone, muscle, or wasting conditions (e.g., osteoporosis, sarcopenia) aa. Presence of significant or uncontrolled GI conditions (e.g., GERD) that would interfere with treatment in the judgement of study physicians bb. Any other significant disease, disorder, or finding that in the opinion of the investigator(s) may increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data. cc. Currently pregnant or nursing, or inability to adhere to a reliable method of birth control (applies to female participants of childbearing age) dd. Uncontrolled hypertension at baseline, as indicated by an average blood pressure reading of \>180/110 after three successive readings ee. History of heart attack or stroke in the 6 months prior to screening ff. A pre-treatment reduction in alcohol consumption to \< 40g/day (males) or \<20g/day (females) in the interval between baseline screening and randomization
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06994338 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06994338 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06994338 currently recruiting?
Yes, NCT06994338 is actively recruiting participants. Contact the research team at christian.hendershot@usc.edu for enrollment information.
Where is the NCT06994338 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06994338 clinical trial?
NCT06994338 is sponsored by University of Southern California. The trial plans to enroll 42 participants.