Tirzepatide for Alcoholism
CH
Overseen ByChristian Hendershot, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Southern California
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults who struggle with alcohol use disorder and are also overweight or obese. Participants should be seeking treatment for their alcohol consumption.Inclusion Criteria
Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)
Treatment-seeking (i.e., currently seeking assistance to reduce or stop drinking)
Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline
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Exclusion Criteria
Currently enrolled in another clinical trial involving an investigational product
Treatment for eating disorder in the past 12 months
Current contact or co-habitation with a current or former participant in the present trial
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Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive weekly tirzepatide or placebo to evaluate effects on alcohol consumption and cardiometabolic outcomes
8 weeks
Weekly visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Tirzepatide
Trial Overview The study tests the effects of tirzepatide, a weekly injection, against a placebo to see if it helps reduce alcohol intake and improve heart-related health measures in participants.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TirzepatideExperimental Treatment1 Intervention
2.5mg (Weeks 1-4), 5.0mg (Weeks 5-8)
Group II: PlaceboPlacebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
Trials
956
Recruited
1,609,000+
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Trials
865
Recruited
1,091,000+
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