Tirzepatide for Alcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of Southern California
About 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.
Eligibility criteria
Qualifiers
Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)
Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline
Body mass index ≥ 27kg/m2
Willingness to attend weekly medication visits and complete all study procedures
Disqualifiers
Meeting past-year DSM-5 criteria for another substance use disorder (except tobacco use disorder or mild cannabis use disorder)
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.
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.
Recent (past 3 months) engagement in behavioral or pharmacological alcohol use treatment or currently mandated to receive treatment
Trial design
Treatments tested in this trial
- Tirzepatide
- Placebo injections
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Southern California
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov