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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugTirzepatide injections (2.5mg, 5.0mg)
Placebo injections
DrugPlacebo injections
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: TirzepatideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of heavy drinking days
Number of heavy drinking days (NHDD) during the last four weeks of treatment (treatment Weeks 5-8), as measured by the Timeline Followback interview. NHDD is defined as the total number of days on which participants consumed 5 or more drinks (for men) or 4 or more drinks (for women). The analysis of NHDD will control for baseline NHDD (defined as NHDD in the four weeks preceding treatment).
Time frame
Last 4 weeks of treatment (Weeks 5-8)Secondary outcomes
1
Drinks per drinking day
Drinks per drinking day (DDD) during the last four weeks of treatment (treatment Weeks 5-8) will be measured by the Timeline Followback interview. DDD is defined as average number of drinks consumed on drinking days. The analysis will control for baseline DDD (defined as DDD in the four weeks preceding treatment).
Time frame
Last 4 weeks of treatment (Weeks 5-8)2
WHO drinking risk level
WHO risk level is determined based on average grams of daily alcohol consumption, as measured by the Timeline Followback interview. WHO drinking risk level will be measured on a scale from 0-4 (corresponding to abstinence, low, moderate, high, or very high risk). The proportion of participants with a 1-level and 2-level reduction in WHO risk level between baseline (defined as the 28 days prior to the baseline visit) and the final month of treatment (Weeks 5-8) will be computed.
Time frame
Last 4 weeks of treatment (Weeks 5-8)3
Abstinent days
Abstinent days (proportion of days on which no alcohol consumption is reported) during the last four weeks of treatment (treatment Weeks 5-8) will be measured by the Timeline Followback interview. The analysis will control for baseline (defined as proportion of abstinent days in the four weeks preceding treatment).
Time frame
Last 4 weeks of treatment (Weeks 5-8)4
Absence of heavy drinking
Absence/remission of heavy drinking in the last month of treatment (treatment Weeks 5-8) will be measured by the Timeline Followback interview. Heavy drinking days are defined as consuming 5 or more drinks (for men) or 4 or more drinks (for women). The change in the proportion of participants with zero heavy drinking days from baseline (defined as the four weeks preceding treatment) to the Weeks 5-8 will be compared across treatment groups.
Time frame
Last 4 weeks of treatment (Weeks 5-8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern California
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov