A Novel Human Lab Model for Screening AUD Medications
Status:
Recruiting
Trial end date:
2022-08-31
Target enrollment:
Participant gender:
Summary
This study design consists of a randomized, double-blind, placebo-controlled, 3-arm,
parallel-group study of naltrexone (50 mg QD) and varenicline (1 mg BID). A total of 108 men
and women with current AUD (moderate or severe) and reporting intrinsic motivation to change
their drinking, will be randomly assigned to receive naltrexone (50 mg QD), varenicline (1 mg
BID) or matched placebo. Post-randomization, all participants will complete an alcohol
cue-reactivity paradigm prior to the initial dose of study medication. After a week-long
medication titration period, participants will be asked to complete a 7-day practice quit
attempt, during which they will have daily virtual visits (phone and online) where they will
report on their alcohol use. Additionally, a second cue-reactivity paradigm will be conducted
90 minutes following study drug administration on final day of the practice quit attempt (Day
14).
Phase:
Phase 2
Details
Lead Sponsor:
University of California, Los Angeles
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)