Human Laboratory Study of ASP8062 for Alcohol Use Disorder
Status:
Not yet recruiting
Trial end date:
2023-01-30
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the effects of ASP8062, 25 mg once a day
and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory
paradigm after 2 weeks of daily dosing among subjects with moderate to severe alcohol use
disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders -
Fifth Edition (DSM-5™). Secondary objectives include evaluation of ASP8062, 25 mg once a day,
and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking
(among smokers) and nicotine use (among nicotine users), mood, sleep, alcohol use negative
consequences, study retention, and safety and tolerability throughout the last 4 weeks of the
treatment phase of the study.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)