Human Laboratory Study of ASP8062 for Alcohol Use Disorder

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), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.

Timeline

Start

2021-12-13

Primary completion

2023-03-22

Completion

2023-03-22

Outcome

Missed primary endpoint

registry analysis (superiority test); ASP8062 (25 mg Once Daily) vs Matching Placebo; p = 0.784; Least Square Mean Difference .178; ANCOVA NCT05096117 ↗

Drugs

Indications