drugset / Trial / NCT05096117

Human Laboratory Study of ASP8062 for Alcohol Use Disorder

NCT05096117

RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject ASP8062 Unknown 25 mg