drugset / Trial / NCT05096117
Human Laboratory Study of ASP8062 for Alcohol Use Disorder
Phase 2
Completed
60 enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Astellas Pharma Inc · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ASP8062 | Unknown | 25 mg | — |