NCT05096117

Human Laboratory Study of ASP8062 for Alcohol Use Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Use Disorder
• Alcohol Drinking
• Alcohol Use Disorder (AUD)

Interventions

Type	Name	Description
DRUG	ASP8062	ASP8062 is a novel compound with positive allosteric modulator (PAM) activity on the γ-aminobutyric acid type B (GABAB) receptor, 25 mg, 1 x per day for 6 weeks
DRUG	Placebo	1 x per day for 6 weeks

Timeline

• Start date: 2021-12-13
• Primary completion: 2023-03-22
• Completion: 2023-03-22
• First posted: 2021-10-27
• Last updated: 2024-12-03
• Results posted: 2024-12-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study