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Human Laboratory Study of ASP8062 for Alcohol Use Disorder

Phase 2
Waitlist Available
Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4 & 6 of the treatment phase, averaged

Summary

This trial is testing a new drug called ASP8062 to see if it can reduce alcohol cravings in people with serious drinking problems. The goal is to find out if the drug helps reduce the urge to drink when exposed to alcohol-related cues.

Eligible Conditions
  • Alcoholism
  • Alcohol Consumption

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4 & 6 of the treatment phase, averaged
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4 & 6 of the treatment phase, averaged for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alcohol Craving
Secondary study objectives
Cigarettes Smoked Per Day (Among Smokers)
Drinks Per Drinking Day
Drinks Per Week
+10 more

Side effects data

From 2018 Phase 2 trial • 183 Patients • NCT03092726
29%
Dizziness
15%
Headache
6%
Nausea
3%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
ASP8062 30 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ASP8062 (25 mg once daily)Experimental Treatment1 Intervention
Group II: Matching PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASP8062
2021
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)Lead Sponsor
839 Previous Clinical Trials
1,083,711 Total Patients Enrolled
459 Trials studying Alcoholism
823,771 Patients Enrolled for Alcoholism
Astellas Pharma IncIndustry Sponsor
695 Previous Clinical Trials
234,417 Total Patients Enrolled
Raye Litten, Ph.D.Study DirectorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
~15 spots leftby Jan 2026
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