HLAB-002 of ANS-6637 for Alcohol Use Disorder

Summary

Primary: The primary objective of this study was to evaluate the effects of 2 different doses of ANS-6637, 200 mg (given as 2 x 100 mg tablets) and 600 mg (given as 2 x 300 mg tablets) once a day, and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 1 week 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: Secondary objectives included evaluation of ANS-6637 200 mg, ANS-6637 600 mg, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), 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

2019-10-08

Primary completion

2020-05-22

Completion

2020-05-22

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated early following enrollment of n=43 due to clinically significant increases in liver enzymes in 3 women following at least 3 weeks of dosing with both doses of ANS-6637.”

Drugs

Indications