Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms

Summary

Randomized, multi-center, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized to receive either 0.33 mg AD04 or placebo orally twice-daily for 24 weeks in conjunction with brief psychological counseling. Randomization will be stratified by: 1. Level of alcohol consumption prior to enrollment in the study (heavy drinkers averaging \<10 drinks per day of drinking or very heavy drinkers averaging ≥10 drinks per day of drinking), and 2. Gender (male or female).

Timeline

Start

2020-02-01

Primary completion

2022-02-18

Completion

2022-03-18

Drugs

Indications