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
Outcome
Missed primary endpoint
release “which resulted in us not achieving the primary efficacy analysis among the combined population.” reads as missed primary endpoint adial.com ↗
release “ONWARD results showed that AD04 achieved a statistically significant reduction of heavy drinking days in the “heavy drinkers” subgroup of patients.” reads as unknown adial.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ondansetron | Other / unclassified | 0.33 mg | Oral |