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 gender and level of alcohol consumption prior to enrollment in the study

NCT04101227

Conditions

1. Alcohol Use Disorder

Interventions

1. Drug: AD04 (ondansetron)
2. Drug: Matching placebo
3. Device: Companion Diagnostic for Genetic Testing
4. Behavioral: Brief Psychological Counseling

MeSH:Alcoholism Alcohol Drinking

The blood sample collected for DNA testing contains at least one of the following genotypes as measured by Adial's validated method: - rs4795541-LL genotype of the insertion-deletion polymorphism (5'-HTTLPR) in the 5'-regulatory region and rs1042173-TT SNP in the 3'-untranslated region of SLC6A4 gene that encodes the serotonin transporter - rs1150226-AG SNP in HTR3A, the gene that encodes subtype A of the serotonin-3 receptor - rs1176713-GG SNP in HTR3A, the gene that encodes subtype A of the serotonin-3 receptor - rs17614942-AC in HTR3B, the gene that encodes subtype B of the serotonin-3 receptor 8. Expressed a wish to reduce or stop alcohol consumption.

>6/day or more heavy alcohol consumption in the 4 weeks preceding the screening visit), and have selected genotypes (LL/TT genotype and/or 1, 2 or 3 of the SNPs on the genes for the 5-HT3 receptor subunits: rs1150226-AG or rs1176713-GG in the gene that encodes the 5-HT3A receptor subunit, and rs17614942-AC in the gene that encodes the 5-HT3B receptor subunit), and who are eligible to participate in the study based on meeting the remaining study inclusion/exclusion criteria.