SNPMiner Trials (Home Page)
Report for Clinical Trial NCT04101227
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of AD04 (Ondansetron) in Adults With Alcohol Use Disorder (AUD) and Selected Polymorphisms in the Serotonin Transporter and Receptor Genes
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 Alcohol Use Disorder MeSH:Alcoholism Alcohol Drinking
4 Interventions
Name: AD04 (ondansetron)
Name: Matching placebo
Name: Companion Diagnostic for Genetic Testing
Name: Brief Psychological Counseling
Primary Outcomes
Description: Change from baseline in the monthly number of (heavy) drinking days (HDD) during the last 8 weeks (weeks 16-24) of the 24-week treatment period, where (heavy) drinking is defined as the consumption of ≥ 60 g alcohol/day (if male) or ≥ 40 g alcohol/day (if female).
Measure: Change from baseline in the monthly number of (heavy) drinking days Time: Last 8 weeksSecondary Outcomes
Description: Change from baseline in total alcohol consumption (TAC), defined as the mean daily alcohol consumption expressed in g/day over the last 4 weeks of the 24-week treatment period
Measure: Change from baseline in total alcohol consumption (TAC) Time: Last 4 weeksDescription: Responder analysis based on the number of subjects with no risk (heavy) drinking.
Measure: Secondary (2) Time: Last 8 weeksPurpose: Treatment
Allocation: Randomized
Parallel Assignment
There are 5 SNPs
SNPs
1 rs1042173
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.
2 rs1150226
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.
3 rs1176713
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.
4 rs17614942
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.
5 rs4795541
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.