SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT00831272

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Pharmacogenetic Response to Naltrexone for Alcohol Dependence

The aims of the study are to test for treatment outcome differences in alcohol dependent subjects randomly assigned to 12 weeks of treatment with NTX (50mg/day) or placebo among those with one or two copies of the Asp40 allele of the mu-opioid receptor compared to those homozygous for the Asn40 allele. Thus, the design of the study is a 2X2 cell double-blind randomization to NTX or placebo stratified by genotype. To meet these aims, 150 alcohol dependent outpatients with one or two copies of the Asp40 variant of the mu-opioid receptor and 190 subjects homozygous for the Asn40 variant will be recruited across the four participating sites.

NCT00831272 Alcohol Dependence
MeSH:Alcoholism

2 Interventions

Name: naltrexone

Description: 50mg/day
Type: Drug
Group Labels: 1

Naltrexone

Name: Placebo

Description: Placebo
Type: Drug
Group Labels: 1

Placebo


Primary Outcomes

Measure: Clinical Response to Naltrexone, as Measured by a Reduction in the Percent Days of Heavy Drinking Days (as Defined by >5 Drinks/Day for Males; >4 for Females) During the 12 Weeks of the Trial.

Time: 12 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 A118G

Recent work at our center provides evidence that the mu-opioid receptor (OPRM1) gene polymorphism A118G (Asn40Asp) imparts a significant change in treatment response. --- A118G ---

To further consolidate our knowledge, we wish to test the relationship between A118G polymorphism and the response to treatment with naltrexone. --- A118G ---

This work is focused on subjects of European or Asian descent as the A118G polymorphism occurs in less than 1% of those of African descent. --- A118G ---


2 N40D

Recent work at our center provides evidence that the mu-opioid receptor (OPRM1) gene polymorphism A118G (Asn40Asp) imparts a significant change in treatment response. --- A118G --- --- Asn40Asp ---

Based upon these very promising findings, the aim of this study is to examine prospectively the interaction between a functional polymorphism of the mu-opioid receptor (A+118G (Asn40Asp)) and response to treatment with naltrexone. --- Asn40Asp ---



HPO Nodes