At a glance
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Pharmacogenetic Response to Naltrexone for Alcohol Dependence
In Brief
A Phase 4 clinical trial evaluating naltrexone and Placebo for Alcohol Dependence. Completed, enrolled 221 participants across 4 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
50mg/day
Placebo