drugset / Trial / NCT00734656

Pharmacogenetics of Alcohol: Treatment Implications

NCT00734656

RandomizedFactorialQuadruple-blind

Summary

This study will explore the hypothesis that effects of alcohol are in part mediated by increased production of neuroactive steroids, which interact with GABAA-receptors. We propose to study non-dependent drinkers using a 4-session within-subjects design in which alcohol / placebo is paired with dutasteride / placebo pretreatment. Dutasteride is a 5-alpha steroid reductase (5AR) inhibitor that limits the production of dihydrotestosterone and the 5a-reduced neuroactive steroids allopregnanolone, pregnanolone and 3a,5a-androstanediol.

Timeline

Start
2007-03
Primary completion
2010-10
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Alcohol Other / unclassified 0.8 mg/kg
Subject Alcohol Other / unclassified 1 ml
Subject Dutasteride Small molecule 4 mg