Pharmacogenetics of Alcohol: Treatment Implications
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
Outcome
Mixed primary results
registry analysis (superiority or other test); Placebo Medication + 0.8 gr/kg Ethanol vs 4 mg Dutasteride + 0.8 mg/kg Ethanol; p = 0.010; Mixed Models Analysis NCT00734656 ↗
registry MEAN Placebo Medication + 0.8 gr/kg Ethanol: 8.9 (Standard Error 0.6) units on a scale NCT00734656 ↗
registry MEAN 4 mg Dutasteride + 0.8 mg/kg Ethanol: 7.4 (Standard Error 0.5) units on a scale NCT00734656 ↗
registry analysis (superiority or other test); Placebo Medication + 0.8 gr/kg Ethanol vs 4 mg Dutasteride + 0.8 mg/kg Ethanol; p = 0.28; t-test, 2 sided NCT00734656 ↗
registry analysis (superiority or other test); Placebo Medication + 0.8 gr/kg Ethanol vs 4 mg Dutasteride + 0.8 mg/kg Ethanol; p = 0.17; Mixed Models Analysis NCT00734656 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dutasteride | Small molecule | 4 mg | — |
| Subject | Ethanol | Other / unclassified | 0.8 mg/kg | — |
| Subject | Ethanol | Other / unclassified | 1 ml | — |