N/A
Completed N=94
Pharmacogenetics of Alcohol: Treatment Implications
Alcohol Related Disorders · Alcoholism · Alcohol Abuse
Source: ClinicalTrials.gov NCT00734656 ↗
Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Breath Alcohol — 0.001; 0.075; 0.001; 0.071 gr/dL — p=0.28
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breath Alcohol |
0.001; 0.075; 0.001; 0.071 | 0.28 |
| PRIMARY BAES Sedation Response, Average of 6 Time Points |
0.7; 8.9; 1.5; 7.4 | 0.010 sig |
| PRIMARY BAES Stimulation Response, Average of 6 Time Points |
0.7; 4.2; 1.7; 4.8 | 0.17 |
| SECONDARY Change in Serum 3a-androstanediol Glucuronide |
1.04; 1.11; 0.31; 0.31 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Main Study: Subjects will be healthy volunteers with or without parental history of alcoholism who are 21-45 years old and who have a BMI >18.5 and 4 drinks. HD subjects will be selected if they report drinking at least 10 drinks per week, with at least one episode per week of heavy drinking.
Exclusion Criteria
- Main Study: Subjects cannot have a current or past DSM-IV diagnosis of alcohol or drug dependence, current or past 24-months diagnosis of alcohol or drug abuse or another major psychiatric disorder, neurological illness, have had a hypersensitivity reaction to dutasteride, evidence of liver dysfunction, currently be using benzodiazepines, other psychotropic medications or medications that are known to influence steroid hormone levels or metabolism or modify the effects of alcohol. Nicotine-dependent subjects will be excluded to avoid the confounding effects of nicotine withdrawal during day-long laboratory sessions. Women are not allowed to participate. Subjects anticipating moving from the area during the period of their planned study participation will be excluded from study entry.
Data sourced from ClinicalTrials.gov (NCT00734656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.