Pharmacogenetics of Alcohol: Treatment Implications

Status Completed

Clinical Trial 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.

Clinical Trial Description

Alcohol has multiple pharmacological effects, though which of these effects relate to the risk of alcohol dependence is not clear. Animal studies indicate that the neuroactive steroid allopregnanolone is an alcohol-modulated endogenous agonist at GABAA receptors and that genetic variation in steroid 5a-reductase type I gene which generates neuroactive steroids, may moderate alcohol effects. To better define the role of neuroactive steroids we will conduct a laboratory study of non-alcohol dependent drinkers using a 4-session design in which alcohol/placebo beverage is paired with dutasteride/placebo pretreatment. Dutasteride, an inhibitor of both type I and type II 5a-reductase enzymes, blocks the production of 5a-reduced neuroactive steroids. This study will extend our preliminary findings with finasteride by including a) a placebo control for alcohol, b) a more specific inhibitor of both 5a-reductase isoenzymes, c) a larger group of subjects (including both light and heavy drinkers). ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00734656
Study type	Interventional
Source	University of Connecticut Health Center
Contact
Status	Completed
Phase	N/A
Start date	March 2007
Completion date	July 2011

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05054738` - CRP and S&A for Inpatient Veterans	N/A
Completed	`NCT02233738` - Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services	N/A
Completed	`NCT05877807` - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Completed	`NCT00000437` - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)	Phase 4
Completed	`NCT00536146` - The Stress-Hormone System in Alcohol-Dependent Subjects	N/A
Terminated	`NCT00890149` - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults	Phase 2
Completed	`NCT02179749` - Mifepristone Treatment of Alcohol Use Disorder	Phase 2
Completed	`NCT02939352` - The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues	Early Phase 1
Completed	`NCT01553136` - Varenicline Treatment of Alcohol Dependence in Smokers	Phase 2
Terminated	`NCT01408641` - Topiramate for Alcohol Use in Posttraumatic Stress Disorder	N/A
Completed	`NCT01389297` - Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery	N/A
Completed	`NCT00768508` - Combined Pharmacotherapies for Alcoholism	Phase 3
Completed	`NCT01113164` - Matching Genotypes and Serotonergic Medications for Alcoholism	Phase 1
Completed	`NCT01760785` - Valproate for Mood Swings and Alcohol Use Following Head Injury	N/A
Completed	`NCT00127231` - Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women	N/A
Terminated	`NCT02842528` - Cognitive Vulnerability Factors in Alcohol-dependence	N/A
Completed	`NCT00367575` - An Internet-based Intervention for Problem Drinking	N/A
Completed	`NCT00583440` - 12-step Facilitation for the Dually Diagnosed	Phase 1/Phase 2
Completed	`NCT00223639` - New Medications to Treat Alcohol Dependence	Phase 2
Completed	`NCT00167687` - Prazosin Alcohol Dependence IVR Study	Phase 4