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.

Conditions

• Alcohol Related Disorders
• Alcoholism
• Alcohol Abuse

Interventions

DRUG

dutasteride + ethanol

4 mg dutasteride administered 2-4 days prior to ingestion of 0.8 mg/kg ethanol divided between three drinks consumed over 36 minutes

DRUG

placebo medication + ethanol

placebo medication administered 2-4 days prior to ingestion of 0.8 gr/kg ethanol divided between three drinks consumed over 36 minutes

DRUG

dutasteride + placebo alcohol

4 mg dutasteride administered 2-4 days prior to ingestion of three drinks each containing 1 cc ethanol consumed over 36 minutes

DRUG

placebo medication + placebo alcohol

placebo medication administered 2-4 days prior to ingestion of three drinks each containing 1 cc ethanol consumed over 36 minutes

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• UConn Health

  lead OTHER

Principal Investigators

• Jonathan Covault, MD, PhD · UConn Health

Study Design

Allocation

RANDOMIZED

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Max Age

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-03-31

Primary Completion

2010-10-31

Completion

2011-07-31

Countries

• United States

Study Locations