Pharmacogenetics of Alcohol: Treatment Implications
Subjective and Physiological Effects of Alcohol: Role of Genetic Variation and Adrenal Hormones
3 other identifiers
interventional
94
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 31, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
March 27, 2012
CompletedMarch 28, 2012
March 1, 2012
3.6 years
July 31, 2008
October 27, 2011
March 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Breath Alcohol
Breath Alcohol level
40 minutes after beginning drink
BAES Sedation Response, Average of 6 Time Points
Biphasic Alcohol Effects Scale (BAES) Sedation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 sedation related questions regarding effects of alcohol. Total BAES sedation subscale score 0-70 with higher numbers indicating greater sedative effects of alcohol. \[Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.\]
40, 80, 120, 160, 210 and 240 minutes after start of drinking
BAES Stimulation Response, Average of 6 Time Points
Biphasic Alcohol Effects Scale (BAES)Simulation items - sum of subjective responses - 0(not at all)to 10 (extremely)- for 7 stimulation related questions regarding effects of alcohol. Total BAES stimulation subscale score 0-70 with higher numbers indicating greater stimulating effects of alcohol. \[Martin, C. S., M. Earleywine, R. E. Musty, M. W. Perrine and R. M. Swift (1993a). Development and validation of the Biphasic Alcohol Effects Scale. Alcohol Clin Exp Res 17(1): 140-6.\]
40, 80, 120, 160, 210 and 240 minutes after start of drinking
Secondary Outcomes (1)
Change in Serum 3a-androstanediol Glucuronide
Baseline (pre medication administration) and 2-4 days post-medication (alcohol session)
Study Arms (4)
Placebo medication + placebo alcohol
PLACEBO COMPARATORPlacebo Medication + 0.8 gr/kg Ethanol
EXPERIMENTAL4 mg Dutasteride + Placebo Alcohol
EXPERIMENTAL4 mg Dutasteride + 0.8 gr/kg Ethanol
EXPERIMENTALInterventions
4 mg dutasteride administered 2-4 days prior to ingestion of 0.8 mg/kg ethanol divided between three drinks consumed over 36 minutes
placebo medication administered 2-4 days prior to ingestion of 0.8 gr/kg ethanol divided between three drinks consumed over 36 minutes
4 mg dutasteride administered 2-4 days prior to ingestion of three drinks each containing 1 cc ethanol consumed over 36 minutes
placebo medication administered 2-4 days prior to ingestion of three drinks each containing 1 cc ethanol consumed over 36 minutes
Eligibility Criteria
You may qualify if:
- 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 \<32.5. Drinking history: All subjects must report at least one occasion in the prior month of drinking at least 3 drinks on a single day; additionally, LD subjects will be selected if they drink 1-3 drinks, 1-3 times per week (up to 5 drinks per week on average), with no more than one occasion in the past 2 months on which they drank \>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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UConn Healthlead
- National Institutes of Health (NIH)collaborator
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)collaborator
Study Sites (1)
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan Covault
- Organization
- University of Connecticut Health Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Covault, MD, PhD
UConn Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 31, 2008
First Posted
August 14, 2008
Study Start
March 1, 2007
Primary Completion
October 1, 2010
Study Completion
July 1, 2011
Last Updated
March 28, 2012
Results First Posted
March 27, 2012
Record last verified: 2012-03