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Neurosteroids and Acute Alcohol Intoxication in Humans

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ClinicalTrials.gov Identifier: NCT00608686
Recruitment Status : Unknown
Verified December 2008 by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Recruitment status was:  Active, not recruiting
First Posted : February 6, 2008
Last Update Posted : December 19, 2008
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Description
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Brief Summary:

1. The major aims are to assess: (1) the relationship of basal and alcohol-induced neurosteroid and GABA levels to the degree of acute alcohol intoxication in healthy male and female volunteers; and (2) the effect of acute pregnenolone administration on the degree of acute alcohol intoxication in these same volunteers. Specific hypotheses are:

  • Baseline serum levels of pregnenolone, pregnenolone sulfate (PS), dehydroepiandrosterone (DHEA) and DHEA sulfate (DHEA-S) will be inversely correlated with the magnitude of acute behavioral responses to alcohol (sedation, anxiolysis, amnesia, psychomotor impairment and intoxication). That is, higher baseline levels of these neurosteroids will be associated with lessened behavioral responses to alcohol.
  • Baseline serum levels of allopregnanolone, tetrahydrodeoxycorticosterone (THDOC), androstanediol, androsterone and GABA will be directly correlated with the magnitude of acute behavioral responses to alcohol. That is, higher baseline levels of these substances will be associated with heightened behavioral responses to alcohol.
  • Acute alcohol ingestion, compared to placebo ingestion, will increase serum levels of allopregnanolone and THDOC and plasma levels of GABA and will decrease plasma levels of PS. (Effects on levels of other neurosteroids are not specifically predicted based on animal data but will be examined in an exploratory manner.)
  • Acute alcohol-induced increases in serum levels of allopregnanolone and THDOC and in plasma levels of GABA will be directly correlated with the magnitude of acute behavioral responses to alcohol. Acute alcohol-induced decreases in serum levels of PS will be directly correlated with the magnitude of acute behavioral responses to alcohol. Correlations between alcohol-induced changes in other neurosteroids and changes in behavior are not specifically predicted but will be examined in an exploratory manner.
  • Pregnenolone, compared to placebo, pre-treatment will antagonize the acute effects of alcohol on the behavioral measures.

Condition or disease Intervention/treatment Phase
Alcohol Intoxication Dietary Supplement: Pregnenolone Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Neurosteroids and Acute Alcohol Intoxication in Humans
Study Start Date : May 2004
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Dietary Supplement: Pregnenolone
    30mg of pregnenolone administered orally, once, at 2 of 5 study visits.

Outcome Measures
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Primary Outcome Measures :
  1. Behavioural Measures of Alcohol Intoxication, such as the Weingartner Verbal Memory Test, and the BVMT-R Visual Memory Test. [ Time Frame: Behavioural measures are assessed within 2 hours of alcohol administration. ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • drinks alcohol more than 6 times a year.
  • can understand english well enough to perform the required tasks.
  • is in general good health.

Exclusion Criteria:

  • having a member of immediate family who is alcoholic.
  • using drugs that would interfere with study.
  • not able to tolerate 3 alcoholic drinks within 30 minutes.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608686


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
More Information
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Responsible Party: Owen Wolkowitz, MD, University of California, San Francisco, Dept. of Psychiatry
ClinicalTrials.gov Identifier: NCT00608686     History of Changes
Other Study ID Numbers: NIAAA-WOLKOWITZ-AA013929
NIH grant 5R01AA013929-04
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: December 19, 2008
Last Verified: December 2008

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
NIAAA
Alcohol
Neurosteroids
Intoxication

Additional relevant MeSH terms:
Alcoholic Intoxication
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
 Neurotransmitter Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action