Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Neurosteroids and Acute Alcohol Intoxication in Humans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00608686
First received: January 26, 2008
Last updated: December 18, 2008
Last verified: December 2008
History of Changes
  Purpose

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 Intervention Phase
Alcohol Intoxication
 Dietary Supplement: Pregnenolone
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Neurosteroids and Acute Alcohol Intoxication in Humans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
Estimated Enrollment: 92
Study Start Date: May 2004
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Pregnenolone
    30mg of pregnenolone administered orally, once, at 2 of 5 study visits.
  Show Detailed Description

  Eligibility
Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 26, 2008
Last Updated: December 18, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Alcoholic Intoxication
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on February 27, 2015