Alcohol Intoxication Clinical Trial
Official title:
Neurosteroids and Acute Alcohol Intoxication in Humans
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.
Status | Active, not recruiting |
Enrollment | 92 |
Est. completion date | March 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Behavioural Measures of Alcohol Intoxication, such as the Weingartner Verbal Memory Test, and the BVMT-R Visual Memory Test. | Behavioural measures are assessed within 2 hours of alcohol administration. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04230460 -
Cannabis Impairment Detection Application (CIDA)
|
N/A | |
Terminated |
NCT04192448 -
Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression
|
N/A | |
Completed |
NCT00515294 -
Acute and Residual Effects of Caffeinated Beer
|
Phase 2 | |
Recruiting |
NCT05779774 -
WayToServePlus: Improving Responsible Alcohol Service Ph II
|
N/A | |
Completed |
NCT03449095 -
Understanding Alcohol Reward in Social Context
|
N/A | |
Completed |
NCT02861807 -
Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking
|
N/A | |
Completed |
NCT01688245 -
A Text Message Behavioral Intervention to Reduce Alcohol Consumption in Young Adults
|
N/A | |
Completed |
NCT01783223 -
Prevalence of Chronic Inebriates to the Emergency Department and Suitability for Sobering House Services
|
||
Completed |
NCT05028413 -
Evaluating Perceived Fitness to Drive While Intoxicated
|
N/A | |
Not yet recruiting |
NCT06419647 -
Tracking Mood: The Effects of Daily Mood Tracking VAS on Alcohol Consumption in Adult Heavy Drinkers
|
N/A | |
Recruiting |
NCT05701865 -
Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention
|
N/A | |
Recruiting |
NCT05757089 -
Efficacy of the Dietary Food Supplement ALCOFILTRUM in Alleviating Alcohol Hangover Symptoms
|
N/A | |
Recruiting |
NCT04912492 -
Promoting Prosocial Bystander Behavior in Intoxicated Men: Evaluation of RealConsent2.0
|
N/A | |
Active, not recruiting |
NCT04564599 -
The Rise of Ride Sharing Companies and Trends in Impaired Driving Accidents
|
||
Not yet recruiting |
NCT04229732 -
Trials of Ventilation Assisted Substance Elimination Via the Lung - Ethanol (VASEL - Ethanol)
|
N/A | |
Recruiting |
NCT06065657 -
Effect of Nutritional Ketosis on Alcohol Metabolism
|
Phase 2/Phase 3 | |
Recruiting |
NCT03242161 -
Development of LabPatch-alcohol as a Noninvasive Skin Patch to Detect Blood Alcohol Concentrations
|
Early Phase 1 | |
Recruiting |
NCT04931095 -
The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
|
Phase 1 | |
Active, not recruiting |
NCT03467191 -
Behavioral Alcohol Responses (BAR) Study
|
Early Phase 1 | |
Recruiting |
NCT06264791 -
Stress-motivated Alcohol Use as a Value-based Decision-making Process
|
N/A |