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Effects of Alcohol on Simulated Driving

NCT ID: NCT00477984

Last Updated: 2008-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-03-31

Brief Summary

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Previous studies have shown that alcohol significantly impairs driving performance. Acute alcohol administration also has a detrimental effect on secondary task performance during dual-tasks. The present study will investigate the effects of five different dosages of ethanol (0,0.2, 0,5, 0,8 and 1,0 % BAC) on performance in a driving simulator. Steering performance and brain activity will be recorded in both single- and dual-task conditions.

Detailed Description

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Conditions

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Alcoholism

Keywords

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Alcohol Driving Multitasking ERP social drinkers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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A

alcohol and placebo

Group Type EXPERIMENTAL

alcohol

Intervention Type DRUG

alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo

Interventions

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alcohol

alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo

Intervention Type DRUG

Other Intervention Names

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alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo

Eligibility Criteria

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Inclusion Criteria

* He/she is aged between 21-50
* Written informed consent
* Right-handed
* Normal static binocular acuity, corrected or uncorrected
* Normal hearing
* Social Drinker (average of 7 to 21 alcoholic drinks per week)
* Possession of a drivers license
* Be considered as reliable and mentally capable of adhering to the protocol.

Exclusion Criteria

* Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
* Positive urine pregnancy drug screen in women
* Use of psychoactive medication
* Positive alcohol breath test
* Prior enrolment in the same study
* Physical or mental illness
* Excessive alcohol use (\>21 alcoholic drinks per week)
* Excessive smoking (more than 10 cigarettes per day)
* Intake of caffeine-containing beverages over 5 glasses per day
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Utrecht Institute for Pharmaceutical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Utrecht University

Principal Investigators

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Joris C Verster, PhD

Role: PRINCIPAL_INVESTIGATOR

Utrecht Institute for Pharmaceutical Sciences

Edmund R Volkerts, PhD

Role: STUDY_DIRECTOR

Utrecht Institute for Pharmaceutical Sciences

Locations

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Utrecht Institute for Pharmaceutical Sciences

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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06-221/O

Identifier Type: -

Identifier Source: org_study_id