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Effects of Alcohol on Simulated Driving

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00477984
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : April 15, 2008
Information provided by:
Utrecht Institute for Pharmaceutical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment
Alcoholism Drug: alcohol

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effects of Five Dosages of Ethanol on Simulated Driving Performance and Event-Related Potentials
Study Start Date : May 2007
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
alcohol and placebo
Drug: alcohol
alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo
Other Name: alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo

Primary Outcome Measures :
  1. Primary parameter of the steering simulator is the standard deviation of the car from the center of the road (steering error). [ Time Frame: 5 testdays ]

Secondary Outcome Measures :
  1. Reaction speed after hearing the deviant target tone. Brain activity: ERPs of interest are the mismatch negativity (MMN), P3a, P3b, and reorienting negativity (RON) [ Time Frame: 5 testdays ]

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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): NCT00477984

Utrecht Institute for Pharmaceutical Sciences
Utrecht, Netherlands
Sponsors and Collaborators
Utrecht Institute for Pharmaceutical Sciences
Principal Investigator: Joris C Verster, PhD Utrecht Institute for Pharmaceutical Sciences
Study Director: Edmund R Volkerts, PhD Utrecht Institute for Pharmaceutical Sciences

Responsible Party: Joris Verster, Utrecht University
ClinicalTrials.gov Identifier: NCT00477984     History of Changes
Other Study ID Numbers: 06-221/O
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: April 15, 2008
Last Verified: April 2008

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
social drinkers

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs