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Effects of Alcohol on Simulated Driving

This study has been completed.
Sponsor:
Information provided by:
Utrecht Institute for Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00477984
First received: May 23, 2007
Last updated: April 11, 2008
Last verified: April 2008
History of Changes
  Purpose

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 Intervention
Alcoholism
 Drug: alcohol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The Effects of Five Dosages of Ethanol on Simulated Driving Performance and Event-Related Potentials

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism
U.S. FDA Resources

Further study details as provided by Utrecht Institute for Pharmaceutical Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477984

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

No publications provided

Responsible Party: Joris Verster, Utrecht University
ClinicalTrials.gov Identifier: NCT00477984     History of Changes
Other Study ID Numbers: 06-221/O
Study First Received: May 23, 2007
Last Updated: April 11, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
Alcohol
Driving
Multitasking
ERP
social drinkers

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013