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Completed

NCT Number: NCT00477984

Effects of Alcohol on Simulated Driving

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Utrecht Institute for Pharmaceutical Sciences

Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alcohol

Drug

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

Other names: alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Utrecht Institute for Pharmaceutical Sciences

Other

Registry information

Official study title

The Effects of Five Dosages of Ethanol on Simulated Driving Performance and Event-Related Potentials

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 24, 2007
Registry last updated
Apr 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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