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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Ethanol
Anti-Infective Agents
Anti-Infective Agents, Local
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014