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Calibration and Validation of the STISIM Driving Simulator

This study has been completed.
Information provided by:
Utrecht Institute for Pharmaceutical Sciences Identifier:
First received: July 18, 2008
Last updated: February 12, 2009
Last verified: February 2009
The aim of this study is to calibrate the STISIM driving simulator under influence of three different dosages of ethanol (0.05%, 0.08% and 0.11% BAC). The levels of performance decrement for the three blood alcohol concentrations will serve as a standard for comparing the effects that will be observed with psychoactive drugs in future trials. This will make the results of these future studies more easily to interpret and will provide health care providers and policy makers who read our scientific work with an easy-to-understand and clinically relevant comparison.

Condition Intervention
Simulated Driving Performance Other: alcohol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Calibration and Validation of the STISIM Driving Simulator: Simulated Driving Performance Under the Influence of Alcohol (0.05%, 0.08% AND 0.11%), and Placebo

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

Primary Outcome Measures:
  • Standard Deviation of the Lateral Position (SDLP) [ Time Frame: one day ]

Secondary Outcome Measures:
  • Number of collisions and traffic violations [ Time Frame: 20 minutes ]

Enrollment: 27
Study Start Date: June 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: alcohol
    alcohol 0.05%, 0.08% or 0.11% or placebo

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

Inclusion Criteria:

  • 21-50 years old
  • Written informed consent
  • Normal static binocular acuity, corrected or uncorrected
  • Normal hearing
  • Social Drinker (average of 7 to 21 alcoholic drinks per week and experience with drinking 4-6 drinks per occasion)
  • No current or past drug use
  • Possession of a driver's license for at least 3 years
  • Be considered as reliable and mentally capable of adhering to the protocol

Exclusion Criteria:

  • Current and past drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
  • Positive urine pregnancy screen in women
  • Present use of psychoactive medication
  • Positive alcohol breath test
  • Prior enrollment 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
  • Simulator sickness, as determined during the training session
  Contacts and Locations
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Please refer to this study by its identifier: NCT00720551

Utrecht University, Section Psychopharmacology
Utrecht, Netherlands, 3508 TB
Sponsors and Collaborators
Utrecht Institute for Pharmaceutical Sciences
Principal Investigator: Joris C Verster, PhD Utrecht University
Study Director: Lieke M de Senerpont Domis, MSc Utrecht University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. J.C. Verster, Utrecht University Identifier: NCT00720551     History of Changes
Other Study ID Numbers: 07-374
Study First Received: July 18, 2008
Last Updated: February 12, 2009

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on September 20, 2017