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Calibration and Validation of the STISIM Driving Simulator

This study has been completed.
Sponsor:
Information provided by:
Utrecht Institute for Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00720551
First received: July 18, 2008
Last updated: February 12, 2009
Last verified: February 2009

July 18, 2008
February 12, 2009
June 2008
February 2009   (final data collection date for primary outcome measure)
Standard Deviation of the Lateral Position (SDLP) [ Time Frame: one day ] [ Designated as safety issue: No ]
Standard Deviation of the Lateral Position (SDLP) [ Time Frame: 100 km ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00720551 on ClinicalTrials.gov Archive Site
Number of collisions and traffic violations [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Calibration and Validation of the STISIM Driving Simulator
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Simulated Driving Performance
Other: alcohol
alcohol 0.05%, 0.08% or 0.11% or placebo
Not Provided
Mets MA, Kuipers E, de Senerpont Domis LM, Leenders M, Olivier B, Verster JC. Effects of alcohol on highway driving in the STISIM driving simulator. Hum Psychopharmacol. 2011 Aug;26(6):434-9. doi: 10.1002/hup.1226. Epub 2011 Aug 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00720551
07-374
No
Dr. J.C. Verster, Utrecht University
Utrecht Institute for Pharmaceutical Sciences
Not Provided
Principal Investigator: Joris C Verster, PhD Utrecht University
Study Director: Lieke M de Senerpont Domis, MSc Utrecht University
Utrecht Institute for Pharmaceutical Sciences
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP