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Calibration and Validation of the STISIM Driving Simulator

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ClinicalTrials.gov Identifier: NCT00720551
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : February 13, 2009
Sponsor:
Information provided by:
Utrecht Institute for Pharmaceutical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Simulated Driving Performance Other: alcohol Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Intervention Details:
    Other: alcohol
    alcohol 0.05%, 0.08% or 0.11% or placebo


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

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720551


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. J.C. Verster, Utrecht University
ClinicalTrials.gov Identifier: NCT00720551     History of Changes
Other Study ID Numbers: 07-374
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: February 2009

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
STISIM
Alcohol

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs