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
  Purpose

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 Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of collisions and traffic violations [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided by Utrecht Institute for Pharmaceutical Sciences

Additional 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
Study First Received: July 18, 2008
Last Updated: February 12, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:
STISIM
Alcohol

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

ClinicalTrials.gov processed this record on July 24, 2014