Status:
COMPLETED
Calibration and Validation of the STISIM Driving Simulator
Lead Sponsor:
Utrecht Institute for Pharmaceutical Sciences
Conditions:
Simulated Driving Performance
Eligibility:
All Genders
21-50 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00720551
Start Date
June 1 2008
End Date
February 1 2009
Last Update
February 13 2009
Active Locations (1)
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1
Utrecht University, Section Psychopharmacology
Utrecht, Netherlands, 3508 TB