NCT00720551CompletedNot Applicable
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
Utrecht Institute for Pharmaceutical Sciences2 sites in 1 country27 target enrollmentStarted: June 1, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Standard Deviation of the Lateral Position (SDLP)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 50 Years (Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Standard Deviation of the Lateral Position (SDLP)
Time Frame: one day
Secondary Outcomes
- Number of collisions and traffic violations(20 minutes)
Investigators
Study Sites (2)
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