Calibration and Validation of the STISIM Driving Simulator
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 18, 2008
CompletedFirst Posted
Study publicly available on registry
July 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFebruary 13, 2009
February 1, 2009
8 months
July 18, 2008
February 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Standard Deviation of the Lateral Position (SDLP)
one day
Secondary Outcomes (1)
Number of collisions and traffic violations
20 minutes
Interventions
alcohol 0.05%, 0.08% or 0.11% or placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Utrecht University, Section Psychopharmacology
Utrecht, 3508 TB, Netherlands
Related Publications (1)
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.
PMID: 21823173DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joris C Verster, PhD
Utrecht University
- STUDY DIRECTOR
Lieke M de Senerpont Domis, MSc
Utrecht University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 18, 2008
First Posted
July 22, 2008
Study Start
June 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
February 13, 2009
Record last verified: 2009-02