Calibration and Validation of the STISIM Driving Simulator
This study has been completed.
Sponsor:
Utrecht Institute for Pharmaceutical Sciences
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 18, 2008 | ||||||||
| Last Updated Date | February 12, 2009 | ||||||||
| Start Date ICMJE | June 2008 | ||||||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Standard Deviation of the Lateral Position (SDLP) [ Time Frame: one day ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Standard Deviation of the Lateral Position (SDLP) [ Time Frame: 100 km ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT00720551 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Number of collisions and traffic violations [ Time Frame: 20 minutes ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Calibration and Validation of the STISIM Driving Simulator | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) |
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| Condition ICMJE | Simulated Driving Performance | ||||||||
| Intervention ICMJE | Other: alcohol
alcohol 0.05%, 0.08% or 0.11% or placebo |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 27 | ||||||||
| Completion Date | February 2009 | ||||||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 21 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00720551 | ||||||||
| Other Study ID Numbers ICMJE | 07-374 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. J.C. Verster, Utrecht University | ||||||||
| Study Sponsor ICMJE | Utrecht Institute for Pharmaceutical Sciences | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Utrecht Institute for Pharmaceutical Sciences | ||||||||
| Verification Date | February 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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