Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT00720551
Status:
COMPLETED
Last Update Posted:
2009-02-13
First Post:
2008-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Calibration and Validation of the STISIM Driving Simulator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-12', 'studyFirstSubmitDate': '2008-07-18', 'studyFirstSubmitQcDate': '2008-07-21', 'lastUpdatePostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard Deviation of the Lateral Position (SDLP)', 'timeFrame': 'one day'}], 'secondaryOutcomes': [{'measure': 'Number of collisions and traffic violations', 'timeFrame': '20 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['STISIM', 'Alcohol'], 'conditions': ['Simulated Driving Performance']}, 'referencesModule': {'references': [{'pmid': '21823173', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 21-50 years old\n* Written informed consent\n* Normal static binocular acuity, corrected or uncorrected\n* Normal hearing\n* Social Drinker (average of 7 to 21 alcoholic drinks per week and experience with drinking 4-6 drinks per occasion)\n* No current or past drug use\n* Possession of a driver's license for at least 3 years\n* Be considered as reliable and mentally capable of adhering to the protocol\n\nExclusion Criteria:\n\n* Current and past drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)\n* Positive urine pregnancy screen in women\n* Present use of psychoactive medication\n* Positive alcohol breath test\n* Prior enrollment in the same study\n* Physical or mental illness\n* Excessive alcohol use ( \\> 21 alcoholic drinks per week)\n* Excessive smoking (more than 10 cigarettes per day)\n* Intake of caffeine-containing beverages over 5 glasses per day\n* Simulator sickness, as determined during the training session"}, 'identificationModule': {'nctId': 'NCT00720551', 'briefTitle': 'Calibration and Validation of the STISIM Driving Simulator', 'organization': {'class': 'OTHER', 'fullName': 'Utrecht Institute for Pharmaceutical Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '07-374'}}, 'armsInterventionsModule': {'interventions': [{'name': 'alcohol', 'type': 'OTHER', 'description': 'alcohol 0.05%, 0.08% or 0.11% or placebo'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3508 TB', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Utrecht University, Section Psychopharmacology', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Joris C Verster, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Utrecht University'}, {'name': 'Lieke M de Senerpont Domis, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Utrecht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Utrecht Institute for Pharmaceutical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. J.C. Verster', 'oldOrganization': 'Utrecht University'}}}}