Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 10:03 AM
Study NCT ID:
NCT01595659
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2012-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000602592', 'term': 'nuclear passenger protein-1, S pombe'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2015-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2012-05-05', 'studyFirstSubmitQcDate': '2012-05-08', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risky driving in a simulator', 'timeFrame': 'within 1 hr after alcohol dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Risk', 'Young drivers', 'Alcohol', 'Passengers', 'Gender'], 'conditions': ['Accidents, Traffic']}, 'descriptionModule': {'briefSummary': "Among the many risk factors that contribute to young drivers' crash involvement, two are critical: peer passenger presence, which is unique to young drivers, and the influence of alcohol, a universal risk for drivers but one against which young drivers are most susceptible. Clarification of how passenger presence interacts with alcohol consumption to increase risk is needed. The impact of experimentally manipulated passenger characteristics and alcohol quantity on risky driving is observed using driving simulation and a random assignment experimental design with a sample of 18-21 year old male and female drivers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '21 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being 18 to 21 years of age (18 years old is the legal age for alcohol consumption in the province of Quebec)\n* past experirence with drinking at least 2 alcoholic beverages in one episode\n* having a provisional driving license\n* driving in the past 3 months\n\nExclusion Criteria:\n\n* health problem that contraindicates participation\n* pregnant or breastfeeding\n* signs of problem drinking\n* positive BAC or recent drug use measured at arrival'}, 'identificationModule': {'nctId': 'NCT01595659', 'briefTitle': 'Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Centre de recherche du Centre hospitalier universitaire de Sherbrooke'}, 'officialTitle': 'Influence of Alcohol and Peer Passengers on Risky Driving Behavior in Young Adults', 'orgStudyIdInfo': {'id': 'MOP-111034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'no alcohol and passenger', 'description': 'Blood alcohol concentration (BAC) = 0.00% and risk accepting or averse passenger', 'interventionNames': ['Behavioral: Passenger']}, {'type': 'EXPERIMENTAL', 'label': 'low alcohol dose and passenger', 'description': 'BAC = 0.02% and risk accepting or averse passenger', 'interventionNames': ['Behavioral: Passenger']}, {'type': 'EXPERIMENTAL', 'label': 'moderate alcohol dose and passenger', 'description': 'BAC = 0.05% and risk accepting or averse passenger', 'interventionNames': ['Behavioral: Passenger']}], 'interventions': [{'name': 'Passenger', 'type': 'BEHAVIORAL', 'description': 'Driving with risk accepting or risk averse passenger', 'armGroupLabels': ['low alcohol dose and passenger', 'moderate alcohol dose and passenger', 'no alcohol and passenger']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J4K 0A8', 'city': 'Longueuil', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Université de Sherbrooke', 'geoPoint': {'lat': 45.5152, 'lon': -73.46818}}], 'overallOfficials': [{'name': 'Marie Claude Ouimet, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre de recherche du Centre hospitalier universitaire de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Marie Claude Ouimet', 'investigatorAffiliation': 'Centre de recherche du Centre hospitalier universitaire de Sherbrooke'}}}}