Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-02 @ 10:25 PM
Study NCT ID:
NCT00570518
Status:
UNKNOWN
Last Update Posted:
2011-10-03
First Post:
2007-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alcohol and Other Psychoactive Substances in Road Traffic - a Case-control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-12-23', 'releaseDate': '2013-11-01'}, {'resetDate': '2018-08-17', 'releaseDate': '2017-11-17'}, {'resetDate': '2021-02-01', 'releaseDate': '2021-01-13'}], 'estimatedResultsFirstSubmitDate': '2013-11-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000066448', 'term': 'Driving Under the Influence'}], 'ancestors': [{'id': 'D000066479', 'term': 'Criminal Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003617', 'term': 'Dangerous Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood and oral fluid are collected for the study. However, no DNA determinations are done at any point of the study. The laboratory where the samples are analysed does not analyse DNA. DNA is not relevant for this study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-09-30', 'studyFirstSubmitDate': '2007-12-10', 'studyFirstSubmitQcDate': '2007-12-10', 'lastUpdatePostDateStruct': {'date': '2011-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relative risk estimation of accident involvement for drivers impaired by psychoactive substances', 'timeFrame': 'three years'}], 'secondaryOutcomes': [{'measure': 'prevalence of psychoactive substances in the general driving population', 'timeFrame': 'three years'}, {'measure': 'prevalence of psychoactive substances among accident involved drivers', 'timeFrame': 'three years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['driving under the influence', 'psychoactive substances', 'roadside surveys', 'hospital surveys', 'accident involvement risk estimation'], 'conditions': ['Prevalence of Psychoactive Substances in Road Traffic', 'Psychoactive Substances in Accident Involved Drivers', 'Relative Risk Estimation of Accident Involvement for Impaired Drivers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.druid-project.eu', 'label': 'The official homepage of the EU-project'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to determine the accident risk when driving under the influence of psychoactive substances, including alcohol (DUI). Other aims are to find out the prevalence of psychoactive substances in road traffic and to obtain information on the role of these substances in road traffic accident causations.\n\nFor the purposes of the study, drivers of motorised vehicles are randomly stopped and interviewed and breath alcohol is recorded. Also, an oral fluid sample is taken and psychoactive substances are investigated in the laboratory. For cases, drivers injured in traffic accidents are asked to participate to the study. A whole blood sample and, if possible, an oral fluid sample is taken and psychoactive substances are determined in the laboratory. Also, people diseased in road traffic accident are included in the study. The information required for these subjects are taken from a register database.\n\nThe study is part of an EU-project DRUID. Altogether 13 European countries take part to the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'drivers of motorised vehicles and bicycles in general road traffic or drivers of motorised vehicles and bicycles, injured or killed in road traffic accidents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* driver of a motorised vehicle or bicycle\n* is willing to participate to the study (not applicable to the diseased drivers; information obtained from a register database)\n\nExclusion Criteria:\n\n* 17 or younger\n* not the driver of a motorised vehicle or bicycle\n* does not want to participate (not applicable to the diseased drivers; information obtained from a register database)'}, 'identificationModule': {'nctId': 'NCT00570518', 'briefTitle': 'Alcohol and Other Psychoactive Substances in Road Traffic - a Case-control Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Finnish Institute for Health and Welfare'}, 'officialTitle': 'DRUID Work Package 2 - Epidemiology', 'orgStudyIdInfo': {'id': 'KTL 403-2'}, 'secondaryIdInfos': [{'id': '404-3'}, {'id': '405-9'}, {'id': '406-5'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'randomly stopped drivers of motorised vehicles and bicycles'}, {'label': '2', 'description': 'drivers of motorised vehicles and bicycles injured or killed in road traffic accidents'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00300', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Pirjo Lillsunde, Dr', 'role': 'CONTACT', 'email': 'pirjo.lillsunde@ktl.fi', 'phone': '+358947448342'}, {'name': 'Charlotta Engblom, M.Sc.(Tech.)', 'role': 'CONTACT', 'email': 'charlotta.engblom@ktl.fi', 'phone': '+358947448546'}, {'name': 'Pirjo Lillsunde, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Public Health Institute', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Pirjo Lillsunde, Dr', 'role': 'CONTACT', 'email': 'pirjo.lillsunde@ktl.fi', 'phone': '+358947448342'}, {'name': 'Charlotta Engblom, M.Sc.(Tech.)', 'role': 'CONTACT', 'email': 'charlotta.engblom@ktl.fi', 'phone': '+358947448546'}], 'overallOfficials': [{'name': 'Pirjo Lillsunde, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Public Health Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hospital District of Helsinki and Uusimaa', 'class': 'OTHER'}, {'name': 'European Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-11-01', 'type': 'RELEASE'}, {'date': '2013-12-23', 'type': 'RESET'}, {'date': '2017-11-17', 'type': 'RELEASE'}, {'date': '2018-08-17', 'type': 'RESET'}, {'date': '2021-01-13', 'type': 'RELEASE'}, {'date': '2021-02-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Finnish Institute for Health and Welfare'}}}}