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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 10, 2007 | ||||||||
| Last Updated Date | March 12, 2009 | ||||||||
| Start Date ICMJE | September 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
relative risk estimation of accident involvement for drivers impaired by psychoactive substances [ Time Frame: three years ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00570518 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Alcohol and Other Psychoactive Substances in Road Traffic - a Case-Control Study | ||||||||
| Official Title ICMJE | DRUID Work Package 2 - Epidemiology | ||||||||
| Brief Summary | 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. For 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. The study is part of an EU-project DRUID. Altogether 13 European countries take part to the study. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Other | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 4500 | ||||||||
| Estimated Completion Date | October 2010 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Finland | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00570518 | ||||||||
| Responsible Party | Pirjo Lillsunde, National Public Health Institute | ||||||||
| Study ID Numbers ICMJE | KTL 403-2, 404-3, 405-9, 406-5 | ||||||||
| Study Sponsor ICMJE | National Institute for Health and Welfare, Finland | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Institute for Health and Welfare, Finland | ||||||||
| Verification Date | March 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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