- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00570518
Alcohol and Other Psychoactive Substances in Road Traffic - a Case-control Study
DRUID Work Package 2 - Epidemiology
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland, 00300
- Recruiting
- National Public Health Institute
-
Contact:
- Pirjo Lillsunde, Dr
- Phone Number: +358947448342
- Email: pirjo.lillsunde@ktl.fi
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Contact:
- Charlotta Engblom, M.Sc.(Tech.)
- Phone Number: +358947448546
- Email: charlotta.engblom@ktl.fi
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Principal Investigator:
- Pirjo Lillsunde, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years or older
- driver of a motorised vehicle or bicycle
- is willing to participate to the study (not applicable to the diseased drivers; information obtained from a register database)
Exclusion Criteria:
- 17 or younger
- not the driver of a motorised vehicle or bicycle
- does not want to participate (not applicable to the diseased drivers; information obtained from a register database)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
1
randomly stopped drivers of motorised vehicles and bicycles
|
|
2
drivers of motorised vehicles and bicycles injured or killed in road traffic accidents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
relative risk estimation of accident involvement for drivers impaired by psychoactive substances
Time Frame: three years
|
three years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
prevalence of psychoactive substances in the general driving population
Time Frame: three years
|
three years
|
|
prevalence of psychoactive substances among accident involved drivers
Time Frame: three years
|
three years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pirjo Lillsunde, Dr, National Public Health Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KTL 403-2
- 404-3
- 405-9
- 406-5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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