Alcohol and Other Psychoactive Substances in Road Traffic - a Case-control Study

Sponsor
Finnish Institute for Health and Welfare (Other)
Overall Status
Unknown status
CT.gov ID
NCT00570518
Collaborator
Hospital District of Helsinki and Uusimaa (Other), European Commission (Other)
4,500
1
49
91.9

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
4500 participants
Observational Model:
Case-Control
Official Title:
DRUID Work Package 2 - Epidemiology
Study Start Date :
Sep 1, 2007
Anticipated Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
1

randomly stopped drivers of motorised vehicles and bicycles

2

drivers of motorised vehicles and bicycles injured or killed in road traffic accidents

Outcome Measures

Primary Outcome Measures

  1. relative risk estimation of accident involvement for drivers impaired by psychoactive substances [three years]

Secondary Outcome Measures

  1. prevalence of psychoactive substances in the general driving population [three years]

  2. prevalence of psychoactive substances among accident involved drivers [three years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Public Health Institute Helsinki Finland 00300

Sponsors and Collaborators

  • Finnish Institute for Health and Welfare
  • Hospital District of Helsinki and Uusimaa
  • European Commission

Investigators

  • Principal Investigator: Pirjo Lillsunde, Dr, National Public Health Institute

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Finnish Institute for Health and Welfare
ClinicalTrials.gov Identifier:
NCT00570518
Other Study ID Numbers:
  • KTL 403-2
  • 404-3
  • 405-9
  • 406-5
First Posted:
Dec 11, 2007
Last Update Posted:
Oct 3, 2011
Last Verified:
Sep 1, 2011

Study Results

No Results Posted as of Oct 3, 2011