NCT00570518

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 3, 2011

Status Verified

September 1, 2011

First QC Date

December 10, 2007

Last Update Submit

September 30, 2011

Conditions

Keywords

driving under the influencepsychoactive substancesroadside surveyshospital surveysaccident involvement risk estimation

Outcome Measures

Primary Outcomes (1)

  • relative risk estimation of accident involvement for drivers impaired by psychoactive substances

    three years

Secondary Outcomes (2)

  • prevalence of psychoactive substances in the general driving population

    three years

  • prevalence of psychoactive substances among accident involved drivers

    three years

Study Arms (2)

1

randomly stopped drivers of motorised vehicles and bicycles

2

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Public Health Institute

Helsinki, 00300, Finland

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Driving Under the Influence

Condition Hierarchy (Ancestors)

Criminal BehaviorBehaviorDangerous Behavior

Study Officials

  • Pirjo Lillsunde, Dr

    National Public Health Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pirjo Lillsunde, Dr

CONTACT

Charlotta Engblom, M.Sc.(Tech.)

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 11, 2007

Study Start

September 1, 2007

Study Completion

October 1, 2011

Last Updated

October 3, 2011

Record last verified: 2011-09

Locations