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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by National Institute for Health and Welfare, Finland.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hospital District of Helsinki and Uusimaa
European Commission
Information provided by (Responsible Party):
National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT00570518
First received: December 10, 2007
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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.


Condition
Prevalence of Psychoactive Substances in Road Traffic
Psychoactive Substances in Accident Involved Drivers
Relative Risk Estimation of Accident Involvement for Impaired Drivers

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: DRUID Work Package 2 - Epidemiology

Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • relative risk estimation of accident involvement for drivers impaired by psychoactive substances [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • prevalence of psychoactive substances in the general driving population [ Time Frame: three years ] [ Designated as safety issue: Yes ]
  • prevalence of psychoactive substances among accident involved drivers [ Time Frame: three years ] [ Designated as safety issue: Yes ]

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.


Estimated Enrollment: 4500
Study Start Date: September 2007
Estimated Study Completion Date: October 2011
Groups/Cohorts
1
randomly stopped drivers of motorised vehicles and bicycles
2
drivers of motorised vehicles and bicycles injured or killed in road traffic accidents

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570518

Contacts
Contact: Pirjo Lillsunde, Dr +358947448342 pirjo.lillsunde@ktl.fi
Contact: Charlotta Engblom, M.Sc.(Tech.) +358947448546 charlotta.engblom@ktl.fi

Locations
Finland
National Public Health Institute Recruiting
Helsinki, Finland, 00300
Contact: Pirjo Lillsunde, Dr    +358947448342    pirjo.lillsunde@ktl.fi   
Contact: Charlotta Engblom, M.Sc.(Tech.)    +358947448546    charlotta.engblom@ktl.fi   
Principal Investigator: Pirjo Lillsunde, Dr         
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Hospital District of Helsinki and Uusimaa
European Commission
Investigators
Principal Investigator: Pirjo Lillsunde, Dr National Public Health Institute
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT00570518     History of Changes
Other Study ID Numbers: KTL 403-2, 404-3, 405-9, 406-5
Study First Received: December 10, 2007
Last Updated: September 30, 2011
Health Authority: Finland: Ministry of Social Affairs and Health
Finland: Ethics Committee

Keywords provided by National Institute for Health and Welfare, Finland:
driving under the influence
psychoactive substances
roadside surveys
hospital surveys
accident involvement risk estimation

ClinicalTrials.gov processed this record on July 20, 2014