Oral Fluid Screening Devices

This study has been completed.
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:
NCT00571207
First received: December 10, 2007
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

This research includes the evaluation of a checklist and on-site screening devices to pre-select drivers suspected of being drug-impaired. The reliability of a limited number of promising on-site screening devices will be investigated. The devices tested will have to be promising regarding both reliability and practicality. In addition to the scientific evaluation of the checklist and the oral fluid screening devices, the time consumption of the selection procedure as a whole (checklist + oral fluid screening) will be evaluated.

Outcome of the study will be recommendations for the roadside selection procedure of drivers suspected of drug-related impairment. The recommendations will concentrate on the reliability of the selection procedure.

The study is part of an EU project DRUID. Two other countries in Europe take part to this study along with Finland.


Condition Intervention
Drug-impaired Driving
Device: On-site oral fluid screening devices
Behavioral: Checklist: drug recognition expert

Study Type: Observational
Official Title: Scientific Evaluation of Oral Fluid Screening Devices and Preceding Selection Procedures

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

Primary Outcome Measures:
  • scientific evaluation of the on-site oral fluid screening devices [ Time Frame: three years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • evaluation on the police checklist [ Time Frame: three years ] [ Designated as safety issue: Yes ]
  • the time consumption of the selection procedure as a whole (checklist + oral fluid screening) [ Time Frame: three years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Oral fluid and whole blood are collected. However, no DNA testing will be carried out. The research focuses on drug and medicine concentrations in these matrices.


Estimated Enrollment: 250
Study Start Date: April 2008
Study Completion Date: October 2010
Groups/Cohorts Assigned Interventions
I
Drivers suspected of driving under the influence of drugs
Device: On-site oral fluid screening devices
Comparison of screening device results to oral and/or blood sample results
Behavioral: Checklist: drug recognition expert
Correlation of drug recognition expert observations to findings for drugs in non-suspected/suspected cases
II
Drivers not suspected of driving under the influence of drugs
Device: On-site oral fluid screening devices
Comparison of screening device results to oral and/or blood sample results
Behavioral: Checklist: drug recognition expert
Correlation of drug recognition expert observations to findings for drugs in non-suspected/suspected cases

  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 suspected of driving under the influence of drugs. Also drivers who are not suspected of driving under the influence.

Criteria

Inclusion Criteria:

  • Drivers of motorised vehicles
  • 18 years or older
  • Willing to participate

Exclusion Criteria:

  • Younger than 18
  • Not willing to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571207

Locations
Finland
National Public Health Institute
Helsinki, Finland, 00300
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: NCT00571207     History of Changes
Other Study ID Numbers: KTL 402-1
Study First Received: December 10, 2007
Last Updated: August 31, 2011
Health Authority: Finland: Ethics Committee
Finland: Ministry of Social Affairs and Health

Keywords provided by National Institute for Health and Welfare, Finland:
driving under the influence of drugs
on-site oral fluid screening devices
checklist

ClinicalTrials.gov processed this record on April 17, 2014