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Oral Fluid Screening Devices

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00571207
First Posted: December 11, 2007
Last Update Posted: September 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hospital District of Helsinki and Uusimaa
European Commission
Information provided by (Responsible Party):
National Institute for Health and Welfare, Finland
  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 ]

Secondary Outcome Measures:
  • evaluation on the police checklist [ Time Frame: three years ]
  • the time consumption of the selection procedure as a whole (checklist + oral fluid screening) [ Time Frame: three years ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT00571207     History of Changes
Other Study ID Numbers: KTL 402-1
First Submitted: December 10, 2007
First Posted: December 11, 2007
Last Update Posted: September 2, 2011
Last Verified: August 2011

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