Oral Fluid Screening Devices

August 31, 2011 updated by: Finnish Institute for Health and Welfare

Scientific Evaluation of Oral Fluid Screening Devices and Preceding Selection Procedures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00300
        • National Public Health Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Younger than 18
  • Not willing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
scientific evaluation of the on-site oral fluid screening devices
Time Frame: three years
three years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Institute for Health and Welfare

Collaborators

European Commission
Hospital District of Helsinki and Uusimaa

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

August 31, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KTL 402-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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