Oral Fluid Screening Devices | NCT00571207

Studies
Oral Fluid Screening Devices

NCT00571207

Sponsor

Finnish Institute for Health and Welfare

Status

Completed

Last Update Posted

Sep 2, 2011Estimated

Enrollment

250Estimated

Phase

Not provided

Conditions

Drug-impaired Driving

Interventions

On-site oral fluid screening devices
Checklist: drug recognition expert

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Not provided

Completion Date

Oct 2010Actual

First Submitted Date

Dec 10, 2007

First Submission Date that Met QC Criteria

Dec 10, 2007

First Posted Date

Dec 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2011

Last Update Posted Date

Sep 2, 2011Estimated

Name	Class
Hospital District of Helsinki and Uusimaa	OTHER
European Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

Retention

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I		Drivers suspected of driving under the influence of drugs	Device: On-site oral fluid screening devices Behavioral: Checklist: drug recognition expert
II		Drivers not suspected of driving under the influence of drugs	Device: On-site oral fluid screening devices Behavioral: Checklist: drug recognition expert

Interventions

Name	Type	Description	Arm Group Labels	Other Names
On-site oral fluid screening devices	Device	Comparison of screening device results to oral and/or blood sample results	I II

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Drivers of motorised vehicles
18 years or older
Willing to participate

Exclusion Criteria:

Younger than 18
Not willing to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pirjo Lillsunde, Dr	National Public Health Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Public Health Institute		Helsinki		00300	Finland