NCT00650130

Brief Summary

The aim of this study is to get new information on the whole blood-plasma-oral fluid ratios of psychoactive drugs which are encountered in traffic. Samples are taken from drivers suspected of being under the influence of drugs or medicines. The samples are analysed with immunological methods and GC-MS. Observations from Police and a physician on impairment are combined with the results of the different bodily fluids. Observational evaluations and substance concentrations are compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 4, 2013

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

March 27, 2008

Last Update Submit

November 1, 2013

Conditions

Driving Under the Influence

Keywords

driving under the influencepsychoactive substancesoral fluidwhole bloodplasmaRatio of psychoactive substances in whole blood-plasma-oral fluidPrevalence of psychoactive substances in road traffic

Outcome Measures

Primary Outcomes (1)

  • ratio of psychoactive drugs/medicines in whole blood-plasma-saliva and correlation to symptoms of impairment

    1 year

Secondary Outcomes (1)

  • prevalence of psychoactive substances in the general driving population

    three years

Study Arms (1)

1

drivers of motorised vehicles suspected of being under the influence of psychoactive drugs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

drivers of motorised vehicles in general road traffic

You may qualify if:

  • years or older
  • driver of a motorised vehicle

You may not qualify if:

  • years or younger
  • not the driver of a motorised vehicle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Public Health Institute

Helsinki, Finland

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and oral fluid are collected for the study. However no DNA detection is done at any stage. The laboratory where samples are analysed do not analyse DNA. DNA is not relevant to this study.

MeSH Terms

Conditions

Driving Under the Influence

Condition Hierarchy (Ancestors)

Criminal BehaviorBehaviorDangerous Behavior

Study Officials

  • Pirjo Lillsunde, Dr

    National Public Health Institute, Helsinki, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 1, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2008

Study Completion

October 1, 2011

Last Updated

November 4, 2013

Record last verified: 2013-11

Locations

FI(1)