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NCT00650130 Clinical Trial

Whole Blood-plasma-oral Fluid Ratios of Psychoactive Drugs and Medicines

Driving Under the Influence Clinical Trial

Official title:
DRUID Sub-study: Substance Concentration Ratio/Impairment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00650130
Other study ID # KTL 417-7
Secondary ID
Status Completed
Phase N/A
First received March 27, 2008
Last updated November 1, 2013
Start date May 2008
Est. completion date October 2011

Study information
Verified date November 2013
Source National Institute for Health and Welfare, Finland
Contact n/a
Is FDA regulated No
Health authority Finland: Ministry of Social Affairs and HealthFinland: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date October 2011
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years or older

- driver of a motorised vehicle

Exclusion Criteria:

- 17 years or younger

- not the driver of a motorised vehicle

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

Locations
Country Name City State
Finland National Public Health Institute Helsinki

Sponsors (4)
Lead Sponsor Collaborator
National Institute for Health and Welfare, Finland European Commission, Helsinki University, Ministry of Internal Affairs, Finland

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary ratio of psychoactive drugs/medicines in whole blood-plasma-saliva and correlation to symptoms of impairment 1 year Yes
Secondary prevalence of psychoactive substances in the general driving population three years Yes
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