Whole Blood-plasma-oral Fluid Ratios of Psychoactive Drugs and Medicines
Sponsor
Finnish Institute for Health and Welfare (Other)
Overall Status
Completed
CT.gov ID
NCT00650130
Collaborator
University of Helsinki (Other), Ministry of Internal Affairs, Finland (Other), European Commission (Other)
300
1
41
7.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
300 participants
Observational Model:
Case-Control
Official Title:
DRUID Sub-study: Substance Concentration Ratio/Impairment
Study Start Date
:
May 1, 2008
Actual Primary Completion Date
:
Dec 1, 2008
Actual Study Completion Date
:
Oct 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 drivers of motorised vehicles suspected of being under the influence of psychoactive drugs |
Outcome Measures
Primary Outcome Measures
- ratio of psychoactive drugs/medicines in whole blood-plasma-saliva and correlation to symptoms of impairment [1 year]
Secondary Outcome Measures
- prevalence of psychoactive substances in the general driving population [three years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
18 years or older
-
driver of a motorised vehicle
Exclusion Criteria:
-
17 years or younger
-
not the driver of a motorised vehicle
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Public Health Institute | Helsinki | Finland |
Sponsors and Collaborators
- Finnish Institute for Health and Welfare
- University of Helsinki
- Ministry of Internal Affairs, Finland
- European Commission
Investigators
- Principal Investigator: Pirjo Lillsunde, Dr, National Public Health Institute, Helsinki, Finland
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Finnish Institute for Health and Welfare
ClinicalTrials.gov Identifier:
NCT00650130
Other Study ID Numbers:
- KTL 417-7
First Posted:
Apr 1, 2008
Last Update Posted:
Nov 3, 2013
Last Verified:
Nov 1, 2013
Keywords provided by Finnish Institute for Health and Welfare