Whole Blood-plasma-oral Fluid Ratios of Psychoactive Drugs and Medicines
This study is currently recruiting participants.
Verified September 2011 by National Institute for Health and Welfare, Finland
Sponsor:
National Institute for Health and Welfare, Finland
Collaborators:
Helsinki University
Ministry of Internal Affairs, Finland
European Commission
Information provided by (Responsible Party):
National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT00650130
First received: March 27, 2008
Last updated: September 30, 2011
Last verified: September 2011
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Purpose
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 |
|---|
|
Driving Under the Influence |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control |
| Official Title: | DRUID Sub-study: Substance Concentration Ratio/Impairment |
Further study details as provided by National Institute for Health and Welfare, Finland:
Primary Outcome Measures:
- ratio of psychoactive drugs/medicines in whole blood-plasma-saliva and correlation to symptoms of impairment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- prevalence of psychoactive substances in the general driving population [ Time Frame: three years ] [ Designated as safety issue: Yes ]
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.
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | October 2011 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
drivers of motorised vehicles suspected of being under the influence of psychoactive drugs
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
drivers of motorised vehicles in general road traffic
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650130
Contacts
| Contact: Pirjo Lillsunde, Dr | +358947448342 | pirjo.lillsunde@ktl.fi |
| Contact: Charlotta Engblom, M.Sc.(Tech.) | +358947448546 | charlotta.engblom@ktl.fi |
Locations
| Finland | |
| National Public Health Institute | Recruiting |
| Helsinki, Finland | |
| Contact: Pirjo Lillsunde, Dr +358947448342 pirjo.lillsunde@ktl.fi | |
| Contact: Charlotta Engblom, M.Sc.(Tech.) +358947448546 charlotta.engblom@ktl.fi | |
| Principal Investigator: Pirjo Lillsunde, Dr | |
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Helsinki University
Ministry of Internal Affairs, Finland
European Commission
Investigators
| Principal Investigator: | Pirjo Lillsunde, Dr | National Public Health Institute, Helsinki, Finland |
More Information
Additional Information:
No publications provided
| Responsible Party: | National Institute for Health and Welfare, Finland |
| ClinicalTrials.gov Identifier: | NCT00650130 History of Changes |
| Other Study ID Numbers: | KTL 417-7 |
| Study First Received: | March 27, 2008 |
| Last Updated: | September 30, 2011 |
| Health Authority: | Finland: Ministry of Social Affairs and Health Finland: Ethics Committee |
Keywords provided by National Institute for Health and Welfare, Finland:
|
driving under the influence psychoactive substances oral fluid whole blood |
plasma Ratio of psychoactive substances in whole blood-plasma-oral fluid Prevalence of psychoactive substances in road traffic |
Additional relevant MeSH terms:
|
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013