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

This study has been completed.
Sponsor:
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: November 1, 2013
Last verified: November 2013
  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.


Enrollment: 300
Study Start Date: May 2008
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650130

Locations
Finland
National Public Health Institute
Helsinki, Finland
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: November 1, 2013
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 July 29, 2014