Driving Under the InfluenceNCT00650130
Whole Blood-plasma-oral Fluid Ratios of Psychoactive Drugs and Medicines
An observational study of Driving Under the Influence, run by Finnish Institute for Health and Welfare at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Driving Under the Influence
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- May 2008to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: drivers of motorised vehicles in general road traffic
Who may be able to join
- 18 years or older
- driver of a motorised vehicle
Who cannot join
- 17 years or younger
- not the driver of a motorised vehicle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DRUID Sub-study: Substance Concentration Ratio/Impairment
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.
- Conditions
- Driving Under the Influence
- Keywords
- 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
- Medical subject headings
- Driving Under the Influence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | drivers of motorised vehicles suspected of being under the influence of psychoactive drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
ratio of psychoactive drugs/medicines in whole blood-plasma-saliva and correlation to symptoms of impairment
Measured: 1 year
Secondary outcomes (1)
prevalence of psychoactive substances in the general driving population
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2008
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Driving Under the InfluenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- University of Helsinki, Ministry of Internal Affairs, Finland, European Commission
- Responsible party
- Sponsor
- Investigators
- Pirjo Lillsunde, Dr, Principal investigator, National Public Health Institute, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650130
- Sponsor's protocol ID
- KTL 417-7
- Status last verified
- Nov 2013
- First submitted
- 27 Mar 2008
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRUID Sub-study: Substance Concentration Ratio/Impairment
- ClinicalTrials.gov ID
- NCT00650130
- Acronym / sponsor ID
- KTL 417-7
- Conditions
- Driving Under the Influence
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- University of Helsinki, Ministry of Internal Affairs, Finland, European Commission
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –drivers of motorised vehicles suspected of being under the influence of psychoactive drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- drivers of motorised vehicles in general road traffic
Key inclusion criteria (2 listed)
- 18 years or older
- driver of a motorised vehicle
Key exclusion criteria (2 listed)
- 17 years or younger
- not the driver of a motorised vehicle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ratio of psychoactive drugs/medicines in whole blood-plasma-saliva and correlation to symptoms of impairment
Time frame: 1 year
1 secondary outcome
prevalence of psychoactive substances in the general driving population
Time frame: three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2013.
- Official home page of the EU-projectLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pirjo Lillsunde, Dr principal investigator
National Public Health Institute, Helsinki, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Driving Under the Influence, run by Finnish Institute for Health and Welfare at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ratio of psychoactive drugs/medicines in whole blood-plasma-saliva and correlation to symptoms of impairment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2013.