Drug-impaired DrivingNCT00571207
Oral Fluid Screening Devices
An observational study of Drug-impaired Driving, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
This research includes the evaluation of a checklist and on-site screening devices to pre-select drivers suspected of being drug-impaired. The reliability of a limited number of promising on-site screening devices will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug-impaired Driving
- What is being tested?
- On-site oral fluid screening devices and Checklist: drug recognition expert
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2008to Oct 2010
- 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 suspected of driving under the influence of drugs. Also drivers who are not suspected of driving under the influence.
Who may be able to join
- Drivers of motorised vehicles
- 18 years or older
- Willing to participate
Who cannot join
- Younger than 18
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scientific Evaluation of Oral Fluid Screening Devices and Preceding Selection Procedures
This research includes the evaluation of a checklist and on-site screening devices to pre-select drivers suspected of being drug-impaired. The reliability of a limited number of promising on-site screening devices will be investigated. The devices tested will have to be promising regarding both reliability and practicality. In addition to the scientific evaluation of the checklist and the oral fluid screening devices, the time consumption of the selection procedure as a whole (checklist + oral fluid screening) will be evaluated.
Outcome of the study will be recommendations for the roadside selection procedure of drivers suspected of drug-related impairment. The recommendations will concentrate on the reliability of the selection procedure.
The study is part of an EU project DRUID. Two other countries in Europe take part to this study along with Finland.
- Conditions
- Drug-impaired Driving
- Being tested
- On-site oral fluid screening devices, Checklist: drug recognition expert
- Keywords
- driving under the influence of drugs, on-site oral fluid screening devices, checklist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-site oral fluid screening devicesDevice
Comparison of screening device results to oral and/or blood sample results
Checklist: drug recognition expertBehavioural
Correlation of drug recognition expert observations to findings for drugs in non-suspected/suspected cases
| Study group | Role | What they receive |
|---|---|---|
| I | Drivers suspected of driving under the influence of drugs Receives: Device: On-site oral fluid screening devices; Behavioral: Checklist: drug recognition expert | |
| II | Drivers not suspected of driving under the influence of drugs Receives: Device: On-site oral fluid screening devices; Behavioral: Checklist: drug recognition expert |
What is being measured
The primary outcome is the main question the study is designed to answer.
scientific evaluation of the on-site oral fluid screening devices
Measured: three years
Secondary outcomes (2)
evaluation on the police checklist
Measured: three years
the time consumption of the selection procedure as a whole (checklist + oral fluid screening)
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 posted11 Dec 2007 (estimated)
- Study startApr 2008
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-impaired DrivingStudies 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
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Hospital District of Helsinki and Uusimaa, European Commission
- Responsible party
- Sponsor
- Investigators
- Pirjo Lillsunde, Dr, Principal investigator, National Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571207
- Sponsor's protocol ID
- KTL 402-1
- Status last verified
- Aug 2011
- First submitted
- 10 Dec 2007
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Evaluation of Oral Fluid Screening Devices and Preceding Selection Procedures
- ClinicalTrials.gov ID
- NCT00571207
- Acronym / sponsor ID
- KTL 402-1
- Conditions
- Drug-impaired Driving
- Keywords
- driving under the influence of drugs, on-site oral fluid screening devices, checklist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Hospital District of Helsinki and Uusimaa, European Commission
- Study start
- Apr 2008
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Dec 2007 (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.
This research includes the evaluation of a checklist and on-site screening devices to pre-select drivers suspected of being drug-impaired. The reliability of a limited number of promising on-site screening devices will be investigated. The devices tested will have to be promising regarding both reliability and practicality. In addition to the scientific evaluation of the checklist and the oral fluid screening devices, the time consumption of the selection procedure as a whole (checklist + oral fluid screening) will be evaluated.
Outcome of the study will be recommendations for the roadside selection procedure of drivers suspected of drug-related impairment. The recommendations will concentrate on the reliability of the selection procedure.
The study is part of an EU project DRUID. Two other countries in Europe take part to this study along with Finland.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | – | Device: On-site oral fluid screening devices, Behavioral: Checklist: drug recognition expertDrivers suspected of driving under the influence of drugs |
| II | – | Device: On-site oral fluid screening devices, Behavioral: Checklist: drug recognition expertDrivers not suspected of driving under the influence of drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Drivers suspected of driving under the influence of drugs. Also drivers who are not suspected of driving under the influence.
Key inclusion criteria (3 listed)
- Drivers of motorised vehicles
- 18 years or older
- Willing to participate
Key exclusion criteria (2 listed)
- Younger than 18
- Not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-site oral fluid screening devicesComparison of screening device results to oral and/or blood sample results | Device | I, II |
| Checklist: drug recognition expertCorrelation of drug recognition expert observations to findings for drugs in non-suspected/suspected cases | Behavioural | I, II |
Primary outcome
scientific evaluation of the on-site oral fluid screening devices
Time frame: three years
2 secondary outcomes
evaluation on the police checklist
Time frame: three years
the time consumption of the selection procedure as a whole (checklist + oral fluid screening)
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 2 Sep 2011.
- Related InfoLink provided by the sponsor.
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
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 Drug-impaired Driving, 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 3 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 2 Sep 2011. 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?
scientific evaluation of the on-site oral fluid screening devices (time frame: three years). 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 2 Sep 2011.