Prevalence of Psychoactive Substances in Road TrafficNCT00570518
Alcohol and Other Psychoactive Substances in Road Traffic - a Case-control Study
An observational study of Prevalence of Psychoactive Substances in Road Traffic and Psychoactive Substances in Accident Involved Drivers, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
The main purpose of the study is to determine the accident risk when driving under the influence of psychoactive substances, including alcohol (DUI). Other aims are to find out the prevalence of psychoactive substances in road traffic and to obtain information on the role of these substances in road traffic accident… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevalence of Psychoactive Substances in Road Traffic, Psychoactive Substances in Accident Involved Drivers, Relative Risk Estimation of Accident Involvement for Impaired Drivers
- How many people
- 4,500 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2007to 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 and bicycles in general road traffic or drivers of motorised vehicles and bicycles, injured or killed in road traffic accidents
Who may be able to join
- 18 years or older
- driver of a motorised vehicle or bicycle
- is willing to participate to the study (not applicable to the diseased drivers; information obtained from a register database)
Who cannot join
- 17 or younger
- not the driver of a motorised vehicle or bicycle
- does not want to participate (not applicable to the diseased drivers; information obtained from a register database)
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
National Public Health Institute
Helsinki, 00300
Pirjo Lillsunde, Dr, +358947448342, pirjo.lillsunde@ktl.fi
Charlotta Engblom, M.Sc.(Tech.), +358947448546, charlotta.engblom@ktl.fi
About this study
Official title: DRUID Work Package 2 - Epidemiology
The main purpose of the study is to determine the accident risk when driving under the influence of psychoactive substances, including alcohol (DUI). Other aims are to find out the prevalence of psychoactive substances in road traffic and to obtain information on the role of these substances in road traffic accident causations.
For the purposes of the study, drivers of motorised vehicles are randomly stopped and interviewed and breath alcohol is recorded. Also, an oral fluid sample is taken and psychoactive substances are investigated in the laboratory. For cases, drivers injured in traffic accidents are asked to participate to the study. A whole blood sample and, if possible, an oral fluid sample is taken and psychoactive substances are determined in the laboratory. Also, people diseased in road traffic accident are included in the study. The information required for these subjects are taken from a register database.
The study is part of an EU-project DRUID. Altogether 13 European countries take part to the study.
- Conditions
- Prevalence of Psychoactive Substances in Road Traffic, Psychoactive Substances in Accident Involved Drivers, Relative Risk Estimation of Accident Involvement for Impaired Drivers
- Keywords
- driving under the influence, psychoactive substances, roadside surveys, hospital surveys, accident involvement risk estimation
- 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 | randomly stopped drivers of motorised vehicles and bicycles | |
| 2 | drivers of motorised vehicles and bicycles injured or killed in road traffic accidents |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative risk estimation of accident involvement for drivers impaired by psychoactive substances
Measured: three years
Secondary outcomes (2)
prevalence of psychoactive substances in the general driving population
Measured: three years
prevalence of psychoactive substances among accident involved drivers
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 startSep 2007
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevalence of Psychoactive Substances in Road TrafficStudies 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
- 4,500 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
- NCT00570518
- Sponsor's protocol ID
- KTL 403-2
- Other IDs
- 404-3, 405-9, 406-5
- Status last verified
- Sep 2011
- First submitted
- 10 Dec 2007
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRUID Work Package 2 - Epidemiology
- ClinicalTrials.gov ID
- NCT00570518
- Acronym / sponsor ID
- KTL 403-2
- Conditions
- Prevalence of Psychoactive Substances in Road Traffic, Psychoactive Substances in Accident Involved Drivers, Relative Risk Estimation of Accident Involvement for Impaired Drivers
- Keywords
- driving under the influence, psychoactive substances, roadside surveys, hospital surveys, accident involvement risk estimation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Hospital District of Helsinki and Uusimaa, European Commission
- Study start
- Sep 2007
- Study completion
- Oct 2011 (estimated)
- 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.
The main purpose of the study is to determine the accident risk when driving under the influence of psychoactive substances, including alcohol (DUI). Other aims are to find out the prevalence of psychoactive substances in road traffic and to obtain information on the role of these substances in road traffic accident causations.
For the purposes of the study, drivers of motorised vehicles are randomly stopped and interviewed and breath alcohol is recorded. Also, an oral fluid sample is taken and psychoactive substances are investigated in the laboratory. For cases, drivers injured in traffic accidents are asked to participate to the study. A whole blood sample and, if possible, an oral fluid sample is taken and psychoactive substances are determined in the laboratory. Also, people diseased in road traffic accident are included in the study. The information required for these subjects are taken from a register database.
The study is part of an EU-project DRUID. Altogether 13 European countries take part to the study.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –randomly stopped drivers of motorised vehicles and bicycles |
| 2 | – | –drivers of motorised vehicles and bicycles injured or killed in road traffic accidents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- drivers of motorised vehicles and bicycles in general road traffic or drivers of motorised vehicles and bicycles, injured or killed in road traffic accidents
Key inclusion criteria (3 listed)
- 18 years or older
- driver of a motorised vehicle or bicycle
- is willing to participate to the study (not applicable to the diseased drivers; information obtained from a register database)
Key exclusion criteria (3 listed)
- 17 or younger
- not the driver of a motorised vehicle or bicycle
- does not want to participate (not applicable to the diseased drivers; information obtained from a register database)
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
relative risk estimation of accident involvement for drivers impaired by psychoactive substances
Time frame: three years
2 secondary outcomes
prevalence of psychoactive substances in the general driving population
Time frame: three years
prevalence of psychoactive substances among accident involved drivers
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
- The official homepage of the EU-projectLink 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 Prevalence of Psychoactive Substances in Road Traffic and Psychoactive Substances in Accident Involved Drivers, 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 3 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: status not confirmed, as of the sponsor's last update on 3 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pirjo Lillsunde, Dr (+358947448342, pirjo.lillsunde@ktl.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative risk estimation of accident involvement for drivers impaired by psychoactive substances (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 3 Oct 2011.