Driving Under the InfluenceNCT00648206
Testing Alcohol Only Samples for Drugs and Drugs Only Samples for Alcohol
An observational study of Driving Under the Influence, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
This study intends to supply information about the prevalence of psychoactive drugs and alcohol in suspected DUI samples which are suspected of only one of these rather than both drugs and alcohol. 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
- 250 participants
- Where
- 1 siteFinland
- Study dates
- Sep 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: Retrospective Study of Unrequested Analytical Data in DUID-cases From a 2 Week Period
This study intends to supply information about the prevalence of psychoactive drugs and alcohol in suspected DUI samples which are suspected of only one of these rather than both drugs and alcohol.
Police samples for suspected DUI samples that have been sent for alcohol analysis or drug analysis only will be screened for drugs and alcohol respectively.
Read the detailed description
There are 3 different possibilities for forensic analysis of suspected driving under the influence samples. Testing for alcohol or drugs only or testing for both alcohol and drugs.
Often if the primary suspicion of the apprehending police officer is of driving under the influence of drugs or alcohol then only laboratory analysis concerning that primary suspicion is requested.
The study aims to provide information about those 'missed cases' where only analysis for drugs or alcohol is carried out. Traffic police samples from a 2 week period are to be screened for both drugs and alcohol, even if the primary suspicion is only one of these.
The study is part of the EU-project DRUID. Altogether 13 European countries are participating in DRUID.
- Conditions
- Driving Under the Influence
- Keywords
- driving under the influence, psychoactive substances, blood samples, 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 driving under the influence of psychoactive drugs or alcohol | |
| 2 | drivers stopped in police traffic controls and breathalysed positive for alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of both alcohol and drugs in suspected DUI cases
Measured: 2 weeks
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 startSep 2008
- Primary completionSep 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 crossover
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- 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
- NCT00648206
- Sponsor's protocol ID
- KTL 419-9
- 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
- Retrospective Study of Unrequested Analytical Data in DUID-cases From a 2 Week Period
- ClinicalTrials.gov ID
- NCT00648206
- Acronym / sponsor ID
- KTL 419-9
- Conditions
- Driving Under the Influence
- Keywords
- driving under the influence, psychoactive substances, blood samples, Prevalence of psychoactive substances in road traffic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Ministry of Internal Affairs, Finland, European Commission
- Study start
- Sep 2008
- Primary completion
- Sep 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.
This study intends to supply information about the prevalence of psychoactive drugs and alcohol in suspected DUI samples which are suspected of only one of these rather than both drugs and alcohol.
Police samples for suspected DUI samples that have been sent for alcohol analysis or drug analysis only will be screened for drugs and alcohol respectively.
Detailed description
There are 3 different possibilities for forensic analysis of suspected driving under the influence samples. Testing for alcohol or drugs only or testing for both alcohol and drugs.
Often if the primary suspicion of the apprehending police officer is of driving under the influence of drugs or alcohol then only laboratory analysis concerning that primary suspicion is requested.
The study aims to provide information about those 'missed cases' where only analysis for drugs or alcohol is carried out. Traffic police samples from a 2 week period are to be screened for both drugs and alcohol, even if the primary suspicion is only one of these.
The study is part of the EU-project DRUID. Altogether 13 European countries are participating in DRUID.
Study design
- Observational model
- Case crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –drivers of motorised vehicles suspected of driving under the influence of psychoactive drugs or alcohol |
| 2 | – | –drivers stopped in police traffic controls and breathalysed positive for alcohol |
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
assessment of both alcohol and drugs in suspected DUI cases
Time frame: 2 weeks
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?
assessment of both alcohol and drugs in suspected DUI cases (time frame: 2 weeks). 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.