- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00570518
Alcohol and Other Psychoactive Substances in Road Traffic - a Case-control Study
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.
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
-
Helsinki, Finland, 00300
- Rekruttering
- National Public Health Institute
-
Kontakt:
- Pirjo Lillsunde, Dr
- Telefonnummer: +358947448342
- E-mail: pirjo.lillsunde@ktl.fi
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Kontakt:
- Charlotta Engblom, M.Sc.(Tech.)
- Telefonnummer: +358947448546
- E-mail: charlotta.engblom@ktl.fi
-
Ledende efterforsker:
- Pirjo Lillsunde, Dr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
1
randomly stopped drivers of motorised vehicles and bicycles
|
|
2
drivers of motorised vehicles and bicycles injured or killed in road traffic accidents
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
relative risk estimation of accident involvement for drivers impaired by psychoactive substances
Tidsramme: three years
|
three years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
forekomsten af psykoaktive stoffer i den almindelige bilistpopulation
Tidsramme: 3 år
|
3 år
|
|
prevalence of psychoactive substances among accident involved drivers
Tidsramme: three years
|
three years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Pirjo Lillsunde, Dr, National Public Health Institute
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- KTL 403-2
- 404-3
- 405-9
- 406-5
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