Testing Alcohol Only Samples for Drugs and Drugs Only Sam... | NCT00648206

Studies
Testing Alcohol Only Samples for Drugs and Drugs Only Samples for Alcohol

NCT00648206

Sponsor

Finnish Institute for Health and Welfare

Status

Completed

Last Update Posted

Nov 4, 2013Estimated

Enrollment

250Actual

Phase

Not provided

Conditions

Driving Under the Influence

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Oct 2011Actual

First Submitted Date

Mar 27, 2008

First Submission Date that Met QC Criteria

Mar 31, 2008

First Posted Date

Apr 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2013

Last Update Posted Date

Nov 4, 2013Estimated

Name	Class
Ministry of Internal Affairs, Finland	UNKNOWN
European Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
assessment of both alcohol and drugs in suspected DUI cases		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
prevalence of psychoactive substances in the general driving population		three years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
driver of a motorised vehicle

Exclusion Criteria:

17 years or younger
not the driver of a motorised vehicle

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

drivers of motorised vehicles in general road traffic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pirjo Lillsunde, Dr	National Public Health Institute, Helsinki, Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Public Health Institute		Helsinki			Finland

Label	URL
Official home page of the EU-project	View source

Condition Browse Module

MeSH Terms

ID	Term
D000066448	Driving Under the Influence

Ancestor Terms

ID	Term
D000066479	Criminal Behavior
D001519	Behavior
D003617	Dangerous Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Whole blood samples are collected for the study. However no DNA detection is done at any point in the study. The laboratory where the samples are analysed does not analyse DNA. DNA is not relevant for this study