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Development of a Valid Test Battery for Assessing Driving Ability When Influenced by Drugs.

NCT ID: NCT00967421

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-11-30

Brief Summary

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The purpose of the validation study is to develop a valid test battery for assessing driving ability in a driving simulator when influenced by drugs. Ethanol has known, well-documented and well-characterized effects on driving behaviour and accident risk, and will be used to assess the simulator test scenarios' sensitivity to drug effects. Once the test scenarios have been refined and their ability to predict driving accident risk have been validated, we plan to use the simulator to assess driving ability under the influence of different drugs suspected to produce driving impairment.

Detailed Description

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Conditions

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Automobile Driving

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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BAC 0.5

BAC level 0.5 g/dL (drink + placebo pill)

Group Type EXPERIMENTAL

ethanol

Intervention Type DRUG

BAC level 0.5 g/dL (drink + placebo pill). Drink with 2,4 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill.

BAC 1.0

BAC level 1.0 g/dL (drink + placebo pill)

Group Type EXPERIMENTAL

Ethanol

Intervention Type DRUG

BAC level 1.0 g/dL (drink + placebo pill). Drink with 3,6 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill.

placebo

BAC level 0,0 g/dL (placebo drink+ placebo pill)

Group Type PLACEBO_COMPARATOR

Placebo drink

Intervention Type OTHER

Placebo drink containing no alcohol + placebo pill

Interventions

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ethanol

BAC level 0.5 g/dL (drink + placebo pill). Drink with 2,4 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill.

Intervention Type DRUG

Ethanol

BAC level 1.0 g/dL (drink + placebo pill). Drink with 3,6 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill.

Intervention Type DRUG

Placebo drink

Placebo drink containing no alcohol + placebo pill

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy, caucasian males aged 25-50 years in possession of a valid driver's license for the last 5 years.
* Recreational alcohol drinkers without alcohol dependence or abuse, no traffic-related convictions or alcohol-influenced behavioural disturbances.
* 1 or 0 points on the modified Apfel scale for predicting post-operative nausea/vomiting (non-smoker, previously experienced nausea/vomiting post-operatively, previously experienced motion sickness)

Exclusion Criteria

* Females (risk of teratogenicity)
* Non-caucasian ethnicity (possibility of deviant ethanol metabolism)
* Previous strong reactions such as nausea, fainting etc. during blood sampling
* Previous abnormal reactions to ethanol
* Previous convictions related to drug intoxication
* Previous excessive drug use
* Regular use of prescription drugs
* Two points or more according to the modified Apfel criteria
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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SINTEF Health Research

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Slørdal, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Gunnar D Jenssen

Role: PRINCIPAL_INVESTIGATOR

SINTEF Health Research

Locations

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SINTEF Health and Research

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Helland A, Jenssen GD, Lervag LE, Westin AA, Moen T, Sakshaug K, Lydersen S, Morland J, Slordal L. Comparison of driving simulator performance with real driving after alcohol intake: a randomised, single blind, placebo-controlled, cross-over trial. Accid Anal Prev. 2013 Apr;53:9-16. doi: 10.1016/j.aap.2012.12.042. Epub 2013 Jan 28.

Reference Type RESULT
PMID: 23357031 (View on PubMed)

Helland A, Jenssen GD, Lervag LE, Moen T, Engen T, Lydersen S, Morland J, Slordal L. Evaluation of measures of impairment in real and simulated driving: Results from a randomized, placebo-controlled study. Traffic Inj Prev. 2016;17(3):245-50. doi: 10.1080/15389588.2015.1065975. Epub 2015 Jul 6.

Reference Type RESULT
PMID: 26147898 (View on PubMed)

Other Identifiers

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ES437291 VALIDAD

Identifier Type: -

Identifier Source: org_study_id