Status:

COMPLETED

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

Lead Sponsor:

St. Olavs Hospital

Collaborating Sponsors:

SINTEF Health Research

Norwegian University of Science and Technology

Conditions:

Automobile Driving

Eligibility:

MALE

25-50 years

Phase:

NA

Brief Summary

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-charac...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2010

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00967421

Start Date

September 1 2009

End Date

November 1 2010

Last Update

October 2 2017

Active Locations (1)

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SINTEF Health and Research

Trondheim, Norway, 7465