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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1
SINTEF Health and Research
Trondheim, Norway, 7465