Clinical trial NCT00967421: Development of a Valid Test Battery for Assessing Driving Ability When Influenced by Drugs.
Official title: Development of a Valid Test Battery for Assessing Driving Ability When Influenced by Drugs.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Automobile Driving
Keywords: Driving
DUI
Driving simulation
Drugs
Ethanol
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: SINTEF Health Research
name: Norwegian University of Science and Technology
name: Norwegian Institute of Public Health
First posted: 2009-08-27
Enrollment: 20
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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-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.


Eligibility criteria: 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

Primary outcomes:
measure: Standard deviation of lateral position on road (SDLP)
timeFrame: Instantly (while the subject is inebriated)
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: SINTEF Health and Research
Study officials:
affiliation: Norwegian University of Science and Technology
name: Lars Slørdal, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SINTEF Health Research
name: Gunnar D Jenssen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.