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

Automobile Driving Clinical Trial

— VALIDAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967421
• Other study ID #: ES437291 VALIDAD
• Status: Completed
• Phase: N/A
• First received: August 26, 2009
• Last updated: September 28, 2017
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: September 2017
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Automobile Driving

Intervention

Drug:
• 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.
• 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.

Other:
• Placebo drink
Placebo drink containing no alcohol + placebo pill

Locations

Country	Name	City	State
Norway	SINTEF Health and Research	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian Institute of Public Health, Norwegian University of Science and Technology, SINTEF Health Research

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Helland A, Jenssen GD, Lervåg LE, Moen T, Engen T, Lydersen S, Mørland J, Slørdal 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 — View Citation

Helland A, Jenssen GD, Lervåg LE, Westin AA, Moen T, Sakshaug K, Lydersen S, Mørland J, Slørdal L. Comparison of driving simulator performance with real driving after alcohol intake: a randomised, single blind, placebo-controlled, cross-over trial. Accid — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard deviation of lateral position on road (SDLP)		Instantly (while the subject is inebriated)