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

Not Applicable

Completed

• Conditions: Automobile Driving
• Interventions: Other: Placebo drink; Drug: Ethanol

• Registration Number: NCT00967421
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Study Start: 2009-09
• Primary Completion: 2009-11
• Study Completion: 2010-11
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	Placebo drink	BAC level 0,0 g/dL (placebo drink+ placebo pill)
BAC 0.5	Ethanol	BAC level 0.5 g/dL (drink + placebo pill)
BAC 1.0	Ethanol	BAC level 1.0 g/dL (drink + placebo pill)

Primary Outcome Measures

Name	Time	Method
Standard deviation of lateral position on road (SDLP)	Instantly (while the subject is inebriated)

Trial Locations

Locations (1)

SINTEF Health and Research; 🇳🇴 Trondheim, Norway