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

St. Olavs Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Automobile Driving

Interventions

ethanolDRUG

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.

EthanolDRUG

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.

Placebo drinkOTHER

Placebo drink containing no alcohol + placebo pill

Eligibility

Sex: MALEMin age: 25 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SINTEF Health and Research

Trondheim, Norway

Outcomes

Primary Outcomes

Standard deviation of lateral position on road (SDLP)

Time frame: Instantly (while the subject is inebriated)

Data from ClinicalTrials.gov

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