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

Study Overview
=================
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.

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

Conditions
-----------------
Automobile Driving

Intervention / Treatment
-----------------
* Drug: ethanol
* Drug: Ethanol
* Other: Placebo drink


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAC 0.5<br>BAC level 0.5 g/dL (drink + placebo pill) | Drug: ethanol<br>* 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.<br>|
| Experimental: BAC 1.0<br>BAC level 1.0 g/dL (drink + placebo pill) | Drug: Ethanol<br>* 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.<br>|
| Placebo Comparator: placebo<br>BAC level 0,0 g/dL (placebo drink+ placebo pill) | Other: Placebo drink<br>* Placebo drink containing no alcohol + placebo pill<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard deviation of lateral position on road (SDLP) |  | Instantly (while the subject is inebriated) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Driving, DUI, Driving simulation, Drugs, Ethanol