MedDrive's Responsiveness to Alcohol (OH-MedDrive)

University of Lausanne (UNIL)

Status: Completed

Conditions: Impaired Driving

Treatments: Other: Ethanol; Other: Cranberry juice

Study type: Interventional

Funder types: Other

Identifiers

NCT01781273

CE-12-277

Details and patient eligibility

About

This four-way, dose-response, crossover, double blind, placebo-controlled, randomised validation study investigates the responsiveness of MedDrive, a computed battery of neuropsychological tasks, to different doses of alcohol.

The following hypothesis are tested:

1. Measures from MedDrive are influenced by alcohol in a dose dependent way.
2. Effects of alcohol on driving performances are correlated to measures from MedDrive in a dose dependent way.
3. Within a group of healthy young drivers, MedDrive shows consistent results over repeated measures (ICC≥0.7).
4. MedDrive models effects of alcohol on driving performances better than does the UFOV or the trial making task.

Full description

Background: There is an increasing need for physicians to advice patients on their fitness to drive. Current guidelines underline the limitations of existing instruments and the poor adaptability of batteries of neuropsychological tests assessing fitness to drive in both experimental and primary care settings. The investigators therefore developed MedDrive, a free, reliable, computer based measuring instrument capable of detecting effects of age and drugs on cognitive functions considered as essential for driving.

Objectives: This study aims to test MedDrive responsiveness to different blood alcohol concentrations (BAC) and validate these measures against performances on a driving simulator. It also aims to measure MedDrive's reliability following repeated measures during the training phase, to compare MedDrive's performances in measuring effects of different BAC against the UFOV, and to model MedDrives measures to predict behaviour on the simulator. Finally, this study also includes a nested experimental study measuring effects of alcohol on attention.

Methods: Using Widmark's formula, 16 healthy young drivers are given cranberry juice with different doses of ethanol to bring their BAC to 0 g/L, 0.5 g/L, 0.65 g/L, and 0.8 g/L. They are blinded to the presence of ethanol by inhaling vapors of ethanol just before drinking. BAC is maintained during the entire experiment by using a breathalyser and administrating drinks throughout the experiment. Three scenarios are planned on a driving simulator (StSoftware PvW-2010), a road tracking task, a car following task, and a car following task including dual tasking using peripheral vision.

Enrollment: 21 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 20 to 40 years
• Obtained drivers license at least 24 months before
• Fit to drive
• Consumed at least once six units of a beverage with alcohol at a single occasion during the previous six months

Exclusion criteria

• Under the influence of a medicinal drug affecting their driving performance
• Suffer from a psychiatric condition affecting driving performances
• Suffer from simulator sickness
• Presenting criteria (ICD-10) of alcohol dependence.
• Pregnant or breastfeeding
• Intolerant to alcohol defined by having either headaches or digestive disorders for quantities of alcohol that do not seem to bother other people.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 4 patient groups, including a placebo group

Cranberry juice alone

Placebo Comparator group

Description:

500 mL of cranberry juice

Treatment:

Other: Cranberry juice

BAC 0.5 g/L

Experimental group

Description:

Cranberry juice with ethanol to rise BAC to 0.5 g/L

Treatment:

Other: Ethanol

Other: Cranberry juice

BAC 0.65 g/L

Experimental group

Description:

Cranberry juice with ethanol to rise BAC to 0.65 g/L

Treatment:

Other: Ethanol

Other: Cranberry juice

BAC 0.8 g/L

Experimental group

Description:

Cranberry juice with ethanol to rise BAC to 0.8 g/L

Treatment:

Other: Ethanol

Other: Cranberry juice