Clinical trial NCT01781273: MedDrive's Responsiveness to Alcohol
Official title: MedDrive's Responsiveness to Different Blood Alcohol Concentrations and Concurrent Validity Against Performances on a Driving Simulator; a Phase I, Randomised, Double Blind, Placebo, Dose Response Validation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Driving
Keywords: impaired driving
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
name: University Hospital, Geneva
First posted: 2013-01-31
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: central visual processing time
timeFrame: 1 hour post-intervention
measure: peripheral visual processing time
timeFrame: 1 hour post-intervention
measure: dual task processing time
timeFrame: 1 hour post-intervention
measure: neutral response time
timeFrame: 1 hour post-intervention
measure: conditioned alerting gain
timeFrame: 1 hour post-intervention
measure: orientation gain
timeFrame: 1 hour post-intervention
measure: attention shift response time
timeFrame: 1 hour post-intervention
measure: distance to first cue
timeFrame: 1 hour post-intervention
measure: distance to last cue
timeFrame: 1 hour post-intervention
measure: spatial resolution decay
timeFrame: 1 hour post-intervention
Secondary outcomes:
measure: Useful Field of View
timeFrame: 1 hour post-intervention
measure: Trial Making Task
timeFrame: 1 hour post-intervention
measure: StSoftware driving simulator
timeFrame: 1 hour post-intervention
Other outcomes:
measure: Adverse events
timeFrame: 1 week after intervention
Locations:
city: Geneva 4
country: Switzerland
facility: Institute of Legal Medicine, University of Geneva
state: Geneva
Study officials:
affiliation: CHUV, University of Lausanne
name: Bernard Favrat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUV, University of Lausanne
name: Patrice Mangin, MD, PhD
role: STUDY_DIRECTOR
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