MedDrive's Responsiveness to Alcohol

NCT ID: NCT01781273

Last Updated: 2013-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-04-30

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.

Conditions

Impaired Driving

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Cranberry juice alone

500 mL of cranberry juice

Group Type: PLACEBO_COMPARATOR

Cranberry juice

Intervention Type: OTHER

100 mL cranberry juice is provided in a 250 ml container.

BAC 0.5 g/L

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

Group Type: EXPERIMENTAL

Ethanol

Intervention Type: OTHER

During a 45 min period, investigators will ask participants to drink 500ml of cranberry juice, 100 ml at a time each 5 minutes. Depending of the allocation, these drinks will contain more or less alcohol. Pure ethanol will be used mixed with the beverage. The amount of alcohol to dilute in the drink will be calculated using Widmarks formula. Participants will move to the simulator room 20 minutes after having finished drinking the first 500 ml. To maintain the BAC level, investigators will use a breathalyser and provide 100 ml cranberry juice every 20 minutes with the amount of necessary alcohol. The person administrating drinks will hand over the drinks and make sure the participants breaths in before taking a sip, thereby inhaling alcohol vapour from the lid and keeping them blinded to the content.

Cranberry juice

Intervention Type: OTHER

100 mL cranberry juice is provided in a 250 ml container.

BAC 0.65 g/L

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

Group Type: EXPERIMENTAL

Ethanol

Intervention Type: OTHER

During a 45 min period, investigators will ask participants to drink 500ml of cranberry juice, 100 ml at a time each 5 minutes. Depending of the allocation, these drinks will contain more or less alcohol. Pure ethanol will be used mixed with the beverage. The amount of alcohol to dilute in the drink will be calculated using Widmarks formula. Participants will move to the simulator room 20 minutes after having finished drinking the first 500 ml. To maintain the BAC level, investigators will use a breathalyser and provide 100 ml cranberry juice every 20 minutes with the amount of necessary alcohol. The person administrating drinks will hand over the drinks and make sure the participants breaths in before taking a sip, thereby inhaling alcohol vapour from the lid and keeping them blinded to the content.

Cranberry juice

Intervention Type: OTHER

100 mL cranberry juice is provided in a 250 ml container.

BAC 0.8 g/L

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

Group Type: EXPERIMENTAL

Ethanol

Intervention Type: OTHER

During a 45 min period, investigators will ask participants to drink 500ml of cranberry juice, 100 ml at a time each 5 minutes. Depending of the allocation, these drinks will contain more or less alcohol. Pure ethanol will be used mixed with the beverage. The amount of alcohol to dilute in the drink will be calculated using Widmarks formula. Participants will move to the simulator room 20 minutes after having finished drinking the first 500 ml. To maintain the BAC level, investigators will use a breathalyser and provide 100 ml cranberry juice every 20 minutes with the amount of necessary alcohol. The person administrating drinks will hand over the drinks and make sure the participants breaths in before taking a sip, thereby inhaling alcohol vapour from the lid and keeping them blinded to the content.

Cranberry juice

Intervention Type: OTHER

100 mL cranberry juice is provided in a 250 ml container.

Interventions

Ethanol

During a 45 min period, investigators will ask participants to drink 500ml of cranberry juice, 100 ml at a time each 5 minutes. Depending of the allocation, these drinks will contain more or less alcohol. Pure ethanol will be used mixed with the beverage. The amount of alcohol to dilute in the drink will be calculated using Widmarks formula. Participants will move to the simulator room 20 minutes after having finished drinking the first 500 ml. To maintain the BAC level, investigators will use a breathalyser and provide 100 ml cranberry juice every 20 minutes with the amount of necessary alcohol. The person administrating drinks will hand over the drinks and make sure the participants breaths in before taking a sip, thereby inhaling alcohol vapour from the lid and keeping them blinded to the content.

Intervention Type: OTHER

Cranberry juice

100 mL cranberry juice is provided in a 250 ml container.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

University of Lausanne

OTHER

Sponsor Role: lead

Responsible Party

Bernard Favrat, MD

Head of Unit of Traffic Medicine and Psychology, Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernard Favrat, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV, University of Lausanne

Patrice Mangin, MD, PhD

Role: STUDY_DIRECTOR

CHUV, University of Lausanne

Locations

Institute of Legal Medicine, University of Geneva

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

Other Identifiers

CE-12-277

Identifier Type: -

Identifier Source: org_study_id