MedDrive's Responsiveness to Alcohol (OH-MedDrive)

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

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.

Study Overview

• Status: Completed
• Conditions: Impaired Driving
• Intervention / Treatment: Other: Cranberry juice; Other: Ethanol

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva
    • Geneva 4, Geneva, Switzerland, 1211
      • Institute of Legal Medicine, University of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Cranberry juice alone; 500 mL of cranberry juice	Other: Cranberry juice; 100 mL cranberry juice is provided in a 250 ml container.
Experimental: BAC 0.5 g/L; Cranberry juice with ethanol to rise BAC to 0.5 g/L	Other: Cranberry juice; 100 mL cranberry juice is provided in a 250 ml container.; Other: 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.
Experimental: BAC 0.65 g/L; Cranberry juice with ethanol to rise BAC to 0.65 g/L	Other: Cranberry juice; 100 mL cranberry juice is provided in a 250 ml container.; Other: 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.
Experimental: BAC 0.8 g/L; Cranberry juice with ethanol to rise BAC to 0.8 g/L	Other: Cranberry juice; 100 mL cranberry juice is provided in a 250 ml container.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
central visual processing time	Corresponds to the duration of exposure in ms for a 37.5% threshold for correct guesses adjusted for chance for central vision in the Visual Recognition Task (Task 1) in MedDrive.	1 hour post-intervention
peripheral visual processing time	Corresponds to the duration of exposure in ms for a 43.8% threshold for correct guesses adjusted for chance for peripheral vision in the Visual Recognition Task (Task 1) in MedDrive.	1 hour post-intervention
dual task processing time	Corresponds to the duration of exposure in ms for a 48.7% threshold for correct guesses adjusted for chance for simultaneous central and peripheral vision (dual tasking) in the Visual Recognition Task (Task 1) in MedDrive.	1 hour post-intervention
neutral response time	Corresponds to the average response time in ms adjusted for learning effect for participants to respond to a peripheral stimuli during the Central Cue Attention Task (Task 2) in MedDrive.	1 hour post-intervention
conditioned alerting gain	Corresponds to the average gain in response time (ms) over the neutral condition after participants are warned of the imminent exposure to a peripheral stimuli during the Central Cue Attention Task (Task 2) in MedDrive.	1 hour post-intervention
orientation gain	Corresponds to the average gain in response time (ms) over the neutral condition after participants are shown where the peripheral stimuli is to show up during the Central Cue Attention Task (Task 2) in MedDrive.	1 hour post-intervention
attention shift response time	Corresponds to the average response time in ms to detect the orientation of a given moving target during the Movement Detection Task (Task 3) in MedDrive.	1 hour post-intervention
distance to first cue	Corresponds to the geometrical mean of distances in mm between the true location of the first cue and its indicated location during the Memory Decay of Spatial Resolution Task (Task 4) in MedDrive.	1 hour post-intervention
distance to last cue	Corresponds to the geometrical mean of distances in mm between the true location of the last cue and its indicated location during the Memory Decay of Spatial Resolution Task (Task 4) in MedDrive.	1 hour post-intervention
spatial resolution decay	Corresponds to the loss in precision for each extra cue shown during the Memory Decay of Spatial Resolution Task (Task 4) in MedDrive (ln(mm)/cue).	1 hour post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Useful Field of View	The UFOV is a neuropsychological task which provides four outputs: visual processing, divided attention, selective attention, and overall risk	1 hour post-intervention
Trial Making Task	The duration of tasks TMT-A and TMT-B are provided in seconds	1 hour post-intervention
StSoftware driving simulator	Standard lateral deviation from the center of the road during the road tracking task, and gain and delay during the car following tasks	1 hour post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	New symptoms, accidents, hospitalisation are recorded one week after each visit.	1 week after intervention

Collaborators and Investigators

• Sponsor: University of Lausanne
• Collaborators: University Hospital, Geneva; University of Lausanne Hospitals
• Investigators: Principal Investigator: Bernard Favrat, MD, CHUV, University of Lausanne; Study Director: Patrice Mangin, MD, PhD, CHUV, University of Lausanne

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 28, 2013
• First Submitted That Met QC Criteria: January 29, 2013
• First Posted (Estimate): January 31, 2013

Study Record Updates

• Last Update Posted (Estimate): April 23, 2013
• Last Update Submitted That Met QC Criteria: April 20, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: impaired driving
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: CE-12-277