MedDrive's Responsiveness to Alcohol (OH-MedDrive)

This study has been completed.
Sponsor:
Collaborators:
University of Lausanne Hospitals
University Hospital, Geneva
Information provided by (Responsible Party):
Bernard Favrat, MD, University of Lausanne
ClinicalTrials.gov Identifier:
NCT01781273
First received: January 28, 2013
Last updated: April 20, 2013
Last verified: April 2013
  Purpose

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.

Condition Intervention
Impaired Driving
Other: Ethanol
Other: Cranberry juice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
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

Further study details as provided by University of Lausanne:

Primary Outcome Measures:
  • central visual processing time [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    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.

  • peripheral visual processing time [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    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.

  • dual task processing time [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    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.

  • neutral response time [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    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.

  • conditioned alerting gain [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    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.

  • orientation gain [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    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.

  • attention shift response time [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    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.

  • distance to first cue [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    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.

  • distance to last cue [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    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.

  • spatial resolution decay [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Useful Field of View [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    The UFOV is a neuropsychological task which provides four outputs: visual processing, divided attention, selective attention, and overall risk

  • Trial Making Task [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    The duration of tasks TMT-A and TMT-B are provided in seconds

  • StSoftware driving simulator [ Time Frame: 1 hour post-intervention ] [ Designated as safety issue: No ]
    Standard lateral deviation from the center of the road during the road tracking task, and gain and delay during the car following tasks


Other Outcome Measures:
  • Adverse events [ Time Frame: 1 week after intervention ] [ Designated as safety issue: Yes ]
    New symptoms, accidents, hospitalisation are recorded one week after each visit.


Enrollment: 21
Study Start Date: February 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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.
Other: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Experimental: BAC 0.65 g/L
Cranberry juice with ethanol to rise BAC to 0.65 g/L
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.
Other: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.
Experimental: BAC 0.8 g/L
Cranberry juice with ethanol to rise BAC to 0.8 g/L
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.
Other: Cranberry juice
100 mL cranberry juice is provided in a 250 ml container.

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

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781273

Locations
Switzerland
Institute of Legal Medicine, University of Geneva
Geneva 4, Geneva, Switzerland, 1211
Sponsors and Collaborators
University of Lausanne
University of Lausanne Hospitals
University Hospital, Geneva
Investigators
Principal Investigator: Bernard Favrat, MD CHUV, University of Lausanne
Study Director: Patrice Mangin, MD, PhD CHUV, University of Lausanne
  More Information

Additional Information:
No publications provided

Responsible Party: Bernard Favrat, MD, Head of Unit of Traffic Medicine and Psychology, Principle Investigator, University of Lausanne
ClinicalTrials.gov Identifier: NCT01781273     History of Changes
Other Study ID Numbers: CE-12-277
Study First Received: January 28, 2013
Last Updated: April 20, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne:
impaired driving

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 29, 2014