MedDrive's Responsiveness to Alcohol

NCT01781273 | Completed

• 1 other identifier: CE-12-277
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Impaired Driving

Keywords

impaired driving

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• Useful Field of View

  1 hour post-intervention

• Trial Making Task

  1 hour post-intervention

• StSoftware driving simulator

  1 hour post-intervention

Other Outcomes (1)

• Adverse events

  1 week after intervention

Study Arms (4)

Cranberry juice alone

PLACEBO COMPARATOR

500 mL of cranberry juice

Other: Cranberry juice

BAC 0.5 g/L

EXPERIMENTAL

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

Other: Ethanol; Other: Cranberry juice

BAC 0.65 g/L

EXPERIMENTAL

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

Other: Ethanol; Other: Cranberry juice

BAC 0.8 g/L

EXPERIMENTAL

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

Other: Ethanol; Other: Cranberry juice

Interventions

Ethanol 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.

BAC 0.5 g/L; BAC 0.65 g/L; BAC 0.8 g/L

Cranberry juice OTHER

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

BAC 0.5 g/L; BAC 0.65 g/L; BAC 0.8 g/L; Cranberry juice alone

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lausanne: lead
• University of Lausanne Hospitals: collaborator
• University Hospital, Geneva: collaborator

Study Sites (1)

Institute of Legal Medicine, University of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Bernard Favrat, MD

  CHUV, University of Lausanne

  PRINCIPAL INVESTIGATOR

• Patrice Mangin, MD, PhD

  CHUV, University of Lausanne

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Unit of Traffic Medicine and Psychology, Principle Investigator

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 31, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

CH (1)