MedTrace Logo

MedDrive's Responsiveness to Alcohol

NCT01781273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2013-04-23

No results posted yet for this study

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.

Conditions

  • Impaired Driving

Interventions

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.

Sponsors & Collaborators

  • University of Lausanne Hospitals

    collaborator OTHER

  • University Hospital, Geneva

    collaborator OTHER

  • University of Lausanne

    lead OTHER

Principal Investigators

  • Bernard Favrat, MD · CHUV, University of Lausanne

  • Patrice Mangin, MD, PhD · CHUV, University of Lausanne

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01781273 on ClinicalTrials.gov