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Calibration and Validation of the STISIM Driving Simulator

NCT00720551 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2009-02-13

No results posted yet for this study

Summary

The aim of this study is to calibrate the STISIM driving simulator under influence of three different dosages of ethanol (0.05%, 0.08% and 0.11% BAC). The levels of performance decrement for the three blood alcohol concentrations will serve as a standard for comparing the effects that will be observed with psychoactive drugs in future trials. This will make the results of these future studies more easily to interpret and will provide health care providers and policy makers who read our scientific work with an easy-to-understand and clinically relevant comparison.

Conditions

  • Simulated Driving Performance

Interventions

OTHER

alcohol

alcohol 0.05%, 0.08% or 0.11% or placebo

Sponsors & Collaborators

  • Utrecht Institute for Pharmaceutical Sciences

    lead OTHER

Principal Investigators

  • Joris C Verster, PhD · Utrecht University

  • Lieke M de Senerpont Domis, MSc · Utrecht University

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Netherlands

Study Locations

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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 NCT00720551 on ClinicalTrials.gov