Calibration and Validation of the STISIM Driving Simulator

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Simulated Driving Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Interventions

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alcohol

alcohol 0.05%, 0.08% or 0.11% or placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 21-50 years old
* Written informed consent
* Normal static binocular acuity, corrected or uncorrected
* Normal hearing
* Social Drinker (average of 7 to 21 alcoholic drinks per week and experience with drinking 4-6 drinks per occasion)
* No current or past drug use
* Possession of a driver's license for at least 3 years
* Be considered as reliable and mentally capable of adhering to the protocol

Exclusion Criteria

* Current and past drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
* Positive urine pregnancy screen in women
* Present use of psychoactive medication
* Positive alcohol breath test
* Prior enrollment in the same study
* Physical or mental illness
* Excessive alcohol use ( \> 21 alcoholic drinks per week)
* Excessive smoking (more than 10 cigarettes per day)
* Intake of caffeine-containing beverages over 5 glasses per day
* Simulator sickness, as determined during the training session

Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes