Calibration and Validation of the STISIM Driving Simulator

Calibration and Validation of the STISIM Driving Simulator: Simulated Driving Performance Under the Influence of Alcohol (0.05%, 0.08% AND 0.11%), and Placebo

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00720551

Enrollment

Registered

2008-07-22

Start date

2008-06-30

Completion date

2009-02-28

Last updated

2009-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simulated Driving Performance

Keywords

STISIM, Alcohol

Brief 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.

Interventions

OTHERalcohol

alcohol 0.05%, 0.08% or 0.11% or placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Standard Deviation of the Lateral Position (SDLP)	one day

Secondary

Measure	Time frame
Number of collisions and traffic violations	20 minutes

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026