Calibration and Validation of the STISIM Driving Simulator

This study has been completed.

First Received: July 18, 2008 Last Updated: February 12, 2009 History of Changes

Sponsored by:	Utrecht Institute for Pharmaceutical Sciences
Information provided by:	Utrecht Institute for Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT00720551

Purpose

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.

Condition	Intervention
Simulated Driving Performance	Other: alcohol

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Ethanol

U.S. FDA Resources

Further study details as provided by Utrecht Institute for Pharmaceutical Sciences:

Primary Outcome Measures:

Standard Deviation of the Lateral Position (SDLP) [ Time Frame: one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of collisions and traffic violations [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	June 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

alcohol 0.05%, 0.08% or 0.11% or placebo

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720551

Locations

Netherlands
Utrecht University, Section Psychopharmacology
Utrecht, Netherlands, 3508 TB

Sponsors and Collaborators

Utrecht Institute for Pharmaceutical Sciences

Investigators

Principal Investigator:	Joris C Verster, PhD	Utrecht University
Study Director:	Lieke M de Senerpont Domis, MSc	Utrecht University

More Information

No publications provided

Responsible Party:	Utrecht University ( Dr. J.C. Verster )
Study ID Numbers:	07-374
Study First Received:	July 18, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00720551 History of Changes
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Utrecht Institute for Pharmaceutical Sciences:

STISIM
Alcohol

Study placed in the following topic categories:

Ethanol

ClinicalTrials.gov processed this record on September 09, 2009