Effects of Alcohol on Simulated Driving

April 11, 2008 updated by: Utrecht Institute for Pharmaceutical Sciences

The Effects of Five Dosages of Ethanol on Simulated Driving Performance and Event-Related Potentials

Previous studies have shown that alcohol significantly impairs driving performance. Acute alcohol administration also has a detrimental effect on secondary task performance during dual-tasks. The present study will investigate the effects of five different dosages of ethanol (0,0.2, 0,5, 0,8 and 1,0 % BAC) on performance in a driving simulator. Steering performance and brain activity will be recorded in both single- and dual-task conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands
        • Utrecht Institute for Pharmaceutical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • He/she is aged between 21-50
  • Written informed consent
  • Right-handed
  • Normal static binocular acuity, corrected or uncorrected
  • Normal hearing
  • Social Drinker (average of 7 to 21 alcoholic drinks per week)
  • Possession of a drivers license
  • Be considered as reliable and mentally capable of adhering to the protocol.

Exclusion Criteria:

  • Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
  • Positive urine pregnancy drug screen in women
  • Use of psychoactive medication
  • Positive alcohol breath test
  • Prior enrolment 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
alcohol and placebo
Drug: alcohol
alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo
Other Names:
  • alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary parameter of the steering simulator is the standard deviation of the car from the center of the road (steering error).
Time Frame: 5 testdays
5 testdays

Secondary Outcome Measures

Outcome Measure
Time Frame
Reaction speed after hearing the deviant target tone. Brain activity: ERPs of interest are the mismatch negativity (MMN), P3a, P3b, and reorienting negativity (RON)
Time Frame: 5 testdays
5 testdays

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Utrecht Institute for Pharmaceutical Sciences

Investigators

  • Principal Investigator: Joris C Verster, PhD, Utrecht Institute for Pharmaceutical Sciences
  • Study Director: Edmund R Volkerts, PhD, Utrecht Institute for Pharmaceutical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 23, 2007

First Submitted That Met QC Criteria

May 23, 2007

First Posted (Estimate)

May 24, 2007

Study Record Updates

Last Update Posted (Estimate)

April 15, 2008

Last Update Submitted That Met QC Criteria

April 11, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-221/O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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