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Effects of Alcohol on Simulated Driving

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
alcohol
Sponsored by
Utrecht Institute for Pharmaceutical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcoholism focused on measuring Alcohol, Driving, Multitasking, ERP, social drinkers

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Utrecht Institute for Pharmaceutical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

alcohol and placebo

Outcomes

Primary Outcome Measures

Primary parameter of the steering simulator is the standard deviation of the car from the center of the road (steering error).

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2007
Last Updated
April 11, 2008
Sponsor
Utrecht Institute for Pharmaceutical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00477984
Brief Title
Effects of Alcohol on Simulated Driving
Official Title
The Effects of Five Dosages of Ethanol on Simulated Driving Performance and Event-Related Potentials
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Utrecht Institute for Pharmaceutical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcohol, Driving, Multitasking, ERP, social drinkers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
alcohol and placebo
Intervention Type
Drug
Intervention Name(s)
alcohol
Other Intervention Name(s)
alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo
Intervention Description
alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joris C Verster, PhD
Organizational Affiliation
Utrecht Institute for Pharmaceutical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edmund R Volkerts, PhD
Organizational Affiliation
Utrecht Institute for Pharmaceutical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Utrecht Institute for Pharmaceutical Sciences
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

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Effects of Alcohol on Simulated Driving

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