Effects of Alcohol on Simulated Driving
The Effects of Five Dosages of Ethanol on Simulated Driving Performance and Event-Related Potentials
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 23, 2007
CompletedFirst Posted
Study publicly available on registry
May 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedApril 15, 2008
April 1, 2008
10 months
May 23, 2007
April 11, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary parameter of the steering simulator is the standard deviation of the car from the center of the road (steering error).
5 testdays
Secondary Outcomes (1)
Reaction speed after hearing the deviant target tone. Brain activity: ERPs of interest are the mismatch negativity (MMN), P3a, P3b, and reorienting negativity (RON)
5 testdays
Study Arms (1)
A
EXPERIMENTALalcohol and placebo
Interventions
alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Utrecht Institute for Pharmaceutical Sciences
Utrecht, Utrecht, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joris C Verster, PhD
Utrecht Institute for Pharmaceutical Sciences
- STUDY DIRECTOR
Edmund R Volkerts, PhD
Utrecht Institute for Pharmaceutical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 23, 2007
First Posted
May 24, 2007
Study Start
May 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
April 15, 2008
Record last verified: 2008-04