Effects of Alcohol on Simulated Driving

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477984
• Other study ID #: 06-221/O
• Status: Completed
• Phase: N/A
• First received: May 23, 2007
• Last updated: April 11, 2008
• Start date: May 2007
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: Utrecht Institute for Pharmaceutical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• alcohol
alcohol(0.02%, 0.05%, 0.08% and 0.10%) and placebo

Locations

Country	Name	City	State
Netherlands	Utrecht Institute for Pharmaceutical Sciences	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Utrecht Institute for Pharmaceutical Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary parameter of the steering simulator is the standard deviation of the car from the center of the road (steering error).		5 testdays	No
Secondary	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	No