Clinical Trial: Alcohol Effects on Driving-related Skills of Young Drivers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Acute and Residual Effects of Alcohol on Young Drivers' Performance of Driving Related Skills

Brief Summary: Given the known driving behavior of Driving Under the Influence of Alcohol and some of its parallel to driving under the influence of cannabis, this supplemental study aims to validate the sensitivity of the primary and secondary outcome measures employed in a cannabis and driving study currently in progress.

Detailed Summary:

This study will examine the effects of an intoxicating dose of alcohol on driving-related skills among young drivers using driving simulator technology.

This study is a double-blind, placebo-controlled mixed design study, including randomized between-subjects comparison of the effects of alcohol intoxication and both between- and within-subjects examination of acute and residual effects at approximately 24 and 48 hours following one-time alcohol administration.

Initial contact with potential participants will be made by telephone, where study personnel will conduct a telephone screen for eligibility. Those telephone screened as eligible will attend CAMH for an eligibility assessment. Enrolled participants will complete four sessions on consecutive days: a practice day, an alcohol administration day, and a 24-hour and 48-hour post-alcohol session.


Sponsor: Centre for Addiction and Mental Health

Current Primary Outcome: Psychomotor impairment (driving) [ Time Frame: Approximate Time Frame: 30 minutes before, 30 minutes after, 24 and 48 hours after drinking ]

The driving simulator will objectively measure changes in driving behaviour after drinking alcohol.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Subjective alcohol effects [ Time Frame: Approximate Time Frame: 30 minutes before drinking, 5, 15, 30 minutes and 1, 2, 3, 24 and 48 hours post-drinking ]
    Visual analogue scale measures how participants feel before and after drinking alcohol. administration.
  • Cognitive testing [ Time Frame: Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking ]
    Changes in Continuous Performance Test performance.
  • Breath alcohol content (BAC) [ Time Frame: Approximate Time Frame: 30 minutes before drinking, 5, 15, 30, minutes and 1, 2, 3, 24, and 48 hours post-drinking ]
    Changes in BAC after drinking


Original Secondary Outcome: Same as current

Information By: Centre for Addiction and Mental Health

Dates:
Date Received: February 2, 2016
Date Started: March 2016
Date Completion: August 2017
Last Updated: March 20, 2017
Last Verified: March 2017