Alcohol Effects on Driving-related Skills of Young Drivers
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|ClinicalTrials.gov Identifier: NCT02710578|
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psychomotor Impairment||Drug: Alcohol Drug: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Acute and Residual Effects of Alcohol on Young Drivers' Performance of Driving Related Skills|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||July 18, 2017|
|Actual Study Completion Date :||July 18, 2017|
Active Comparator: Alcohol
A single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol (Vodka) to tonic water to obtain a target BAC of 0.08mg%
Other Name: Smirnoff Vodka
Placebo Comparator: Placebo
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
Other Name: Tonic water
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710578
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5S 2S1|
|Principal Investigator:||Robert Mann, PhD||Centre for Addiction and Mental Health|
|Principal Investigator:||Bernard Le Foll, MD, PhD||Centre for Addiction and Mental Health|
|Principal Investigator:||Bruna Brands, PhD||Centre for Addiction and Mental Health|