Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alcohol Effects on Driving-related Skills of Young Drivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02710578
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
Ontario Ministry of Transportation
Information provided by (Responsible Party):
Robert Mann, Centre for Addiction and Mental Health

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.

Condition or disease Intervention/treatment Phase
Psychomotor Impairment Drug: Alcohol Drug: Placebo Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
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

Arm Intervention/treatment
Active Comparator: Alcohol
Alcohol
Drug: 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
Tonic water
Drug: Placebo
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
Other Name: Tonic water




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females aged 19 to 25.
  • Reported consumption of at least 1 heavy drinking episode (according to NIAAA criteria of 5 drinks for males and 4 for females within an occasion) in the 6 months prior to eligibility assessment.
  • Held a valid class G or G2 Ontario driver's license (or equivalent from another jurisdiction) for at least 12 months.
  • Willing to abstain from alcohol use for the duration of the study, and for 48 hours prior to Session 2.
  • Provides written and informed consent.

Exclusion Criteria:

  • Taking medications or have any medical condition for which alcohol is contraindicated
  • Is a regular user of medications that affect brain function (i.e., antidepressants, benzodiazepines, stimulants).
  • Diagnosis of severe medical or psychiatric conditions.
  • Meets criteria for current or lifetime Substance Use Disorders (DSM-IV) with the exception of nicotine.
  • Meets criteria for Alcohol Dependence (DSM-IV)
  • Is pregnant, is trying to become pregnant, or is currently breastfeeding.
  • Severe allergic reaction to citrus.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Ontario Ministry of Transportation
Investigators
Layout table for investigator information
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
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Robert Mann, Senior Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02710578    
Other Study ID Numbers: 114/2014
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Robert Mann, Centre for Addiction and Mental Health:
Alcohol impaired driving
Driving simulation
Residual effects of alcohol
Acute psychomotor effects of alcohol
Young drivers
Additional relevant MeSH terms:
Layout table for MeSH terms
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases