Alcohol Effects on Driving-related Skills of Young Drivers

January 25, 2019 updated by: Robert Mann, Centre for Addiction and Mental Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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 Names:
  • 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 Names:
  • Tonic water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximate Time Frame: 30 minutes before, 30 minutes after, 24 and 48 hours after drinking

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximate Time Frame: 30 minutes before drinking, 5, 15, 30 minutes and 1, 2, 3, 24 and 48 hours post-drinking
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.
Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking
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
Approximate Time Frame: 30 minutes before drinking, 5, 15, 30, minutes and 1, 2, 3, 24, and 48 hours post-drinking

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

Ontario Ministry of Transportation

Investigators

  • Principal Investigator: Robert Mann, PhD, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ACTUAL)

July 18, 2017

Study Completion (ACTUAL)

July 18, 2017

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (ESTIMATE)

March 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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