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Alcohol Effects on Driving-related Skills of Young Drivers

Primary Purpose

Psychomotor Impairment

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Alcohol
Placebo
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psychomotor Impairment focused on measuring Alcohol impaired driving, Driving simulation, Residual effects of alcohol, Acute psychomotor effects of alcohol, Young drivers

Eligibility Criteria

19 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alcohol

Placebo

Arm Description

Alcohol

Tonic water

Outcomes

Primary Outcome Measures

Psychomotor impairment (driving)
The driving simulator will objectively measure changes in driving behaviour after drinking alcohol.

Secondary Outcome Measures

Subjective alcohol effects
Visual analogue scale measures how participants feel before and after drinking alcohol. administration.
Cognitive testing
Changes in Continuous Performance Test performance.
Breath alcohol content (BAC)
Changes in BAC after drinking

Full Information

First Posted
February 2, 2016
Last Updated
January 25, 2019
Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Ministry of Transportation
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1. Study Identification

Unique Protocol Identification Number
NCT02710578
Brief Title
Alcohol Effects on Driving-related Skills of Young Drivers
Official Title
Acute and Residual Effects of Alcohol on Young Drivers' Performance of Driving Related Skills
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 18, 2017 (Actual)
Study Completion Date
July 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Ontario Ministry of Transportation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychomotor Impairment
Keywords
Alcohol impaired driving, Driving simulation, Residual effects of alcohol, Acute psychomotor effects of alcohol, Young drivers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alcohol
Arm Type
Active Comparator
Arm Description
Alcohol
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tonic water
Intervention Type
Drug
Intervention Name(s)
Alcohol
Other Intervention Name(s)
Smirnoff Vodka
Intervention Description
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%
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Tonic water
Intervention Description
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
Primary Outcome Measure Information:
Title
Psychomotor impairment (driving)
Description
The driving simulator will objectively measure changes in driving behaviour after drinking alcohol.
Time Frame
Approximate Time Frame: 30 minutes before, 30 minutes after, 24 and 48 hours after drinking
Secondary Outcome Measure Information:
Title
Subjective alcohol effects
Description
Visual analogue scale measures how participants feel before and after drinking alcohol. administration.
Time Frame
Approximate Time Frame: 30 minutes before drinking, 5, 15, 30 minutes and 1, 2, 3, 24 and 48 hours post-drinking
Title
Cognitive testing
Description
Changes in Continuous Performance Test performance.
Time Frame
Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking
Title
Breath alcohol content (BAC)
Description
Changes in BAC after drinking
Time Frame
Approximate Time Frame: 30 minutes before drinking, 5, 15, 30, minutes and 1, 2, 3, 24, and 48 hours post-drinking

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Mann, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernard Le Foll, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruna Brands, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20380913
Citation
Lenne MG, Dietze PM, Triggs TJ, Walmsley S, Murphy B, Redman JR. The effects of cannabis and alcohol on simulated arterial driving: Influences of driving experience and task demand. Accid Anal Prev. 2010 May;42(3):859-66. doi: 10.1016/j.aap.2009.04.021.
Results Reference
background
Links:
URL
http://www.camh.ca/en/research
Description
The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.

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Alcohol Effects on Driving-related Skills of Young Drivers

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