Alcohol Effects on Driving-related Skills of Young Drivers

Sponsor

Centre for Addiction and Mental Health (Other)

Overall Status

Completed

CT.gov ID

NCT02710578

Collaborator

Ontario Ministry of Transportation (Other)

Enrollment

Location

Arms

16.6

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psychomotor Impairment	Drug: Alcohol Drug: Placebo	N/A

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 Design

Study Type:

Interventional

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 :

Mar 1, 2016

Actual Primary Completion Date :

Jul 18, 2017

Actual Study Completion Date :

Jul 18, 2017

Arms and Interventions

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 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

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 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

Outcome Measures

Primary Outcome Measures

Psychomotor impairment (driving) [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

Subjective alcohol effects [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 [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) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

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