Alcohol Effects on Driving-related Skills of Young Drivers

Centre for Addiction and Mental Health30 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Psychomotor Impairment

Interventions

AlcoholDRUG

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%

PlaceboDRUG

A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Psychomotor impairment (driving)

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 Outcomes

Subjective alcohol effects

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

Cognitive testing

Changes in Continuous Performance Test performance.

Time frame: Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking

Breath alcohol content (BAC)

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

Data from ClinicalTrials.gov

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