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Completed

NCT Number: NCT02710578

Alcohol Effects on Driving-related Skills of Young Drivers

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.

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Key information

Age range

19 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alcohol

Drug

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

Drug

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

Other names: Tonic water

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Ontario Ministry of Transportation

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2016
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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