Clinical trial NCT02710578: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psychomotor Impairment
Keywords: Alcohol impaired driving
Driving simulation
Residual effects of alcohol
Acute psychomotor effects of alcohol
Young drivers
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Transportation
First posted: 2016-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Psychomotor impairment (driving)
timeFrame: Approximate Time Frame: 30 minutes before, 30 minutes after, 24 and 48 hours after drinking
Secondary outcomes:
measure: Subjective alcohol effects
timeFrame: Approximate Time Frame: 30 minutes before drinking, 5, 15, 30 minutes and 1, 2, 3, 24 and 48 hours post-drinking
measure: Cognitive testing
timeFrame: Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking
measure: Breath alcohol content (BAC)
timeFrame: Approximate Time Frame: 30 minutes before drinking, 5, 15, 30, minutes and 1, 2, 3, 24, and 48 hours post-drinking
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Robert Mann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: Bernard Le Foll, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: Bruna Brands, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.