Alcohol Effects on Driving-related Skills of Young Drivers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psychomotor Impairment

Intervention / Treatment
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* Drug: Alcohol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alcohol<br>Alcohol | Drug: Alcohol<br>* 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%<br>* Other names: Smirnoff Vodka;|
| Placebo Comparator: Placebo<br>Tonic water | Drug: Placebo<br>* A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.<br>* Other names: Tonic water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor impairment (driving) | The driving simulator will objectively measure changes in driving behaviour after drinking alcohol. | Approximate Time Frame: 30 minutes before, 30 minutes after, 24 and 48 hours after drinking | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective alcohol effects | Visual analogue scale measures how participants feel before and after drinking alcohol. administration. | 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. | Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking | 
| Breath alcohol content (BAC) | Changes in BAC after drinking | Approximate Time Frame: 30 minutes before drinking, 5, 15, 30, minutes and 1, 2, 3, 24, and 48 hours post-drinking | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol impaired driving, Driving simulation, Residual effects of alcohol, Acute psychomotor effects of alcohol, Young drivers