Psychomotor Impairment
Conditions
Keywords
Alcohol impaired driving, Driving simulation, Residual effects of alcohol, Acute psychomotor effects of alcohol, Young drivers
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.
Interventions
DRUGAlcohol
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%
DRUGPlacebo
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
Sponsors
Ontario Ministry of Transportation
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 25 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed