Alcohol Effects on Driving-related Skills of Young Drivers (NCT02710578) | Clinical Trial Compass
CompletedNot Applicable
Alcohol Effects on Driving-related Skills of Young Drivers
Canada30 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range
19 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Psychomotor impairment (driving)
Timeframe: Approximate Time Frame: 30 minutes before, 30 minutes after, 24 and 48 hours after drinking