Alcohol Effects on Driving-related Skills of Young Drivers

Psychomotor Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710578
• Other study ID #: 114/2014
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: July 18, 2017

Study information

• Verified date: January 2019
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 18, 2017
• Est. primary completion date: July 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychomotor Impairment

Intervention

Drug:
• Alcohol
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%
• Placebo
A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Ontario Ministry of Transportation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lenné 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cognitive testing	Changes in Continuous Performance Test performance.	Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking
Secondary	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

External Links

•   The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.