NCT02710578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2017

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

February 2, 2016

Last Update Submit

January 25, 2019

Conditions

Psychomotor Impairment

Keywords

Alcohol impaired drivingDriving simulationResidual effects of alcoholAcute psychomotor effects of alcoholYoung drivers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Subjective alcohol effects

    Approximate Time Frame: 30 minutes before drinking, 5, 15, 30 minutes and 1, 2, 3, 24 and 48 hours post-drinking

  • Cognitive testing

    Approximate Time Frame: 30 minutes before drinking, and 1, 24 and 48 hours post-drinking

  • 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

Study Arms (2)

Alcohol

ACTIVE COMPARATOR

Alcohol

Drug: Alcohol

Placebo

PLACEBO COMPARATOR

Tonic water

Drug: Placebo

Interventions

AlcoholDRUG

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%

Also known as: Smirnoff Vodka
Alcohol
PlaceboDRUG

A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.

Also known as: Tonic water
Placebo

Eligibility Criteria

Age19 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 20380913BACKGROUND

Related Links

MeSH Terms

Conditions

Psychomotor Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Robert Mann, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

  • Bernard Le Foll, MD, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

  • Bruna Brands, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

February 2, 2016

First Posted

March 17, 2016

Study Start

March 1, 2016

Primary Completion

July 18, 2017

Study Completion

July 18, 2017

Last Updated

January 29, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)