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Effects of THC and Alcohol on Driving Performance

Primary Purpose

Cannabis, Alcohol Drinking, Accident, Traffic

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
THC 0
THC 5
THC 10
BAC 0
BAC .025
BAC .049
Sponsored by
Lakehead University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cannabis focused on measuring THC, Alcohol, Driving, Dronabinol

Eligibility Criteria

19 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI >18 and <30
  • valid G2 or G Ontario driver's license
  • live on-campus or within 15 minutes drive of campus
  • speak fluent English

Exclusion Criteria:

  • history of cardiovascular or psychiatric disorders
  • current use of psychoactive medication
  • current drug or alcohol abuse problem
  • positive drug screen
  • BAC level > .000%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    THC 0 + BAC 0

    THC 5 + BAC 0

    THC 10 + BAC 0

    THC 5 + BAC .025

    THC 10 + BAC .025

    THC 0 + BAC .049

    THC 5 + BAC .049

    THC 10 + BAC .049

    THC 0 + BAC .025

    Arm Description

    Participants will receive 0mg of THC in combination with blood alcohol concentrations of .000%.

    Participants will receive 5mg of THC in combination with blood alcohol concentrations of .000%.

    Participants will receive 10mg of THC in combination with blood alcohol concentrations of .000%.

    Participants will receive 5mg of THC in combination with blood alcohol concentrations of .025%.

    Participants will receive 125 µg/kg of THC in combination with blood alcohol concentrations of .025%.

    Participants will receive 0 µg/kg of THC in combination with blood alcohol concentrations of .049%.

    Participants will receive 5mg of THC in combination with blood alcohol concentrations of .049%.

    Participants will receive 10mg of THC in combination with blood alcohol concentrations of .049%.

    Participants will receive 0 µg/kg of THC in combination with blood alcohol concentrations of .025%.

    Outcomes

    Primary Outcome Measures

    Demerit Points on Simulated Road Test
    Demerit points incurred for driving errors during a simulated a G2 exit exam (the final step in Ontario's graduated licensing framework) on a STISIM Drive 3-screen driving simulator; demerit points will be assigned in real-time by a member of the research team based on the Ontario Ministry of Transportation scoring scheme

    Secondary Outcome Measures

    Standard Deviation of Lane Position in Meters (STISIM Drive-Recorded Variable)
    Recorded by the STISIM simulator during the simulation
    Mean and Standard Deviation of Velocity in Meters/Second (STISIM Drive-Recorded Variable)
    Recorded by the STISIM simulator during the simulation
    Mean and Standard Deviation of Acceleration in Meters/Second (STISIM Drive-Recorded Variable)
    Recorded by the STISIM simulator during the simulation
    Blood Pressure (Systolic/Diastolic mmHg)
    Systolic & diastolic blood pressure via automated blood pressure cuff
    Heart Rate (BPM) & Heart Rate Variability via ECG
    Continuous heart rate in beats per minute via 3-lead electrocardiography recording; will allow for calculation of heart rate variability)
    Electrical Brain Activity via EEG
    Continuous brain activity via electroencephalography recording
    Median Response Time and Efficiency in Alerting, Orienting & Executive Attention as Measured by the Attention Network Test (in milliseconds)
    A computerized test to measure participants' performance in three separate components of attention: alerting, orienting, and executive attention
    Perceptual Motor Speed & Efficiency as Measured by Time (in seconds) to Complete Trail Making Tests A&B
    A pen and paper test to measure perceptual motor speed and efficiency
    Visual Analogue Scale of Perceived Effects
    Ratings of participants' current perceptions of mood and bodily sensations (22 items including anxiety, alertness, dizziness, dry mouth) driving (3 items related to current willingness to drive), and subjective impairment (at time 2 only; 6 items related to strength of effects, perceived performance on tests); all items measures from not at all>extremely or absent>severe on a 100 mm line

    Full Information

    First Posted
    May 18, 2018
    Last Updated
    April 20, 2022
    Sponsor
    Lakehead University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03555968
    Brief Title
    Effects of THC and Alcohol on Driving Performance
    Official Title
    Determining the Combined Effects of THC and Alcohol on Driving Performance
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Logistical issues
    Study Start Date
    July 2021 (Anticipated)
    Primary Completion Date
    December 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lakehead University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Low blood concentrations of THC and alcohol appear to have a minimal effect on driving performance.However, there is a gap in the literature about the combined effects of THC and alcohol. There is little empirical evidence to determine whether the combination of THC and alcohol could be additive or multiplicative. This issue is particularly important when dealing with concentrations that are just below legal thresholds - it is important to identify if someone who may have consumed cannabis and alcohol, in quantities that do not exceed legal thresholds, may nonetheless be impaired to drive. Answering this question requires more research on the combined effects of THC and alcohol under tightly controlled experimental conditions. Hence, the purpose of this study is to determine the additive (or multiplicative) effect of standardized low doses of cannabis, in combination with low-doses of alcohol, on a number of outcome measures related to driving. The investigators will focus specifically on the effect of low blood concentrations of THC (0, 125, and 250 µg/kg) alone and in combination with low blood concentrations of alcohol (BAC 0%, .025%, and .049%). They shall determine the combined effect of THC and alcohol on physiological, cognitive, subjective measures of impairment, and simulated driving. This study will focus on younger adults because they have higher impaired driving rates than other age groups. As a secondary aim of the study, the investigators will examine whether previous driving and drug use history are correlated with driving decisions during the simulated drive and subjective measures. This study will contribute to the evidence base informing legislation, policy making, and law enforcement. This study is particularly timely given upcoming changes in legislation about cannabis, and because the combination of THC and alcohol, even below legal thresholds, may lead to impaired driving and crashes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cannabis, Alcohol Drinking, Accident, Traffic
    Keywords
    THC, Alcohol, Driving, Dronabinol

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    THC 0 + BAC 0
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive 0mg of THC in combination with blood alcohol concentrations of .000%.
    Arm Title
    THC 5 + BAC 0
    Arm Type
    Experimental
    Arm Description
    Participants will receive 5mg of THC in combination with blood alcohol concentrations of .000%.
    Arm Title
    THC 10 + BAC 0
    Arm Type
    Experimental
    Arm Description
    Participants will receive 10mg of THC in combination with blood alcohol concentrations of .000%.
    Arm Title
    THC 5 + BAC .025
    Arm Type
    Experimental
    Arm Description
    Participants will receive 5mg of THC in combination with blood alcohol concentrations of .025%.
    Arm Title
    THC 10 + BAC .025
    Arm Type
    Experimental
    Arm Description
    Participants will receive 125 µg/kg of THC in combination with blood alcohol concentrations of .025%.
    Arm Title
    THC 0 + BAC .049
    Arm Type
    Experimental
    Arm Description
    Participants will receive 0 µg/kg of THC in combination with blood alcohol concentrations of .049%.
    Arm Title
    THC 5 + BAC .049
    Arm Type
    Experimental
    Arm Description
    Participants will receive 5mg of THC in combination with blood alcohol concentrations of .049%.
    Arm Title
    THC 10 + BAC .049
    Arm Type
    Experimental
    Arm Description
    Participants will receive 10mg of THC in combination with blood alcohol concentrations of .049%.
    Arm Title
    THC 0 + BAC .025
    Arm Type
    Experimental
    Arm Description
    Participants will receive 0 µg/kg of THC in combination with blood alcohol concentrations of .025%.
    Intervention Type
    Drug
    Intervention Name(s)
    THC 0
    Other Intervention Name(s)
    Tetrahydrocannabinol, Dronabinol, Cannabis
    Intervention Description
    THC dose = 0mg
    Intervention Type
    Drug
    Intervention Name(s)
    THC 5
    Other Intervention Name(s)
    Tetrahydrocannabinol, Dronabinol, Cannabis
    Intervention Description
    THC dose = 5mg
    Intervention Type
    Drug
    Intervention Name(s)
    THC 10
    Other Intervention Name(s)
    Tetrahydrocannabinol, Dronabinol, Cannabis
    Intervention Description
    THC dose = 10mg
    Intervention Type
    Other
    Intervention Name(s)
    BAC 0
    Intervention Description
    Blood alcohol concentration = .000%
    Intervention Type
    Other
    Intervention Name(s)
    BAC .025
    Intervention Description
    Blood alcohol concentration = .025%
    Intervention Type
    Other
    Intervention Name(s)
    BAC .049
    Intervention Description
    Blood alcohol concentration = .049%
    Primary Outcome Measure Information:
    Title
    Demerit Points on Simulated Road Test
    Description
    Demerit points incurred for driving errors during a simulated a G2 exit exam (the final step in Ontario's graduated licensing framework) on a STISIM Drive 3-screen driving simulator; demerit points will be assigned in real-time by a member of the research team based on the Ontario Ministry of Transportation scoring scheme
    Time Frame
    @2.5 hours
    Secondary Outcome Measure Information:
    Title
    Standard Deviation of Lane Position in Meters (STISIM Drive-Recorded Variable)
    Description
    Recorded by the STISIM simulator during the simulation
    Time Frame
    @2.5 hours
    Title
    Mean and Standard Deviation of Velocity in Meters/Second (STISIM Drive-Recorded Variable)
    Description
    Recorded by the STISIM simulator during the simulation
    Time Frame
    @2.5 hours
    Title
    Mean and Standard Deviation of Acceleration in Meters/Second (STISIM Drive-Recorded Variable)
    Description
    Recorded by the STISIM simulator during the simulation
    Time Frame
    @2.5 hours
    Title
    Blood Pressure (Systolic/Diastolic mmHg)
    Description
    Systolic & diastolic blood pressure via automated blood pressure cuff
    Time Frame
    @25 minutes and 2 hours
    Title
    Heart Rate (BPM) & Heart Rate Variability via ECG
    Description
    Continuous heart rate in beats per minute via 3-lead electrocardiography recording; will allow for calculation of heart rate variability)
    Time Frame
    Hour 0-3.5
    Title
    Electrical Brain Activity via EEG
    Description
    Continuous brain activity via electroencephalography recording
    Time Frame
    Hour 0-3.5
    Title
    Median Response Time and Efficiency in Alerting, Orienting & Executive Attention as Measured by the Attention Network Test (in milliseconds)
    Description
    A computerized test to measure participants' performance in three separate components of attention: alerting, orienting, and executive attention
    Time Frame
    @25 minutes and 2 hours
    Title
    Perceptual Motor Speed & Efficiency as Measured by Time (in seconds) to Complete Trail Making Tests A&B
    Description
    A pen and paper test to measure perceptual motor speed and efficiency
    Time Frame
    @25 minutes and 2 hours
    Title
    Visual Analogue Scale of Perceived Effects
    Description
    Ratings of participants' current perceptions of mood and bodily sensations (22 items including anxiety, alertness, dizziness, dry mouth) driving (3 items related to current willingness to drive), and subjective impairment (at time 2 only; 6 items related to strength of effects, perceived performance on tests); all items measures from not at all>extremely or absent>severe on a 100 mm line
    Time Frame
    @25 minutes and 2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI >18 and <30 valid G2 or G Ontario driver's license live on-campus or within 15 minutes drive of campus speak fluent English Exclusion Criteria: history of cardiovascular or psychiatric disorders current use of psychoactive medication current drug or alcohol abuse problem positive drug screen BAC level > .000%
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michel Bédard, PhD
    Organizational Affiliation
    Lakehead University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of THC and Alcohol on Driving Performance

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