Clincosm LogoSign in Get a demo

Effects of THC and Alcohol on Driving Performance

Sponsor
Lakehead University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03555968
Collaborator
(none)
0
Enrollment
9
Arms
5
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: THC 0
  • Drug: THC 5
  • Drug: THC 10
  • Other: BAC 0
  • Other: BAC .025
  • Other: BAC .049
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Determining the Combined Effects of THC and Alcohol on Driving Performance
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: THC 0 + BAC 0

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

Drug: THC 0
THC dose = 0mg
Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

    • Other: BAC 0
    Blood alcohol concentration = .000%
    Experimental: THC 5 + BAC 0

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

    Drug: THC 5
    THC dose = 5mg
    Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

    • Other: BAC 0
    Blood alcohol concentration = .000%
    Experimental: THC 10 + BAC 0

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

    Drug: THC 10
    THC dose = 10mg
    Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

    • Other: BAC 0
    Blood alcohol concentration = .000%
    Experimental: THC 5 + BAC .025

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

    Drug: THC 5
    THC dose = 5mg
    Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

    • Other: BAC .025
    Blood alcohol concentration = .025%
    Experimental: THC 10 + BAC .025

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

    Drug: THC 5
    THC dose = 5mg
    Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

    • Other: BAC .025
    Blood alcohol concentration = .025%
    Experimental: THC 0 + BAC .049

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

    Drug: THC 0
    THC dose = 0mg
    Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

    • Drug: THC 10
    THC dose = 10mg
    Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

    • Other: BAC .025
    Blood alcohol concentration = .025%

    Other: BAC .049
    Blood alcohol concentration = .049%
    Experimental: THC 5 + BAC .049

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

    Drug: THC 5
    THC dose = 5mg
    Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

    • Other: BAC .049
    Blood alcohol concentration = .049%
    Experimental: THC 10 + BAC .049

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

    Drug: THC 5
    THC dose = 5mg
    Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

    • Other: BAC .049
    Blood alcohol concentration = .049%
    Experimental: THC 0 + BAC .025

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

    Drug: THC 0
    THC dose = 0mg
    Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

    • Drug: THC 10
    THC dose = 10mg
    Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

    • Other: BAC .025
    Blood alcohol concentration = .025%

    Other: BAC .049
    Blood alcohol concentration = .049%

    Outcome Measures

    Primary Outcome Measures

    1. Demerit Points on Simulated Road Test [@2.5 hours]

      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

    1. Standard Deviation of Lane Position in Meters (STISIM Drive-Recorded Variable) [@2.5 hours]

      Recorded by the STISIM simulator during the simulation

    2. Mean and Standard Deviation of Velocity in Meters/Second (STISIM Drive-Recorded Variable) [@2.5 hours]

      Recorded by the STISIM simulator during the simulation

    3. Mean and Standard Deviation of Acceleration in Meters/Second (STISIM Drive-Recorded Variable) [@2.5 hours]

      Recorded by the STISIM simulator during the simulation

    4. Blood Pressure (Systolic/Diastolic mmHg) [@25 minutes and 2 hours]

      Systolic & diastolic blood pressure via automated blood pressure cuff

    5. Heart Rate (BPM) & Heart Rate Variability via ECG [Hour 0-3.5]

      Continuous heart rate in beats per minute via 3-lead electrocardiography recording; will allow for calculation of heart rate variability)

    6. Electrical Brain Activity via EEG [Hour 0-3.5]

      Continuous brain activity via electroencephalography recording

    7. Median Response Time and Efficiency in Alerting, Orienting & Executive Attention as Measured by the Attention Network Test (in milliseconds) [@25 minutes and 2 hours]

      A computerized test to measure participants' performance in three separate components of attention: alerting, orienting, and executive attention

    8. Perceptual Motor Speed & Efficiency as Measured by Time (in seconds) to Complete Trail Making Tests A&B [@25 minutes and 2 hours]

      A pen and paper test to measure perceptual motor speed and efficiency

    9. Visual Analogue Scale of Perceived Effects [@25 minutes and 2 hours]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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%

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lakehead University

    Investigators

    • Principal Investigator: Michel Bédard, PhD, Lakehead University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lakehead University
    ClinicalTrials.gov Identifier:
    NCT03555968
    Other Study ID Numbers:
    • 2018502
    First Posted:
    Jun 14, 2018
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Lakehead University
    THC
    Alcohol
    Driving
    Dronabinol
    Additional relevant MeSH terms:
    Alcohol Drinking
    Dronabinol

    Study Results

    No Results Posted as of Apr 25, 2022