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Effects of THC and Alcohol on Driving Performance

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ClinicalTrials.gov Identifier: NCT03555968
Recruitment Status : Not yet recruiting
First Posted : June 14, 2018
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
Ontario Ministry of Transportation
Information provided by (Responsible Party):
Lakehead University

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
Cannabis Alcohol Drinking Accident, Traffic Drug: THC 0 Drug: THC 125 Drug: THC 250 Other: BAC 0 Other: BAC .025 Other: BAC .049 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 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
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Placebo Comparator: THC 0 + BAC 0
Participants will receive 0 µg/kg of THC in combination with blood alcohol concentrations of .000%.
Drug: THC 0
THC dose = 0 ug/kg
Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

Other: BAC 0
Blood alcohol concentration = .000%

Experimental: THC 125 + BAC 0
Participants will receive 125 µg/kg of THC in combination with blood alcohol concentrations of .000%.
Drug: THC 125
THC dose = 125 ug/kg
Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

Other: BAC 0
Blood alcohol concentration = .000%

Experimental: THC 250 + BAC 0
Participants will receive 250 µg/kg of THC in combination with blood alcohol concentrations of .000%.
Drug: THC 250
THC dose = 250 ug/kg
Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

Other: BAC 0
Blood alcohol concentration = .000%

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 = 0 ug/kg
Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

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

Experimental: THC 125 + BAC .025
Participants will receive 125 µg/kg of THC in combination with blood alcohol concentrations of .025%.
Drug: THC 125
THC dose = 125 ug/kg
Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

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

Experimental: THC 250 + BAC .025
Participants will receive 250 µg/kg of THC in combination with blood alcohol concentrations of .025%.
Drug: THC 250
THC dose = 250 ug/kg
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 = 0 ug/kg
Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

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

Experimental: THC 125 + BAC .049
Participants will receive 125 µg/kg of THC in combination with blood alcohol concentrations of .049%.
Drug: THC 125
THC dose = 125 ug/kg
Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

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

Experimental: THC 250 + BAC .049
Participants will receive 250 µg/kg of THC in combination with blood alcohol concentrations of .049%.
Drug: THC 250
THC dose = 250 ug/kg
Other Names:
  • Tetrahydrocannabinol
  • Dronabinol
  • Cannabis

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




Primary Outcome Measures :
  1. Demerit Points on Simulated Road Test [ Time Frame: @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) [ Time Frame: @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) [ Time Frame: @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) [ Time Frame: @2.5 hours ]
    Recorded by the STISIM simulator during the simulation

  4. Blood Pressure (Systolic/Diastolic mmHg) [ Time Frame: @25 minutes and 2 hours ]
    Systolic & diastolic blood pressure via automated blood pressure cuff

  5. Heart Rate (BPM) & Heart Rate Variability via ECG [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: @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 [ Time Frame: @25 minutes and 2 hours ]
    A pen and paper test to measure perceptual motor speed and efficiency

  9. Visual Analogue Scale of Perceived Effects [ Time Frame: @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



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555968


Contacts
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Contact: Hillary Maxwell, MPH 8077667208 hmaxwell@lakeheadu.ca
Contact: Nadia Mullen, PhD 8077667249 nmullen@lakeheadu.ca

Sponsors and Collaborators
Lakehead University
Ontario Ministry of Transportation
Investigators
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Principal Investigator: Michel Bédard, PhD Lakehead University

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Responsible Party: Lakehead University
ClinicalTrials.gov Identifier: NCT03555968     History of Changes
Other Study ID Numbers: 2018502
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Alcohol Drinking
Drinking Behavior
Ethanol
Dronabinol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists