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Dose-response of Cannabis and Driving

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ClinicalTrials.gov Identifier: NCT03656029
Recruitment Status : Not yet recruiting
First Posted : September 3, 2018
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Centre for Addiction and Mental Health

Brief Summary:
Epidemiological studies have established a link between collisions while driving and cannabis use. With the changing legal landscape around cannabis, there is much interest in determining per se limits of cannabis while driving. The present study will evaluate driving on a driving simulator after smoking placebo or cannabis with 3 different levels of THC. THC is the active component in cannabis and blood, urine and oral fluid levels of THC will be correlated with driving impairment.

Condition or disease Intervention/treatment Phase
Driving Impaired Cognitive Impairment Abuse Cannabis Drug: Cannabis Drug: Placebo Phase 2

Detailed Description:
Participants will attend the laboratory for 4 separate sessions, separated by about a week. In each session, participants will receive one of 3 doses of smoked cannabis or a placebo. Participants will not know which dose they are receiving. Participants will complete questionnaires, do cognitive tests and drive on a driving simulator before and after smoking the cannabis or placebo cigarette. Blood, urine and oral fluid will be collected throughout the 7-8 hour session to determine levels of THC and its metabolites. These values will be correlated with measures of driving impairment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This will be a within-subjects, counterbalanced, placebo-controlled study of placebo or 3 doses of cannabis
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Dose-dependent Effects of Smoked Cannabis on Simulated Driving Performance
Estimated Study Start Date : June 4, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants will smoke a single smoked placebo (<0.1% THC) cannabis cigarette
Drug: Placebo
Participants will smoke a placebo cigarette

Active Comparator: low dose
Participants will smoke a single low dose (6.25% THC) of smoked cannabis cigarette
Drug: Cannabis
Participants will smoke as much of the cigarette as they wish

Active Comparator: middle dose
Participants will smoke a single intermediate dose (12.5% THC) of smoked cannabis cigarette
Drug: Cannabis
Participants will smoke as much of the cigarette as they wish

Active Comparator: high dose
Participants will smoke a single high dose (22% THC) of smoked cannabis cigarette
Drug: Cannabis
Participants will smoke as much of the cigarette as they wish




Primary Outcome Measures :
  1. Mean speed [ Time Frame: Change in speed of driving between the time before smoking the cigarette and either 30 or 90 minutes after smoking the cigarette ]
    Speed of driving the simulator


Secondary Outcome Measures :
  1. Standard deviation of lateral position [ Time Frame: Change in measure from before smoking the cigarette to either 30 or 90 minutes after smoking ]
    Driving measures

  2. time to collision [ Time Frame: Change in measure from before smoking the cigarette to either 30 or 90 minutes after smoking ]
    Driving measures

  3. following distance [ Time Frame: Change in measure from before smoking the cigarette to either 30 or 90 minutes after smoking ]
    Driving measures

  4. reaction time [ Time Frame: Change in measure from before smoking the cigarette to either 30 or 90 minutes after smoking ]
    Driving measures

  5. Blood concentrations of THC and metabolites [ Time Frame: Change from before smoking cigarette to various time points after smoking: 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 2hours, 3 hours, 4 hours, 5 hours and 6 hours ]
    Blood will be taken to determine how much THC entered the blood

  6. Oral fluid concentrations of THC and metabolites [ Time Frame: Change from levels before smoking to 4 time points after smoking: 30 minutes, 90 minutes, 2 hours and 6 hours ]
    Participants will provide oral fluid to determine how much THC is in the oral fluid

  7. Systolic and Diastolic Blood pressure [ Time Frame: Change from before smoking to a number of time points after smoking: 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 2hours, 3 hours, 4 hours, 5 hours and 6 hours ]
    Vital signs

  8. Heart rate [ Time Frame: Change from before smoking to a number of time points after smoking: 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 2hours, 3 hours, 4 hours, 5 hours and 6 hours ]
    Vital signs

  9. Respirations [ Time Frame: Change from before smoking to a number of time points after smoking: 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 2hours, 3 hours, 4 hours, 5 hours and 6 hours ]
    Vital signs

  10. Temperature [ Time Frame: Change from before smoking to a number of time points after smoking: 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 2hours, 3 hours, 4 hours, 5 hours and 6 hours ]
    Vital signs

  11. Visual Analog Scales [ Time Frame: Change from before smoking to a number of time points after smoking: 5 minutes, 15 minutes, 30 minutes, 60 minutes, 90 minutes, 2hours, 3 hours, 4 hours, 5 hours and 6 hours ]
    Tests designed to assess the degree of subjective effects of the drug. The questions will be scored on a scale from 0 to 100 and will consist of: 'I like this drug effect', 'this feels like cannabis', 'I feel this effect', 'I feel this high', 'I feel the good effects', 'I feel the bad effects', 'I feel the rush'

  12. Verbal free recall test [ Time Frame: Change from pre-smoking levels to those observed 60 minutes after smoking ]
    Test of memory: Participants will be asked to recall words that are read from a list

  13. Useful field of view [ Time Frame: Change from pre-smoking levels to those observed 60 minutes after smoking ]
    A computer test for visual processing speed, selective and divided attention



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Daily or near daily use of cannabis (3-5 days/week) confirmed by self-report and urine screening
  • Has held a class G2 or G licence (or equivalent from another jurisdiction) for at least 12 months
  • Willing to abstain from using cannabis for 72 hours prior to each practice or test session
  • Willing to abstain from alcohol for 48 hours prior to each session, and to abstain from all other drugs not medically required for the duration of the study (beginning 48 hours prior to the practice session)
  • Provides written and informed consent

Exclusion Criteria:

  • Diagnosis of severe medical or psychiatric condition
  • Meets criteria for current or lifetime alcohol or other substance dependence
  • Regular user of medication that may affect cognitive functioning and/or driver performance
  • Family history of schizophrenia or other psychotic disorder
  • Pregnant, looking to become pregnant, or breastfeeding

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): NCT03656029


Contacts
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Contact: Patricia Di Ciano, PhD 416 535-8501 ext 34002 patricia.diciano@camh.ca
Contact: Bruna Brands, PhD 416 535-8501 ext 36860 bruna.brands@camh.ca

Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Bruna Brands, PhD Centre for Addiction and Mental Health

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Responsible Party: Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03656029     History of Changes
Other Study ID Numbers: 007-2018
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Marijuana Abuse
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders