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Combined and Separate Effects of Cannabis and Tobacco: Psychomotor, Subjective and Physiological Outcomes (CASE-CT)

Primary Purpose

Driving Under the Influence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cannabis
Tobacco
Cannabis tobacco
Placebo
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Driving Under the Influence

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Adults aged 19 years to 45 years (to control for the effects of age on cognition)

    • Smoke or vape cannabis at least once a month but no more than 4 times a week (to avoid enrolling people with cannabis use disorder who may experience withdrawal when asked to abstain from cannabis)
    • Experience with smoked cannabis in the past year
    • Report use of at least 100 cigarettes in their lifetime to ensure familiarity with the tobacco used in the present study
    • Use of any nicotine (smoked, vaped, etc) in the past year
    • G2 or full G driver's licence for at least a year
    • Willing to abstain from alcohol and other drugs (other than drugs required for treatment of a medical condition) for 48 hours prior to study session
    • Normal heart rate and blood pressure as determined by the QI (because cannabis and tobacco increase heart rate)
    • Normal ECG (because cannabis and tobacco increase heart rate)
    • Willing to abstain from cannabis for 72 hours prior to the test session and from smoking tobacco for 12 hours
    • Willing to use an accepted form of contraception during the study (both males and females)
    • Past lifetime experience with co-use of cannabis or tobacco (either simultaneous or concurrent)
    • Provides written and informed consent

Exclusion Criteria:

  • • Use of psychoactive medications or drugs

    • Current alcohol or other substance use disorder, including cannabis (as assessed with the SCID)
    • Current or past nicotine dependence (to avoid precipitating a relapse)
    • Withdrawal symptoms as assessed with the Marijuana Withdrawal Checklist [57, 58]
    • A score of less than 10 on the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) [59]
    • Family history of schizophrenia or psychosis (to avoid giving cannabis to anyone with a predisposition to psychosis)
    • Respiratory illnesses (due to the smoked route of administration in this study)
    • Any serious medical condition precluding participation as judged by the responsible study physician
    • Pregnancy or breastfeeding
    • Negative urine screen for cannabis at eligibility assessment (to ensure experience with cannabis)
    • Neurological disorders that may affect cognitive function
    • Treatment-seeking for tobacco or cannabis use
    • Use of more than 5 cigarettes a day (to avoid confound of the effects of chronic smoking on measures)
    • Concomitant therapy with sedative-hypnotics or other psychoactive drugs (counter-indicated with cannabis)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    Placebo

    Tobacco

    Cannabis

    Tobacco and cannabis

    Arm Description

    A cigarette containing placebo cannabis and placebo tobacco

    A cigarette with placebo cannabis and active tobacco

    A cigarette with active cannabis and placebo tobacco

    A cigarette with active cannabis and active tobacco

    Outcomes

    Primary Outcome Measures

    Standard deviation of lateral position
    car 'weaving'
    Standard deviation of lateral position
    car 'weaving'
    Standard deviation of lateral position
    car 'weaving'

    Secondary Outcome Measures

    Speed
    Speed (in km) of the car
    Speed
    Speed (in km) of the car
    Speed
    Speed (in km) of the car
    Reaction time
    Time to hit the brake after introduction of an obstacle
    Reaction time
    Time to hit the brake after introduction of an obstacle
    Reaction time
    Time to hit the brake after introduction of an obstacle
    Collisions
    number of times the car hit an obstacle
    Collisions
    number of times the car hit an obstacle
    Collisions
    number of times the car hit an obstacle
    Concentration of THC (ng/ml)
    Psychoactive component of cannabis
    Concentration of THC (ng/ml)
    Psychoactive component of cannabis
    Useful Field of View Processing Speed
    Mean threshold for discriminating stimuli presented in central vision
    Useful Field of View Processing Speed
    Mean threshold for discriminating stimuli presented in central vision
    Useful Field of View Processing Speed
    Mean threshold for discriminating stimuli presented in central vision
    Useful Field of View Divided attention
    Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task
    Useful Field of View Divided attention
    Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task
    Useful Field of View Divided attention
    Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task
    Useful Field of View Selective attention
    Mean threshold for divided attention but with distractors
    Useful Field of View Selective attention
    Mean threshold for divided attention but with distractors
    Useful Field of View Selective attention
    Mean threshold for divided attention but with distractors
    Trail making task
    Cognitive assessment
    Trail making task
    Cognitive assessment
    Trail making task
    Cognitive assessment
    Verbal free recall
    Test of memory
    Verbal free recall
    Test of memory
    Verbal free recall
    Test of memory
    Addiction Research Centre Inventory
    Test of mood with 53 true-false questions that are summed to produce a measure of the intensity of mood, with higher scores reflecting greater mood
    Addiction Research Centre Inventory
    Test of mood with 53 true-false questions that are summed to produce a measure of the intensity of mood, with higher scores reflecting greater mood
    Addiction Research Centre Inventory
    Test of mood with 53 true-false questions that are summed to produce a measure of the intensity of mood, with higher scores reflecting greater mood
    Profile of Mood States
    Test of mood with 76 items with a five point scale that are summed to produce a measure of the intensity of mood, with higher scores indicating more agreemen
    Profile of Mood States
    Test of mood with 76 items with a five point scale that are summed to produce a measure of the intensity of mood, with higher scores indicating more agreemen
    Profile of Mood States
    Test of mood with 76 items with a five point scale that are summed to produce a measure of the intensity of mood, with higher scores indicating more agreemen
    Visual Analog Scale
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Visual Analog Scale
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Visual Analog Scale
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Visual Analog Scale
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Visual Analog Scale
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Visual Analog Scale
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Visual Analog Scale
    test of mood on a scale from 0 to 100, with greater number indicating more agreement

    Full Information

    First Posted
    August 25, 2022
    Last Updated
    September 7, 2023
    Sponsor
    Centre for Addiction and Mental Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05526196
    Brief Title
    Combined and Separate Effects of Cannabis and Tobacco: Psychomotor, Subjective and Physiological Outcomes
    Acronym
    CASE-CT
    Official Title
    Combined and Separate Effects of Cannabis and Tobacco: Psychomotor, Subjective and Physiological Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    February 1, 2027 (Anticipated)
    Study Completion Date
    March 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre for Addiction and Mental Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Co-administration of cannabis and tobacco is a common practice, but there is little experimental evidence aimed at understanding the reasons for this prevalence. Some preliminary evidence suggests that tobacco may actually counteract the cognitive-impairing effects of cannabis, and may also increase the subjective ('liking') effects of cannabis, but results are inconclusive. Further, there are no studies into the effects of tobacco on other cannabis-related harms such as driving, or on the ability of tobacco to alter the blood levels of THC, the chemical responsible for the psychoactive properties of cannabis. The purpose of the present study will be to evaluate the effects of tobacco, cannabis or combinations of tobacco and cannabis on driving, cognition, subjective effects and blood THC. Driving will be assessed using a state-of-the-art driving simulator that allows for the safe and objective measurement of the effects of intoxicating substances on driving. Participants will be regular users of cannabis and will be invited to the lab for four counterbalanced test sessions. In these test sessions they will drive the simulator and undergo cognitive tests before and after smoking: 1) cannabis; 2) tobacco; 3) cannabis + tobacco; or 4) placebo. Outcomes will be measured at several time points after smoking the product. Participants will also give blood for determination of levels of THC, and will complete subjective effects questionnaires both before and after smoking the cigarette. This study will be one of the first experimental laboratory studies of the reasons behind co-administration of tobacco and cannabis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Driving Under the Influence

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Other
    Arm Description
    A cigarette containing placebo cannabis and placebo tobacco
    Arm Title
    Tobacco
    Arm Type
    Other
    Arm Description
    A cigarette with placebo cannabis and active tobacco
    Arm Title
    Cannabis
    Arm Type
    Other
    Arm Description
    A cigarette with active cannabis and placebo tobacco
    Arm Title
    Tobacco and cannabis
    Arm Type
    Other
    Arm Description
    A cigarette with active cannabis and active tobacco
    Intervention Type
    Drug
    Intervention Name(s)
    Cannabis
    Intervention Description
    Dried flower cannabis cigarette with 22% THC
    Intervention Type
    Drug
    Intervention Name(s)
    Tobacco
    Intervention Description
    Dried flower cigarette with active nicotine
    Intervention Type
    Drug
    Intervention Name(s)
    Cannabis tobacco
    Intervention Description
    Dried flower cigarette with active nicotine and cannabis
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Dried flower cigarette with both placebo tobacco and cannabis
    Primary Outcome Measure Information:
    Title
    Standard deviation of lateral position
    Description
    car 'weaving'
    Time Frame
    baseline
    Title
    Standard deviation of lateral position
    Description
    car 'weaving'
    Time Frame
    15 minutes post smoking
    Title
    Standard deviation of lateral position
    Description
    car 'weaving'
    Time Frame
    180 minutes post smoking
    Secondary Outcome Measure Information:
    Title
    Speed
    Description
    Speed (in km) of the car
    Time Frame
    baseline
    Title
    Speed
    Description
    Speed (in km) of the car
    Time Frame
    15 minutes post smoking
    Title
    Speed
    Description
    Speed (in km) of the car
    Time Frame
    180 minutes post smoking
    Title
    Reaction time
    Description
    Time to hit the brake after introduction of an obstacle
    Time Frame
    baseline
    Title
    Reaction time
    Description
    Time to hit the brake after introduction of an obstacle
    Time Frame
    15 minutes post smoking
    Title
    Reaction time
    Description
    Time to hit the brake after introduction of an obstacle
    Time Frame
    180 minutes post smoking
    Title
    Collisions
    Description
    number of times the car hit an obstacle
    Time Frame
    baseline
    Title
    Collisions
    Description
    number of times the car hit an obstacle
    Time Frame
    15 minutes post smoking
    Title
    Collisions
    Description
    number of times the car hit an obstacle
    Time Frame
    180 minutes post smoking
    Title
    Concentration of THC (ng/ml)
    Description
    Psychoactive component of cannabis
    Time Frame
    Baseline
    Title
    Concentration of THC (ng/ml)
    Description
    Psychoactive component of cannabis
    Time Frame
    15 minutes post smoking
    Title
    Useful Field of View Processing Speed
    Description
    Mean threshold for discriminating stimuli presented in central vision
    Time Frame
    baseline
    Title
    Useful Field of View Processing Speed
    Description
    Mean threshold for discriminating stimuli presented in central vision
    Time Frame
    60 minutes post smoking
    Title
    Useful Field of View Processing Speed
    Description
    Mean threshold for discriminating stimuli presented in central vision
    Time Frame
    210 minutes post smoking
    Title
    Useful Field of View Divided attention
    Description
    Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task
    Time Frame
    baseline
    Title
    Useful Field of View Divided attention
    Description
    Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task
    Time Frame
    60 minutes
    Title
    Useful Field of View Divided attention
    Description
    Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task
    Time Frame
    210 minutes
    Title
    Useful Field of View Selective attention
    Description
    Mean threshold for divided attention but with distractors
    Time Frame
    baseline
    Title
    Useful Field of View Selective attention
    Description
    Mean threshold for divided attention but with distractors
    Time Frame
    60 minutes
    Title
    Useful Field of View Selective attention
    Description
    Mean threshold for divided attention but with distractors
    Time Frame
    210 minutes
    Title
    Trail making task
    Description
    Cognitive assessment
    Time Frame
    baseline
    Title
    Trail making task
    Description
    Cognitive assessment
    Time Frame
    60 minutes post smoking
    Title
    Trail making task
    Description
    Cognitive assessment
    Time Frame
    210 minutes post smoking
    Title
    Verbal free recall
    Description
    Test of memory
    Time Frame
    baseline
    Title
    Verbal free recall
    Description
    Test of memory
    Time Frame
    60 minutes post smoking
    Title
    Verbal free recall
    Description
    Test of memory
    Time Frame
    210 minutes post smoking
    Title
    Addiction Research Centre Inventory
    Description
    Test of mood with 53 true-false questions that are summed to produce a measure of the intensity of mood, with higher scores reflecting greater mood
    Time Frame
    baseline
    Title
    Addiction Research Centre Inventory
    Description
    Test of mood with 53 true-false questions that are summed to produce a measure of the intensity of mood, with higher scores reflecting greater mood
    Time Frame
    60 minutes post smoking
    Title
    Addiction Research Centre Inventory
    Description
    Test of mood with 53 true-false questions that are summed to produce a measure of the intensity of mood, with higher scores reflecting greater mood
    Time Frame
    210 minutes post smoking
    Title
    Profile of Mood States
    Description
    Test of mood with 76 items with a five point scale that are summed to produce a measure of the intensity of mood, with higher scores indicating more agreemen
    Time Frame
    baseline
    Title
    Profile of Mood States
    Description
    Test of mood with 76 items with a five point scale that are summed to produce a measure of the intensity of mood, with higher scores indicating more agreemen
    Time Frame
    60 minutes post smoking
    Title
    Profile of Mood States
    Description
    Test of mood with 76 items with a five point scale that are summed to produce a measure of the intensity of mood, with higher scores indicating more agreemen
    Time Frame
    210 minutes post smoking
    Title
    Visual Analog Scale
    Description
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Time Frame
    baseline
    Title
    Visual Analog Scale
    Description
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Time Frame
    15 minutes post smoking
    Title
    Visual Analog Scale
    Description
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Time Frame
    60 minutes post smoking
    Title
    Visual Analog Scale
    Description
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Time Frame
    120 minutes post smoking
    Title
    Visual Analog Scale
    Description
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Time Frame
    180 minutes post smoking
    Title
    Visual Analog Scale
    Description
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Time Frame
    240 minutes post smoking
    Title
    Visual Analog Scale
    Description
    test of mood on a scale from 0 to 100, with greater number indicating more agreement
    Time Frame
    300 minutes post smoking

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Adults aged 19 years to 45 years (to control for the effects of age on cognition) Smoke or vape cannabis at least once a month but no more than 4 times a week (to avoid enrolling people with cannabis use disorder who may experience withdrawal when asked to abstain from cannabis) Experience with smoked cannabis in the past year Report use of at least 100 cigarettes in their lifetime to ensure familiarity with the tobacco used in the present study Use of any nicotine (smoked, vaped, etc) in the past year G2 or full G driver's licence for at least a year Willing to abstain from alcohol and other drugs (other than drugs required for treatment of a medical condition) for 48 hours prior to study session Normal heart rate and blood pressure as determined by the QI (because cannabis and tobacco increase heart rate) Normal ECG (because cannabis and tobacco increase heart rate) Willing to abstain from cannabis for 72 hours prior to the test session and from smoking tobacco for 12 hours Willing to use an accepted form of contraception during the study (both males and females) Past lifetime experience with co-use of cannabis or tobacco (either simultaneous or concurrent) Provides written and informed consent Exclusion Criteria: • Use of psychoactive medications or drugs Current alcohol or other substance use disorder, including cannabis (as assessed with the SCID) Current or past nicotine dependence (to avoid precipitating a relapse) Withdrawal symptoms as assessed with the Marijuana Withdrawal Checklist [57, 58] A score of less than 10 on the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) [59] Family history of schizophrenia or psychosis (to avoid giving cannabis to anyone with a predisposition to psychosis) Respiratory illnesses (due to the smoked route of administration in this study) Any serious medical condition precluding participation as judged by the responsible study physician Pregnancy or breastfeeding Negative urine screen for cannabis at eligibility assessment (to ensure experience with cannabis) Neurological disorders that may affect cognitive function Treatment-seeking for tobacco or cannabis use Use of more than 5 cigarettes a day (to avoid confound of the effects of chronic smoking on measures) Concomitant therapy with sedative-hypnotics or other psychoactive drugs (counter-indicated with cannabis)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patricia Di Ciano
    Phone
    416-535-8501
    Ext
    34002
    Email
    patricia.diciano@camh.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Combined and Separate Effects of Cannabis and Tobacco: Psychomotor, Subjective and Physiological Outcomes

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