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
About this trial
This is an interventional basic science trial for Driving Under the Influence
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)
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
NCT ID
NCT05526196
First Posted
August 25, 2022
Last Updated
September 7, 2023
Sponsor
Centre for Addiction and Mental Health
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
Learn more about this trial
Combined and Separate Effects of Cannabis and Tobacco: Psychomotor, Subjective and Physiological Outcomes
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