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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05526196
Other study ID # 130-2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2024
Est. completion date March 1, 2027

Study information

Verified date September 2023
Source Centre for Addiction and Mental Health
Contact Patricia Di Ciano
Phone 416-535-8501
Email patricia.diciano@camh.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date March 1, 2027
Est. primary completion date February 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 45 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cannabis
Dried flower cannabis cigarette with 22% THC
Tobacco
Dried flower cigarette with active nicotine
Cannabis tobacco
Dried flower cigarette with active nicotine and cannabis
Placebo
Dried flower cigarette with both placebo tobacco and cannabis

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Outcome

Type Measure Description Time frame Safety issue
Primary Standard deviation of lateral position car 'weaving' baseline
Primary Standard deviation of lateral position car 'weaving' 15 minutes post smoking
Primary Standard deviation of lateral position car 'weaving' 180 minutes post smoking
Secondary Speed Speed (in km) of the car baseline
Secondary Speed Speed (in km) of the car 15 minutes post smoking
Secondary Speed Speed (in km) of the car 180 minutes post smoking
Secondary Reaction time Time to hit the brake after introduction of an obstacle baseline
Secondary Reaction time Time to hit the brake after introduction of an obstacle 15 minutes post smoking
Secondary Reaction time Time to hit the brake after introduction of an obstacle 180 minutes post smoking
Secondary Collisions number of times the car hit an obstacle baseline
Secondary Collisions number of times the car hit an obstacle 15 minutes post smoking
Secondary Collisions number of times the car hit an obstacle 180 minutes post smoking
Secondary Concentration of THC (ng/ml) Psychoactive component of cannabis Baseline
Secondary Concentration of THC (ng/ml) Psychoactive component of cannabis 15 minutes post smoking
Secondary Useful Field of View Processing Speed Mean threshold for discriminating stimuli presented in central vision baseline
Secondary Useful Field of View Processing Speed Mean threshold for discriminating stimuli presented in central vision 60 minutes post smoking
Secondary Useful Field of View Processing Speed Mean threshold for discriminating stimuli presented in central vision 210 minutes post smoking
Secondary Useful Field of View Divided attention Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task baseline
Secondary Useful Field of View Divided attention Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task 60 minutes
Secondary Useful Field of View Divided attention Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task 210 minutes
Secondary Useful Field of View Selective attention Mean threshold for divided attention but with distractors baseline
Secondary Useful Field of View Selective attention Mean threshold for divided attention but with distractors 60 minutes
Secondary Useful Field of View Selective attention Mean threshold for divided attention but with distractors 210 minutes
Secondary Trail making task Cognitive assessment baseline
Secondary Trail making task Cognitive assessment 60 minutes post smoking
Secondary Trail making task Cognitive assessment 210 minutes post smoking
Secondary Verbal free recall Test of memory baseline
Secondary Verbal free recall Test of memory 60 minutes post smoking
Secondary Verbal free recall Test of memory 210 minutes post smoking
Secondary 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 baseline
Secondary 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 60 minutes post smoking
Secondary 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 210 minutes post smoking
Secondary 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 baseline
Secondary 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 60 minutes post smoking
Secondary 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 210 minutes post smoking
Secondary Visual Analog Scale test of mood on a scale from 0 to 100, with greater number indicating more agreement baseline
Secondary Visual Analog Scale test of mood on a scale from 0 to 100, with greater number indicating more agreement 15 minutes post smoking
Secondary Visual Analog Scale test of mood on a scale from 0 to 100, with greater number indicating more agreement 60 minutes post smoking
Secondary Visual Analog Scale test of mood on a scale from 0 to 100, with greater number indicating more agreement 120 minutes post smoking
Secondary Visual Analog Scale test of mood on a scale from 0 to 100, with greater number indicating more agreement 180 minutes post smoking
Secondary Visual Analog Scale test of mood on a scale from 0 to 100, with greater number indicating more agreement 240 minutes post smoking
Secondary Visual Analog Scale test of mood on a scale from 0 to 100, with greater number indicating more agreement 300 minutes post smoking
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