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NCT Number: NCT05526196

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

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.

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Key information

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location status: Recruiting

Location contact

Patricia Di Ciano, PhD

CONTACT

[email protected]

416 535-8501 ext. 34002

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cannabis

Drug

Dried flower cannabis cigarette with 22% THC

Tobacco

Drug

Dried flower cigarette with active nicotine

Cannabis tobacco

Drug

Dried flower cigarette with active nicotine and cannabis

Placebo

Drug

Dried flower cigarette with both placebo tobacco and cannabis

Primary outcomes

  1. Standard deviation of lateral position

    Time frame: baseline

    car 'weaving'

  2. Standard deviation of lateral position

    Time frame: 15 minutes post smoking

    car 'weaving'

  3. Standard deviation of lateral position

    Time frame: 180 minutes post smoking

    car 'weaving'

Secondary outcomes

  1. Speed

    Time frame: baseline

    Speed (in km) of the car

  2. Speed

    Time frame: 15 minutes post smoking

    Speed (in km) of the car

  3. Speed

    Time frame: 180 minutes post smoking

    Speed (in km) of the car

  4. Reaction time

    Time frame: baseline

    Time to hit the brake after introduction of an obstacle

  5. Reaction time

    Time frame: 15 minutes post smoking

    Time to hit the brake after introduction of an obstacle

  6. Reaction time

    Time frame: 180 minutes post smoking

    Time to hit the brake after introduction of an obstacle

  7. Collisions

    Time frame: baseline

    number of times the car hit an obstacle

  8. Collisions

    Time frame: 15 minutes post smoking

    number of times the car hit an obstacle

  9. Collisions

    Time frame: 180 minutes post smoking

    number of times the car hit an obstacle

  10. Concentration of THC (ng/ml)

    Time frame: Baseline

    Psychoactive component of cannabis

  11. Concentration of THC (ng/ml)

    Time frame: 15 minutes post smoking

    Psychoactive component of cannabis

  12. Useful Field of View Processing Speed

    Time frame: baseline

    Mean threshold for discriminating stimuli presented in central vision

  13. Useful Field of View Processing Speed

    Time frame: 60 minutes post smoking

    Mean threshold for discriminating stimuli presented in central vision

  14. Useful Field of View Processing Speed

    Time frame: 210 minutes post smoking

    Mean threshold for discriminating stimuli presented in central vision

  15. Useful Field of View Divided attention

    Time frame: baseline

    Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task

  16. Useful Field of View Divided attention

    Time frame: 60 minutes

    Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task

  17. Useful Field of View Divided attention

    Time frame: 210 minutes

    Mean threshold for discriminating stimuli presented in central vision, with a concurrent perpheral target task

  18. Useful Field of View Selective attention

    Time frame: baseline

    Mean threshold for divided attention but with distractors

  19. Useful Field of View Selective attention

    Time frame: 60 minutes

    Mean threshold for divided attention but with distractors

  20. Useful Field of View Selective attention

    Time frame: 210 minutes

    Mean threshold for divided attention but with distractors

  21. Trail making task

    Time frame: baseline

    Cognitive assessment

  22. Trail making task

    Time frame: 60 minutes post smoking

    Cognitive assessment

  23. Trail making task

    Time frame: 210 minutes post smoking

    Cognitive assessment

  24. Verbal free recall

    Time frame: baseline

    Test of memory

  25. Verbal free recall

    Time frame: 60 minutes post smoking

    Test of memory

  26. Verbal free recall

    Time frame: 210 minutes post smoking

    Test of memory

  27. Addiction Research Centre Inventory

    Time frame: baseline

    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

  28. Addiction Research Centre Inventory

    Time frame: 60 minutes post smoking

    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

  29. Addiction Research Centre Inventory

    Time frame: 210 minutes post smoking

    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

  30. Profile of Mood States

    Time frame: baseline

    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

  31. Profile of Mood States

    Time frame: 60 minutes post smoking

    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

  32. Profile of Mood States

    Time frame: 210 minutes post smoking

    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

  33. Visual Analog Scale

    Time frame: baseline

    test of mood on a scale from 0 to 100, with greater number indicating more agreement

  34. Visual Analog Scale

    Time frame: 15 minutes post smoking

    test of mood on a scale from 0 to 100, with greater number indicating more agreement

  35. Visual Analog Scale

    Time frame: 60 minutes post smoking

    test of mood on a scale from 0 to 100, with greater number indicating more agreement

  36. Visual Analog Scale

    Time frame: 120 minutes post smoking

    test of mood on a scale from 0 to 100, with greater number indicating more agreement

  37. Visual Analog Scale

    Time frame: 180 minutes post smoking

    test of mood on a scale from 0 to 100, with greater number indicating more agreement

  38. Visual Analog Scale

    Time frame: 240 minutes post smoking

    test of mood on a scale from 0 to 100, with greater number indicating more agreement

  39. Visual Analog Scale

    Time frame: 300 minutes post smoking

    test of mood on a scale from 0 to 100, with greater number indicating more agreement

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Di Ciano

CONTACT

[email protected]

416-535-8501 ext. 34002

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Acronym: CASE-CT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2022
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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