Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2024-06-27
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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CBD:THC Group 1
Group will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 mg).
Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit.
The order in which the study products will be administered depend on the randomization sequence.
∆9-tetrahydrocannabinol
Phytocannabinoids from plant inflorescences (CBD and THC dominant) - inhaled
CBD:THC Group 2
Group will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 mg).
Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit.
The order in which the study products will be administered depend on the randomization sequence.
∆9-tetrahydrocannabinol
Phytocannabinoids from plant inflorescences (CBD and THC dominant) - inhaled
CBD:THC Group 3
Group will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 mg).
Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit.
The order in which the study products will be administered depend on the randomization sequence.
∆9-tetrahydrocannabinol
Phytocannabinoids from plant inflorescences (CBD and THC dominant) - inhaled
CBD:THC Group 4
Group will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 mg).
Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit.
The order in which the study products will be administered depend on the randomization sequence.
∆9-tetrahydrocannabinol
Phytocannabinoids from plant inflorescences (CBD and THC dominant) - inhaled
CBD:THC Group 5
Group will receive four doses of CBD:THC ratio (20:20 mg, 40:20 mg, 80:20 mg and 120:20 mg) and a control product CBD:THC ratio (0:20 mg).
Group will attend a total of five study visits (one for each study product) with at least 1 week between each visit.
The order in which the study products will be administered depend on the randomization sequence.
∆9-tetrahydrocannabinol
Phytocannabinoids from plant inflorescences (CBD and THC dominant) - inhaled
Interventions
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∆9-tetrahydrocannabinol
Phytocannabinoids from plant inflorescences (CBD and THC dominant) - inhaled
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have used cannabis at least once in their lifetime and have used cannabis three days or less in the 30 days prior to enrollment;
3. Be able to provide a signed informed consent;
4. Willing to comply with study procedures and requirements as per protocol;
5. Have a forced expiratory volume in first second (FEV) less than or equal to 90 %;
6. Able to communicate and understand English or French language;
7. For female participants:
a. No childbearing potential, defined as: i. postmenopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age); or ii. Documented surgically sterilized (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or b. For female of childbearing potential: i. Must have negative pregnancy test result at screening and at subsequent visits.
ii. AND have no pregnancy plan while on the study iii. AND must agree to use a medically accepted method of birth control throughout the study.
Exclusion Criteria
1. Any disabling medical condition, as assessed by medical history, physical exam, vital signs and/or laboratory assessments that, in the opinion of the study physician, precludes safe participation in the study or the ability to provide fully informed consent;
2. Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or current suicidality based on the Mini International Neuropsychiatric Interview);
3. Any other disabling, unstable or acute mental condition that, in the opinion of the study physician, precludes safe participation in the study or ability to provide fully informed consent;
4. Known chronic liver disease or aspartate transaminase/alanine transaminase (AST/ALT) two times higher than upper limit of normal values at screening visit;
5. Blood pressure higher than 130/80 mmHg;
6. Kidney disorders;
7. Bleeding disorders;
8. Current moderate or severe DSM-5 substance use disorder (except nicotine) according to SCID-V;
9. Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolled in the study;
10. Pending legal action or other reason that, in the opinion of the study physician, might prevent study completion;
11. Use of medication within 7 days of experimental sessions; which, in the opinion of the Investigator, may interact with cannabis.
12. Participation in clinical studies or undergoing other investigational procedure involving cannabis or cannabinoids administration within 30 days prior to randomization.
13. Resting heart rate over 100 beats per minute.
14. Current body mass index (BMI) over 29.9 kg/m2.
15. Any clinically significant electrocardiogram abnormalities at screening visit.
21 Years
49 Years
ALL
Yes
Sponsors
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Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Principal Investigators
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Didier Jutras-Aswad, MD, MS
Role: PRINCIPAL_INVESTIGATOR
CRCHUM
Locations
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Centre de recherche du Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Pamela Lachance-Touchette, Ph.D
Role: primary
Amina Sow, Ph.D
Role: backup
Other Identifiers
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2024-11772
Identifier Type: -
Identifier Source: org_study_id