Status:
RECRUITING
Modulation of THC Effects by CBD: a Dose-ranging Study
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Cannabis
THC
Eligibility:
All Genders
21-49 years
Phase:
PHASE1
PHASE2
Brief Summary
The purposes of this study are 1) to determine if CBD modulates THC-induced acute psychoactive effects at different CBD:THC ratios, compared with the control product (0:20, 20:20, 40:20, 80:20, 120:20...
Detailed Description
Despite more than 40 years of research on the active compounds present in the cannabis plant, the influence of CBD consumption on the metabolism, pharmacology, and behavioral effects of THC remains fr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Between 21 and 49 years of age, inclusively;
- Have used cannabis at least once in their lifetime and have used cannabis three days or less in the 30 days prior to enrollment;
- Be able to provide a signed informed consent;
- Willing to comply with study procedures and requirements as per protocol;
- Have a forced expiratory volume in first second (FEV) less than or equal to 90 %;
- Able to communicate and understand English or French language;
- 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
- Participants will be excluded if any of the following criteria are met:
- 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;
- 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);
- 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;
- Known chronic liver disease or aspartate transaminase/alanine transaminase (AST/ALT) two times higher than upper limit of normal values at screening visit;
- Blood pressure higher than 130/80 mmHg;
- Kidney disorders;
- Bleeding disorders;
- Current moderate or severe DSM-5 substance use disorder (except nicotine) according to SCID-V;
- Currently pregnant, breastfeeding or planning to become pregnant either at screening or while enrolled in the study;
- Pending legal action or other reason that, in the opinion of the study physician, might prevent study completion;
- Use of medication within 7 days of experimental sessions; which, in the opinion of the Investigator, may interact with cannabis.
- Participation in clinical studies or undergoing other investigational procedure involving cannabis or cannabinoids administration within 30 days prior to randomization.
- Resting heart rate over 100 beats per minute.
- Current body mass index (BMI) over 29.9 kg/m2.
- Any clinically significant electrocardiogram abnormalities at screening visit.
Exclusion
Key Trial Info
Start Date :
June 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06099379
Start Date
June 27 2024
End Date
December 31 2026
Last Update
December 22 2025
Active Locations (1)
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1
Centre de recherche du Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, Canada, H2X0A9