Status:
NOT_YET_RECRUITING
A Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Cannabis
Eligibility:
All Genders
21-49 years
Phase:
PHASE1
PHASE2
Brief Summary
The purposes of this study are 1) to determine if the administration of different low doses of CBD (5 mg, 20 mg, 50 mg and 100 mg) result in detectable subjective pleasant drug effect compared to plac...
Detailed Description
Cannabis contains over 100 cannabinoids, the two most prominent being Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). A growing body of evidence exists surrounding the effects of both THC and CB...
Eligibility Criteria
Inclusion
- Between 21 and 49 years of age, inclusively;
- Have used cannabis at least once in lifetime AND have used cannabis three days or less in the 28 days prior to enrollment;
- Be able to provide a signed informed consent;
- Willing to comply with study procedures and requirements as per protocol, including to abstain from using other cannabis products or any drugs (except alcohol or nicotine) 7 days prior to study visits;
- Have a forced expiratory volume in first second (FEV) sup 90 %;
- Able to communicate and understand English or French language;
- For female participants:
- a. Without 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. With childbearing potential: i. Must have negative pregnancy test result at screening and at subsequent visits.
- ii. AND have no pregnancy plan while on the trial iii. AND must agree to use a medically accepted method of birth control throughout the study.
Exclusion
- Any disabling medical conditions, 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 (e.g. history of schizophrenia, schizoaffective disorder or bipolar disorder; current acute psychosis, mania or current suicidality, acute depression or anxiety disorder 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 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 (The Diagnostic and Statistical Manual of Mental Disorders) substance use disorder (except nicotine) according to the Structured Clinical Interview for DSM-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 procedures 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.
Key Trial Info
Start Date :
September 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05320367
Start Date
September 1 2026
End Date
December 1 2027
Last Update
December 22 2025
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