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Cannabinoid
CanniMed™ DPF-III Volcano® Vapourization for Osteoarthritis (CAPRI Trial)
Phase 2
Waitlist Available
Led By Mark Ware, MD
Research Sponsored by Prairie Plant Systems Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes post-dose
Awards & highlights
CAPRI Trial Summary
Primary Objective: - To determine the analgesic dose-response characteristics of vapourized cannabinoids with varying degrees of delta-9-tetrahydrocannabiol (THC)/ Cannabidiol (CBD) ratios. Secondary Objectives: To compare functional changes and patient preferences of different cannabinoid (THC, CBD) profiles in patients with OA (Osteoarthritis); To describe the Pharmacokinetics (PK) of vapourized cannabis of differing cannabinoid profiles in patients with OA; To explore the short term safety of vapourized cannabis with different cannabinoid profiles. To describe the incidence and severity of psychoactive events.
Eligible Conditions
- Osteoarthritis
CAPRI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 15, 30, 45, 60, 90, 120, 150, 180 minutes post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total pain reduction of vapourized cannabinoids with varying degrees of THC/CBD ratios in patients with painful OA of the knee.
Secondary outcome measures
Blood chemistry - liver function
Blood chemistry - renal function
Cannabinoid urine analysis at screening and for washout confirmation
+8 moreCAPRI Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: CanniMed™ DPF-V Volcano® VapourizationExperimental Treatment2 Interventions
Using the Volcano® Medic, a dose of 100 mg of finely ground herbal cannabis drug product formulation with a potency specification similar to CanniMed™ 1·13 product profile of 0.6% w/w total THC and 13.0% w/w total CBD is vapourized and inhaled by study subjects.
Group II: CanniMed™ DPF-IV Volcano® VapourizationExperimental Treatment2 Interventions
Using the Volcano® Medic, a dose of 100 mg of finely ground herbal cannabis drug product formulation with a potency specification similar to CanniMed™ 4·10 product, of 3.8% w/w total THC and 10.0% w/w total CBD is vapourized and inhaled by study subjects.
Group III: CanniMed™ DPF-III Volcano® VapourizationExperimental Treatment2 Interventions
Using the Volcano® Medic, a dose of 100 mg of finely ground herbal cannabis drug product formulation with a potency specification the same as CanniMed™ 9·9 product, of 9.0% w/w total THC and 9.5% w/w total CBD is vapourized and inhaled by study subjects.
Group IV: CanniMed™ DPF-II Volcano® VapourizationExperimental Treatment2 Interventions
Using the Volcano® Medic, a dose of 100 mg of finely ground herbal cannabis drug product formulation with a potency specification the same as the CanniMed™ 15·5 product, of 15.0% w/w total THC and 5.0% w/w total CBD is vapourized and inhaled by study subjects.
Group V: CanniMed™ DPF-I Volcano® VapourizationExperimental Treatment2 Interventions
Using the Volcano® Medic, a dose of 100 mg of finely ground herbal cannabis drug product formulation (DPF) with a potency specification similar to CanniMed™ 22·1 product, of 21.9% w/w total THC and 0.8% w/w total CBD is vapourized and inhaled by study subjects.
Group VI: CanniMed™ DPF-P Volcano® VapourizationPlacebo Group2 Interventions
Using the Volcano® Medic, a dose of 100 mg of ethanol extracted DPF-V, reducing the potency profile to <0.3% w/w total THC and <0.3% w/w total CBD (comparable to the threshold levels described for "industrial hemp", as per the Canadian Industrial Hemp Regulations (SOR/98-156), is vapourized and inhaled by study subjects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Cannabis
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Prairie Plant Systems Inc.Lead Sponsor
Research Institute of the McGill University Health CenterUNKNOWN
2 Previous Clinical Trials
4,975 Total Patients Enrolled
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
442 Previous Clinical Trials
159,134 Total Patients Enrolled
3 Trials studying Osteoarthritis
88 Patients Enrolled for Osteoarthritis
Frequently Asked Questions
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