Recruiting
Phase 2

Cannabis

Sponsor:

Prairie Plant Systems Inc.

Code:

NCT02324777

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Cannabis

Volcano® Medic Vapourizer

Study Details

Brief 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.

Conditions

Osteoarthritis, Knee

Study ID

NCT02324777

Start date

Jun, 2015

Status verified date

Apr, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Idiopathic (primary) OA of the knee as defined by American College of Rheumatology criteria
2. Age ≥50 years
3. Numerical Rating Scale (NRS) Pain intensity score ≥ 4 (on a 0-10 scale)
4. Stable medication and treatment regimen
5. Open to Canadian Residents only

Exclusion Criteria:

1. Pregnant/nursing
2. BMI >39kg/m2
3. Secondary causes of OA
4. Stage IV OA of the knee
5. Significant other cause of pain (e.g. fibromyalgia, CRPS)
6. Significant cardiac, neurological, psychiatric or respiratory disease
7. Joint infiltration in 30 days prior to trial or during study
8. Positive urine screen for THC

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CanniMed™ DPF-I Volcano® Vapourization

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.

experimental: CanniMed™ DPF-II Volcano® Vapourization

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.

experimental: CanniMed™ DPF-III Volcano® Vapourization

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.

experimental: CanniMed™ DPF-IV Volcano® Vapourization

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.

experimental: CanniMed™ DPF-V Volcano® Vapourization

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.

placebo comparator: CanniMed™ DPF-P Volcano® Vapourization

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.

Interventions

Cannabis

Cannabis sativa L. subsp. indica, variety indica blends of flowering heads that have been air-dried, milled, destemmed and fine ground, stored in glass vials with aluminum caps in 100 mg dose size.

Volcano® Medic Vapourizer

Volcano® Medic vapourizer is licensed for medical administration of cannabis in Canada March 2010 (Licence No. 82405).

The contents of a vial of drug product formulation will be transferred to the Volcano® Medic's filling chamber (sample-holder) equipped top and bottom with fine wire mesh to retain the finely ground material. The filling chamber will be placed atop the main body of the unit and then have a, 12.5 L, heat-resistant Medic Valve balloon affixed. Active components are vapourized at 190 °C. The ensuing vapour is captured in the balloon and inhaled by the study subject using a standardized inhalation technique.

Primary outcome measure

  • Total pain reduction of vapourized cannabinoids with varying degrees of THC/CBD ratios in patients with painful OA of the knee. [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes post-dose ]

Central Contacts and Locations

Central contacts

Locations

Pain Management Unit, Queen Elizabeth II Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 1V7

Contacts

Principal Investigator:

Mary Lynch, MD

Montreal General Hospital - McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

More Information

Sponsor

Prairie Plant Systems Inc.

Last update posted

Apr 5, 2018

Last verified

Apr, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Prairie Plant Systems Inc. on 2018-04-05.