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Trial record 41 of 154 for:    cannabis | Recruiting, Enrolling by invitation Studies

Cannabinoid Profile Investigation of Vapourized Cannabis in Patients With Osteoarthritis of the Knee (CAPRI)

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ClinicalTrials.gov Identifier: NCT02324777
Recruitment Status : Recruiting
First Posted : December 24, 2014
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
McGill University Health Center
Dalhousie University
Algorithme Pharma Inc
Research Institute of the McGill University Health Center
Information provided by (Responsible Party):
Prairie Plant Systems Inc.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Cannabis Device: Volcano® Medic Vapourizer Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Placebo Controlled, Proof-of-concept, Crossover Clinical Trial of Vapourized Cannabis in Adults With Painful Osteoarthritis of the Knee
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: 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.
Other Names:
  • Marijuana
  • Marihuana
  • CanniMed™

Device: 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.


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.
Drug: 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.
Other Names:
  • Marijuana
  • Marihuana
  • CanniMed™

Device: 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.


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.
Drug: 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.
Other Names:
  • Marijuana
  • Marihuana
  • CanniMed™

Device: 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.


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.
Drug: 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.
Other Names:
  • Marijuana
  • Marihuana
  • CanniMed™

Device: 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.


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.
Drug: 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.
Other Names:
  • Marijuana
  • Marihuana
  • CanniMed™

Device: 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.


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.
Drug: 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.
Other Names:
  • Marijuana
  • Marihuana
  • CanniMed™

Device: 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 Measures :
  1. 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 ]
    The main efficacy endpoint is pain reduction, calculated as a change in pain intensity (VAS pain intensity) following each exposure. A Total Pain Reduction (TOTPAR) score is calculated from repeated VAS pain scores taken immediately before (baseline) and every 15 minutes after exposure for the first hour then half-hourly for the remaining two hours after treatment exposure (treatment). The treatment VAS pain intensity scores are then subtracted from the baseline VAS pain intensity to generate a pain relief score for each time point. The sum of pain relief scores from each time point is used to generate a 3-hour Total Pain Reduction (TOTPAR-3) score for each exposure.


Secondary Outcome Measures :
  1. Pain, stiffness, physical, social and emotional functional outcomes of vapourized cannabis with varying degrees of THC/CBD ratios in patients with painful OA of the knee. [ Time Frame: Up to 6 weeks ]

    Pain and functional outcomes will be measured using the Western Ontario and McMaster Osteoarthritis Index (WOMAC).

    The WOMAC Osteoarthritis Index is a 24-item instrument that assesses the three dimensions of pain, disability and joint stiffness in studies of knee and hip osteoarthritis. The WOMAC Osteoarthritis Index will be completed by the subject at Visit 2-8.


  2. Pharmacokinetics profile of 7 plasma cannabinoid metabolites from vapourized cannabis of differing cannabinoid profiles in patients with OA. [ Time Frame: 0, 15, 30, 60, 120 and 180 minutes post-dose ]

    Pharmacokinetic analysis encompasses an assay validated for: Δ9-tetrahydrocannabinol (THC); 11-nor-Δ9-tetrahydrocannabinol-9-carboxylic acid (11-nor-Δ9-THC-9-COOH); 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC); cannabinol (CBN); cannabidiol (CBD); and qualified for: Δ9-tetrahydrocannabinolic acid (THCA); cannabidiolic acid (CBDA).

    Blood will be taken prior to inhalation (T = 0) and at 2, 30, 60, and 180 minutes after each exposure for pharmacokinetic assessments of plasma cannabinoid levels. These intervals have been used to evaluate PK of vapourized cannabis in healthy volunteers (Abrams, et al., 2007).


  3. Changes in blood pressure from baseline [ Time Frame: Up to 7 weeks ]
    Resting/sitting and postural change in blood pressure are assessed at screening and at each subsequent clinical visit where the interventions are used to gauge changes and acute or sustained changes during the course of treatment. Sitting and postural change in BP are taken at 0, 30, 60, 90, 120, 150, and 180 minutes post-dose.

  4. Changes in heart rate (HR) from baseline [ Time Frame: Up to 7 weeks ]
    Sitting heart rates are assessed at screening and at each subsequent clinical visit where the interventions are used to gauge changes and acute or sustained changes during the course of treatment. Sitting HR is taken at 0, 30, 60, 90, 120, 150, and 180 minutes post-dose.

  5. Blood chemistry - liver function [ Time Frame: Up to 7 weeks ]
    Blood is taken at screening, and then for each clinical visit where the interventions are used at T = 0 (prior to inhalation) and at T = 180 minutes (end of study visit) for aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT). Inclusion criteria for candidates is AST < 3X normal (normal = 5 - 40 units per litre of serum). Change from baseline at screening and per visit with intervention will be assessed for short term liver changes following a single exposure to differing levels of inhaled THC and/or CBD.

  6. Blood chemistry - renal function [ Time Frame: Up to 7 weeks ]
    Blood is taken at screening, and then for each clinical visit where the interventions are used at T = 0 (prior to inhalation) and at T = 180 minutes (end of study visit) for serum creatinine. Inclusion criteria for candidates is serum creatinine < 133 μmol/. Change from baseline at screening and per visit with intervention will be assessed for short term renal changes following a single exposure to differing levels of inhaled THC and/or CBD.

  7. Hematology - hematocrit level (complete blood count) [ Time Frame: Up to 7 weeks ]
    Blood is taken at screening, and then for each clinical visit where the interventions are used at T = 0 (prior to inhalation) and at T = 180 minutes (end of study visit) for hematocrit level (or CBC). Inclusion criteria for candidates is CBC > 35%. Change from baseline at screening and per visit with intervention will be assessed for short term hematological changes following a single exposure to differing levels of inhaled THC and/or CBD.

  8. Cannabinoid urine analysis at screening and for washout confirmation [ Time Frame: Up to 7 weeks ]
    Urine analysis (THC = 50 mg/mL) will be performed at each clinical visit to gauge cannabinoid clearance prior to the interventions and to ensure that washout between interventions is maintained as each dose should not produce a sustained 1 week urine result.

  9. Psychoactive adverse events [ Time Frame: Up to 6 weeks ]
    A Psychoactive Adverse Event checklist will be administered by the Research Nurse to the participant to report on any changes in their emotional state (such as anxiety, panic, paranoia, depersonalization, mood alteration and altered perceptions etc) every 15 minutes after exposure for the first hour then half-hourly for the remaining two hours.

  10. Patient global rating of preference for each cannabis preparation. [ Time Frame: Up to 6 weeks ]
    Patient global rating of preference for each cannabis preparation will be measured using a VAS (drug liking 0: Do not like at all; 100: really like a lot) after each exposure, and a global ranking after all six exposures have been completed.

  11. Visual Analog Scale (VAS) feelings of drug effect [ Time Frame: Up to 6 weeks ]

    The VAS for feelings of drug effect is a horizontal line measurement of 100mm with Anchors of 0 = not high at all and 100 = most high ever. Subjects mark their Feeling of Drug Effect by placing a vertical line through the horizontal line to indicate how "high" they are feeling NOW.

    The VAS for Feelings of Drug Effect will be completed by the subject at each intervention visit; taken at 15 minute intervals after exposure for the first hour then half-hourly for the remaining two hours.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324777


Contacts
Contact: Angela D Perry, MSc 306-975-1207 ext 1283 adp@prairieplant.com
Contact: Larry A Hollbrook, PhD 306-975-1207 ext 1243 lah@prairieplant.com

Locations
Canada, Nova Scotia
Pain Management Unit, Queen Elizabeth II Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Melissa Todd    (902) 473-7475    melissa.todd@nshealth.ca   
Principal Investigator: Mary Lynch, MD         
Canada, Quebec
Montreal General Hospital - McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Mark Ware, MRCP(UK)    514 934-1934 ext 42784    mark.ware@mcgill.ca   
Sponsors and Collaborators
Prairie Plant Systems Inc.
McGill University Health Center
Dalhousie University
Algorithme Pharma Inc
Research Institute of the McGill University Health Center
Investigators
Principal Investigator: Mark Ware, MD McGill University Health Center
Principal Investigator: Mary Lynch, MD Queen Elizabeth II Health Science Centre

Additional Information:
Publications:
Responsible Party: Prairie Plant Systems Inc.
ClinicalTrials.gov Identifier: NCT02324777     History of Changes
Other Study ID Numbers: PPS001
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases