Osteoarthritis, KneePhase 2CAPRINCT02324777
Cannabinoid Profile Investigation of Vapourized Cannabis in Patients With Osteoarthritis of the Knee
A Phase 2 study testing Cannabis and Volcano® Medic Vapourizer in people with Osteoarthritis, Knee, run by Prairie Plant Systems Inc. at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Cannabis and Volcano® Medic Vapourizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2015to Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic (primary) OA of the knee as defined by American College of Rheumatology criteria
- Age ≥50 years
- Numerical Rating Scale (NRS) Pain intensity score ≥ 4 (on a 0-10 scale)
- Stable medication and treatment regimen
- Open to Canadian Residents only
Who cannot join
- Pregnant/nursing
- BMI >39kg/m2
- Secondary causes of OA
- Stage IV OA of the knee
- Significant other cause of pain (e.g. fibromyalgia, CRPS)
- Significant cardiac, neurological, psychiatric or respiratory disease
- Joint infiltration in 30 days prior to trial or during study
- Positive urine screen for THC
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Pain Management Unit, Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
Melissa Todd, (902) 473-7475, melissa.todd@nshealth.ca
Mary Lynch, MD
- Recruiting
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, H3G 1A4
Mark Ware, MRCP(UK), 514 934-1934 ext. 42784, mark.ware@mcgill.ca
About this study
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
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.
Read the detailed description
A Phase IIa randomized double blind placebo controlled crossover trial (RCT) using six different herbal cannabis drug product formulations prepared by the Sponsor, Prairie Plant Systems Inc. An initial screening period (minimum one week) will be completed for pain assessment and determination of eligibility. After screening, eligible subjects will be randomly assigned to receive all 6 different formulations in a random order.
The study will be conducted using six periods of 7 days duration, with each period consisting of one day of exposure and 6 days of washout from study drug. The study will therefore take 6 weeks to be completed for each enrolled subject with an additional week for adverse event monitoring after the final study exposure. Total time in study may therefore be a maximum of nine weeks (including screening).
Adult subjects (age ≥50y) will be recruited with chronic (>3 months) moderate to severe pain (pain score ≥40/100 on visual analogue scale) due to primary osteoarthritis (OA) of the knee as defined by American College of Rheumatology (ACR) criteria. Target enrolment for this study is 36 (18 from each site).
The study will be conducted at the Alan Edwards Pain Management Unit of the McGill University Health Centre, in Montreal, Quebec, Canada and the Pain Management Unit at the Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia, Canada. A dedicated ventilated room is available at these sites for cannabinoid inhalation studies as used in prior evaluation trials on medicinal cannabis.
All subjects meeting eligibility criteria after the screening period will be randomized to receive all 6 herbal cannabis drug product formulations in a randomly assigned order of treatment between Clinical Visit (CV) 2 and CV7.
A washout period of 6 days is proposed between the six different treatment periods. This will allow the pharmacological effects of each dose to be minimized prior to each subsequent dosing period to avoid confounding.
Throughout the study all subjects will remain on their stable (pharmacological and non-pharmacological) treatment regimen.
Throughout the study, subjects will be blinded to the treatment they are receiving. Once a subject has been randomized, the investigator and the subject, as well as all staff involved in the conduct or management of the study will be blinded to the treatment assignment. All dosing will be via the Volcano® Medic vapourizer (licensed for medical administration of cannabis in Canada March 2010; Licence No. 82405) and both the nurse and the patient will be familiarized with its instruction manual.
The study nurse will prepare the dose for the subject. After opening the vial of drug product formulation, its contents 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 to it (this balloon will be housed within an opaque bag that is required to ensure blinding because the placebo generates little in the way of visible vapour). Active components (THCA and CBDA decarboxylated to THC and CBD) will be vapourized out of the herbal material by a stream of hot air with an exact, predefined temperature (190 °C). The ensuing vapour will be captured in the balloon. After filling has been completed (35 seconds), a mouthpiece will be attached to the balloon for inhalation of the vapour by the study subject. The total contents of the balloon will be inhaled over five minutes by using a standardized inhalation technique. Immediately after the bag has been removed from the Volcano® Medic, inhalation will be according to the following regimen:
- Inhale for 4 seconds
- Hold breath for 6 seconds
- Exhale and breathe normally for 20 seconds
- Repeat this inhale-hold-breathe cycle (30 seconds) until the bag has been evacuated.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Cannabis, Volcano® Medic Vapourizer
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Also called Marijuana, Marihuana, CanniMed™
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 VapourizerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CanniMed™ DPF-I Volcano® Vapourization | Experimental | 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. Receives: Drug: Cannabis; Device: Volcano® Medic Vapourizer |
| CanniMed™ DPF-II Volcano® Vapourization | Experimental | 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. Receives: Drug: Cannabis; Device: Volcano® Medic Vapourizer |
| CanniMed™ DPF-III Volcano® Vapourization | Experimental | 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. Receives: Drug: Cannabis; Device: Volcano® Medic Vapourizer |
| CanniMed™ DPF-IV Volcano® Vapourization | Experimental | 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. Receives: Drug: Cannabis; Device: Volcano® Medic Vapourizer |
| CanniMed™ DPF-V Volcano® Vapourization | Experimental | 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. Receives: Drug: Cannabis; Device: Volcano® Medic Vapourizer |
| CanniMed™ DPF-P Volcano® Vapourization | Placebo comparator | 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. Receives: Drug: Cannabis; Device: Volcano® Medic Vapourizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pain reduction of vapourized cannabinoids with varying degrees of THC/CBD ratios in patients with painful OA of the knee.
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.
Measured: 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes post-dose
Secondary outcomes (11)
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.
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.
Measured: Up to 6 weeks
Pharmacokinetics profile of 7 plasma cannabinoid metabolites from vapourized cannabis of differing cannabinoid profiles in patients with OA.
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).
Measured: 0, 15, 30, 60, 120 and 180 minutes post-dose
Changes in blood pressure from baseline
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.
Measured: Up to 7 weeks
Changes in heart rate (HR) from baseline
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.
Measured: Up to 7 weeks
Blood chemistry - liver function
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.
Measured: Up to 7 weeks
Blood chemistry - renal function
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.
Measured: Up to 7 weeks
Hematology - hematocrit level (complete blood count)
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.
Measured: Up to 7 weeks
Cannabinoid urine analysis at screening and for washout confirmation
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.
Measured: Up to 7 weeks
Psychoactive adverse events
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.
Measured: Up to 6 weeks
Patient global rating of preference for each cannabis preparation.
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.
Measured: Up to 6 weeks
Visual Analog Scale (VAS) feelings of drug effect
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.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJun 2015
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prairie Plant Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Dalhousie University, Algorithme Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Mark Ware, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreMary Lynch, MD, Principal investigator, Queen Elizabeth II Health Science Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324777
- Sponsor's protocol ID
- PPS001
- Acronym
- CAPRI
- Status last verified
- Apr 2018
- First submitted
- 5 Dec 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abrams DI, Vizoso HP, Shade SB, Jay C, Kelly ME, Benowitz NL. Vaporization as a smokeless cannabis delivery system: a pilot study. Clin Pharmacol Ther. 2007 Nov;82(5):572-8. doi: 10.1038/sj.clpt.6100200. Epub 2007 Apr 11.
PubMed 17429350
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02324777
- Acronym / sponsor ID
- CAPRI / PPS001
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Prairie Plant Systems Inc.Industry (pharma, biotech, devices)
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Dalhousie University, Algorithme Pharma Inc
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A Phase IIa randomized double blind placebo controlled crossover trial (RCT) using six different herbal cannabis drug product formulations prepared by the Sponsor, Prairie Plant Systems Inc. An initial screening period (minimum one week) will be completed for pain assessment and determination of eligibility. After screening, eligible subjects will be randomly assigned to receive all 6 different formulations in a random order.
The study will be conducted using six periods of 7 days duration, with each period consisting of one day of exposure and 6 days of washout from study drug. The study will therefore take 6 weeks to be completed for each enrolled subject with an additional week for adverse event monitoring after the final study exposure. Total time in study may therefore be a maximum of nine weeks (including screening).
Adult subjects (age ≥50y) will be recruited with chronic (>3 months) moderate to severe pain (pain score ≥40/100 on visual analogue scale) due to primary osteoarthritis (OA) of the knee as defined by American College of Rheumatology (ACR) criteria. Target enrolment for this study is 36 (18 from each site).
The study will be conducted at the Alan Edwards Pain Management Unit of the McGill University Health Centre, in Montreal, Quebec, Canada and the Pain Management Unit at the Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia, Canada. A dedicated ventilated room is available at these sites for cannabinoid inhalation studies as used in prior evaluation trials on medicinal cannabis.
All subjects meeting eligibility criteria after the screening period will be randomized to receive all 6 herbal cannabis drug product formulations in a randomly assigned order of treatment between Clinical Visit (CV) 2 and CV7.
A washout period of 6 days is proposed between the six different treatment periods. This will allow the pharmacological effects of each dose to be minimized prior to each subsequent dosing period to avoid confounding.
Throughout the study all subjects will remain on their stable (pharmacological and non-pharmacological) treatment regimen.
Throughout the study, subjects will be blinded to the treatment they are receiving. Once a subject has been randomized, the investigator and the subject, as well as all staff involved in the conduct or management of the study will be blinded to the treatment assignment. All dosing will be via the Volcano® Medic vapourizer (licensed for medical administration of cannabis in Canada March 2010; Licence No. 82405) and both the nurse and the patient will be familiarized with its instruction manual.
The study nurse will prepare the dose for the subject. After opening the vial of drug product formulation, its contents 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 to it (this balloon will be housed within an opaque bag that is required to ensure blinding because the placebo generates little in the way of visible vapour). Active components (THCA and CBDA decarboxylated to THC and CBD) will be vapourized out of the herbal material by a stream of hot air with an exact, predefined temperature (190 °C). The ensuing vapour will be captured in the balloon. After filling has been completed (35 seconds), a mouthpiece will be attached to the balloon for inhalation of the vapour by the study subject. The total contents of the balloon will be inhaled over five minutes by using a standardized inhalation technique. Immediately after the bag has been removed from the Volcano® Medic, inhalation will be according to the following regimen:
- Inhale for 4 seconds
- Hold breath for 6 seconds
- Exhale and breathe normally for 20 seconds
- Repeat this inhale-hold-breathe cycle (30 seconds) until the bag has been evacuated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CanniMed™ DPF-I Volcano® Vapourization | Experimental | Drug: Cannabis, Device: Volcano® Medic VapourizerUsing 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. |
| CanniMed™ DPF-II Volcano® Vapourization | Experimental | Drug: Cannabis, Device: Volcano® Medic VapourizerUsing 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. |
| CanniMed™ DPF-III Volcano® Vapourization | Experimental | Drug: Cannabis, Device: Volcano® Medic VapourizerUsing 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. |
| CanniMed™ DPF-IV Volcano® Vapourization | Experimental | Drug: Cannabis, Device: Volcano® Medic VapourizerUsing 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. |
| CanniMed™ DPF-V Volcano® Vapourization | Experimental | Drug: Cannabis, Device: Volcano® Medic VapourizerUsing 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. |
| CanniMed™ DPF-P Volcano® Vapourization | Placebo comparator | Drug: Cannabis, Device: Volcano® Medic VapourizerUsing 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Idiopathic (primary) OA of the knee as defined by American College of Rheumatology criteria
- Age ≥50 years
- Numerical Rating Scale (NRS) Pain intensity score ≥ 4 (on a 0-10 scale)
- Stable medication and treatment regimen
- Open to Canadian Residents only
Key exclusion criteria (8 listed)
- Pregnant/nursing
- BMI >39kg/m2
- Secondary causes of OA
- Stage IV OA of the knee
- Significant other cause of pain (e.g. fibromyalgia, CRPS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabisAlso: Marijuana, Marihuana, CanniMed™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. | Drug | CanniMed™ DPF-I Volcano® Vapourization, CanniMed™ DPF-II Volcano® Vapourization, CanniMed™ DPF-III Volcano® Vapourization, CanniMed™ DPF-IV Volcano® Vapourization, CanniMed™ DPF-P Volcano® Vapourization, CanniMed™ DPF-V Volcano® Vapourization |
| Volcano® Medic VapourizerVolcano® 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. | Device | CanniMed™ DPF-I Volcano® Vapourization, CanniMed™ DPF-II Volcano® Vapourization, CanniMed™ DPF-III Volcano® Vapourization, CanniMed™ DPF-IV Volcano® Vapourization, CanniMed™ DPF-P Volcano® Vapourization, CanniMed™ DPF-V Volcano® Vapourization |
Primary outcome
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.
11 secondary outcomes
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
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
Changes in blood pressure from baseline
Time frame: Up to 7 weeks
Changes in heart rate (HR) from baseline
Time frame: Up to 7 weeks
Blood chemistry - liver function
Time frame: Up to 7 weeks
Blood chemistry - renal function
Time frame: Up to 7 weeks
Hematology - hematocrit level (complete blood count)
Time frame: Up to 7 weeks
Cannabinoid urine analysis at screening and for washout confirmation
Time frame: Up to 7 weeks
Psychoactive adverse events
Time frame: Up to 6 weeks
Patient global rating of preference for each cannabis preparation.
Time frame: Up to 6 weeks
Visual Analog Scale (VAS) feelings of drug effect
Time frame: Up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 17429350Abrams DI, Vizoso HP, Shade SB, Jay C, Kelly ME, Benowitz NL. Vaporization as a smokeless cannabis delivery system: a pilot study. Clin Pharmacol Ther. 2007 Nov;82(5):572-8. doi: 10.1038/sj.clpt.6100200. Epub 2007 Apr 11.
- WOMAC Osteoarthritis IndexLink provided by the sponsor.
- CanniMed Ltd. - Canadian Licensed Medical Marijuana SupplierLink provided by the sponsor.
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Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Ware, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Mary Lynch, MD principal investigator
Queen Elizabeth II Health Science Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabis and Volcano® Medic Vapourizer in people with Osteoarthritis, Knee, run by Prairie Plant Systems Inc. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela D Perry, MSc (306-975-1207 ext. 1283, adp@prairieplant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.