Cannabis Oil for Pain Effectiveness (COPE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03522467|
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : July 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer Chronic Pain||Drug: MRCP001||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, single-arm cohort|
|Masking:||None (Open Label)|
|Official Title:||Cannabis Oil for Pain Effectiveness|
|Actual Study Start Date :||July 25, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||September 2019|
MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID)
MRCP001 is a formulated whole-plant cannabis oil extract, that may help manage poorly controlled chronic pain.
Other Name: Cannabis oil capsule
- Sustained pain response [ Time Frame: 43 days (Acute Phase) ]Two successive pain responses (Reduction in pain as measured by the Brief Pain Inventory - Short form (BPI-SF) with no increase MME or decrease in MME, continuing for 7 days after dose stabilization)
- Pain response at any time [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]Reduction in pain as measured by the BPI-SF with no increase MME or decrease in MME
- Toxicity of treatment intervention - incidence and grade of AEs [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]As measured by NCIC CTE
- Anxiety and depression [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]As measured by the Hospital Anxiety and Depression Scale (HADS) in which 14 questions are scored on a scale of 0-3. A cumulative score of ≥ 11 will result in a subject being classified as having anxiety and depression using the HADS anxiety and depression, respectively.
- Functional well-being [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]As measured by the Edmonton Symptom Assessment Scale (ESAS), which is routinely performed in most cancer centres in Ontario, and scores pain as well as other cancer-related symptoms between 0-10, 10 being worst possible.
- Quality of life [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]As measured by the Functional Assessment of Cancer Therapy (FACT-G)
- Neuropathic pain [ Time Frame: 43 days (Acute Phase) + 12 weeks (Chronic Phase) ]As measured by the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), a scale which assigns scores between 0-5 to 7 pain-related outcomes, a cut off ≥ 12 classifying subjects as predominantly having neuropathic pain.
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): NCT03522467
|Contact: Lisa Rudd-Scott||905-527-2299 ext email@example.com|
|Contact: Erin McGean||905-527-2299 ext firstname.lastname@example.org|
|Juravinski Cancer Centre||Recruiting|
|Hamilton, Ontario, Canada, L8V 5C2|
|Principal Investigator: Marissa Slaven, MD|
|Principal Investigator:||Marissa Slaven, MD||Hamilton Health Sciences Corporation|