Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : September 25, 2019
Sponsor:
Collaborators:
Ontario Clinical Oncology Group (OCOG)
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Aurora Cannabis Inc

Tracking Information
First Submitted Date  ICMJE April 27, 2018
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE July 25, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • 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 change [ 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabis Oil for Pain Effectiveness
Official Title  ICMJE Cannabis Oil for Pain Effectiveness
Brief Summary This project represents a first systematic, prospective, single-arm cohort study of a safe and effective dosing regimen of an orally administered cannabis oil formulation in a cancer subject population with poorly controlled pain.
Detailed Description Over a 1-2 year period, 40 cancer patients experiencing poorly controlled pain will be enrolled in to a prospective single-arm cohort study, in which they will receive an orally administered cannabis oil formulation as an add-on therapy to current treatment regimens. Subjects entering the acute study phase will be titrated to a tolerated dose at which a sustained pain response is reached, and may subsequently enter a 12 week chronic phase during which safety and durability of pain response will be assessed at their stable dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, single-arm cohort
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Chronic Pain
Intervention  ICMJE Drug: MRCP001
MRCP001 is a formulated whole-plant cannabis oil extract, that may help manage poorly controlled chronic pain.
Other Name: Cannabis oil capsule
Study Arms  ICMJE Experimental: MRCP001
MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID)
Intervention: Drug: MRCP001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women with breast, prostate, lung, gastrointestinal or genitourinary cancer who have poorly controlled pain defined by the use of three or more PRN, or as needed, doses of opioids in a 24-hour period for a minimum of three days per week in the week prior to study registration.
  2. Age 25-70 years.
  3. An ESAS score of 2 or more recorded as their worst pain at the time of study registration.

Exclusion Criteria:

  1. Current use of cannabis within the last 30 days from date of study consent (urine screen test positive).
  2. Brain metastases.
  3. ECOG performance > 2.
  4. Life expectancy < 6 months.
  5. Daily morphine milligram equivalent (MME) dose < 15 or > 120.
  6. Current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent or psychosis that could be exacerbated by the administration of cannabis.
  7. Chemotherapy induced neuropathy.
  8. Poorly controlled hypertension, unstable angina, or myocardial infarction within the previous 6 months.
  9. Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular (e.g. arrhythmias, ischemic heart disease, tachycardia), cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric (e.g. depression, disorientation, euphoric mood and dissociation), dermatological or hematological disease or condition unless determined as not clinically significant.
  10. Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or are currently pregnant or lactating.
  11. Anticipated change in chemotherapy or radiotherapy treatment plan during the 43-day course of the acute study.
  12. Known history of substance abuse.
  13. Inability to speak or read English.
  14. Inability to provide informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa Rudd-Scott 905-527-2299 ext 43793 ruddl@mcmaster.ca
Contact: Erin McGean 905-527-2299 ext 42656 mcgeane@mcmaster.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03522467
Other Study ID Numbers  ICMJE OCOG-2017-COPE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aurora Cannabis Inc
Study Sponsor  ICMJE Aurora Cannabis Inc
Collaborators  ICMJE
  • Ontario Clinical Oncology Group (OCOG)
  • Hamilton Health Sciences Corporation
Investigators  ICMJE
Principal Investigator: Marissa Slaven, MD Hamilton Health Sciences Corporation
PRS Account Aurora Cannabis Inc
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP