Cannabis Oil for Pain Effectiveness
Unknown statusPhase 2NCT03522467
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
Brief summary (from the registry)
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.
Study details
- Official title
- Cannabis Oil for Pain Effectiveness
- Conditions
- Interventions
- Drug: MRCP001
- Sponsor
- Aurora Cannabis Inc
- Collaborators
- Ontario Clinical Oncology Group (OCOG); Hamilton Health Sciences Corporation
- Start date
- 2018-07-25
- Primary completion
- 2020-06
- Sex
- All
- Age range
- from 25 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03522467