Clinical trial · Interventional
Cannabis Oil for Pain Effectiveness
NCT03522467CI-TRIAL-00040839COPEunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chronic Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRCP001 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRCP001
- description
- MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID)
- interventionNames
- Drug: MRCP001
Primary outcomes (1)
- measure
- Sustained pain response
- timeFrame
- 43 days (Acute Phase)
- description
- 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)
Secondary outcomes (6)
- measure
- Pain response at any time
- timeFrame
- 43 days (Acute Phase) + 12 weeks (Chronic Phase)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.