Recruiting
Phase 2

Cannabis Oil

Sponsor:

Aurora Cannabis Inc

Code:

NCT03522467

Conditions

Cancer

Chronic Pain

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Not accepted

Interventions

MRCP001

Study Details

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.

Conditions

Cancer

Chronic Pain

Study ID

NCT03522467

Start date

Jul 25, 2018

Status verified date

Sep, 2019

Completion date

Sep, 2020

Anticipated

Primary completion date

Jun, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MRCP001

MRCP001 administered per protocol dose titration regimen (beginning at 1 capsule daily, titrated to a maximum of 3 capsules BID)

Interventions

MRCP001

MRCP001 is a formulated whole-plant cannabis oil extract, that may help manage poorly controlled chronic pain.

Primary outcome measure

  • Sustained pain response [ Time Frame: 43 days (Acute Phase) ]

Central Contacts and Locations

Central contacts

Locations

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Principal Investigator:

Marissa Slaven, MD

More Information

Sponsor

Aurora Cannabis Inc

Last update posted

Sep 25, 2019

Last verified

Sep, 2019

Keywords

  • Cannabis oil
  • Cannabis
  • Pain
  • Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aurora Cannabis Inc on 2019-09-25.