Cannabis Oil for Pain Effectiveness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-25

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer Chronic Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, single-arm cohort

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MRCP001

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

Group Type EXPERIMENTAL

MRCP001

Intervention Type DRUG

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

Interventions

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MRCP001

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

Intervention Type DRUG

Other Intervention Names

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Cannabis oil capsule

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No