Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-03-09 @ 2:43 PM
Study NCT ID:
NCT03522467
Status:
UNKNOWN
Last Update Posted:
2019-09-25
First Post:
2018-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabis Oil for Pain Effectiveness
Sponsor:
Aurora Cannabis Inc
Organization:
Study Overview
Official Title:
Cannabis Oil for Pain Effectiveness
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: