Cannabis Oil for Pain Effectiveness

Official Title

Cannabis Oil for Pain Effectiveness

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.

Trial Description

Primary Outcome:

• Sustained pain response

Secondary Outcome:

• Pain response at any time
• Toxicity of treatment intervention - incidence and grade of AEs
• Anxiety and depression
• Functional well-being
• Quality of life change
• Neuropathic pain

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.

View this trial on ClinicalTrials.gov