CBD for Chronic Radiculopathy on Chronic Opioid Therapy (COT)
Status:
Not yet recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
Summary
This double-blind, placebo-controlled, proof-of-concept trial is designed to compare effects
of oral CBD 600mg to placebo (PCB) in 40 outpatients with chronic spinal radiculopathies
(without co-occurring Opioid Use Disorder), maintained on stable moderate to high-dose opioid
analgesics for a minimum of 3-months, and motivated to decrease their opioid analgesic
maintenance dose. The trial duration will be 6-months (from the point of randomization) and
will include a 4-month treatment period (following randomization) of daily CBD 600mg vs
placebo, followed by 2 months off of study medication or placebo. Safety and tolerability of
CBD will be assessed throughout the trial. The primary efficacy outcome is change in opioid
maintenance dose from baseline to end of the treatment period at 16-weeks
post-randomization/initiation of treatment with a Mixed Model for Repeated Measures (MMRM)
statistical analysis performed to assess between group treatment effects of CBD relative to
placebo.