This double-blind, placebo-controlled, exploratory trial is designed to compare effects of oral CBD 600mg to placebo (PCB) in 20 outpatients with chronic spinal radiculopathies (without co-occurring Opioid Use Disorder), maintained on stable opioid analgesics for a minimum of 1 month. The trial duration will be approximately 2 weeks (from the point of randomization) of daily CBD 600mg vs placebo. Safety and tolerability of CBD will be assessed throughout the trial. The secondary efficacy outcome is change in pain outcomes from baseline to end of the treatment period at 2-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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
14
600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)
identical capsules containing placebo (taken daily by mouth)
NYU Langone Health
New York, New York, United States
Change in Opioid Analgesic Plasma Levels
Opioid (i.e. the particular opioid used by a participant) analgesic plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).
Time frame: Baseline, Week 2 Post-Initiation of Treatment
Change in CBD Plasma Levels
CBD plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).
Time frame: Day 1 Post-Initiation of Treatment, Week 2 Post-Initiation of Treatment
Change in Score on Pain Catastrophizing Scale (PCS)
PCS consists of 13 statements describing different thoughts and feelings that may be associated with pain. The degree to which one has these thoughts and feelings when experiencing pain is indicated on a scale of 0 (not at all) to 4 (all the time). The total range of score is 0-52, with a higher score indicating more frequent negative thoughts.
Time frame: Baseline, Week 2 Post-Initiation of Treatment
Change in Brief Pain Inventory (BPI) Score
BPI - Short Form is a self-administered questionnaire. It evaluates: 1. Pain intensity: 4 questions answered on a Likert scale of 0 (no pain) to 10 (pain as bad as you can imagine). 2. Pain-related interference: 7 categories answered on a Likert scale of 0 (does not interfere) to 10 (completely interferes). The composite mean of these scores is used as the total pain interference score: the total score ranges from 0-55; higher scores indicate greater pain interference.
Time frame: Baseline, Week 2 Post-Initiation of Treatment
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