CBD for Chronic Radicular Pain on Chronic Opioid Therapy (COT)

Phase 1

Completed

Conditions: Radiculopathy

Interventions: Drug: Cannabidiol
Drug: Placebo

Registration Number: NCT04760613

Lead Sponsor: NYU Langone Health

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

Inclusion Criteria

Males and females aged ≥18
Diagnosis of radicular CNCP (i.e. lumbar, cervical, thoracic)
Maintained on stable dose opioid therapy for a minimum of 1 month

o Note: Morphine Equivalent Daily Dose (MEDD) will be calculated using 2 reference documents: Guideline and conversion table to calculate MEDD from Centers for Medicaid and Medicare Services (CMS); Guidelines from the Centers for Disease Control and Prevention (CDC) intended for calculating total daily dose of opioids for safer dosage of opioid pharmacotherapy
Able to provide voluntary informed consent
If a woman of childbearing potential or a man, are willing to use approved form of contraception from screening for duration of the trial

Exclusion Criteria

Exclusionary medical conditions (e.g., unstable cardiac, hepatic, renal, neurologic illness) or any medical illness that in the opinion of the study physician poses a potential medical danger to the participant
Exclusionary laboratory abnormalities (clinically significant abnormalities of complete blood count or chemistries, significantly impaired liver function)
Current substance use disorder (including Opioid Use Disorder) other than nicotine or caffeine
At screening, a positive urine toxicology test for: amphetamines (AMP), barbiturates (BAR), buprenorphine (BUP), benzodiazepines (BZO), cocaine (COC), 3,4-methylenedioxymethamphetamine (MDMA), methamphetamine (MET), methadone (MTD), phencyclidine (PCP), and tetrahydrocannabinol (THC)
At screening, an alcohol level greater than 0 on a breathalyzer
Severe psychiatric conditions including past or current DSM5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder
Current significant suicidality (assessed using the C-SSRS), any suicidal behavior in the past 12 months, or any history of suicide attempts
Current use of recreational or medical cannabis or any product containing CBD
Pregnancy or lactation
Current use of concomitant medications metabolized primarily by CYP2C19 isoenzymes
Current use of concomitant medications significantly or primarily metabolized by CYP3A4 with the potential for adverse drug-drug interactions with CBD (i.e., ketoconazole, rifampicin)
Current use of concomitant medications with a narrow therapeutic window significantly or primarily metabolized by CYP2C9 with the potential for adverse drug-drug interactions with CBD (i.e., warfarin)
Current use of concomitant medications known to have adverse drug-drug interactions with CBD (i.e., valproate) or the potential to cause significant drug-drug interactions (i.e., clobazam).
Known allergy to CBD or any ingredient of the study compound
Currently enrolled in a clinical trial assessing the effects of an anti-pain intervention

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cannabidiol (CBD)	Cannabidiol	-
Placebo (PCB)	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Opioid Analgesic Plasma Levels	Baseline, Week 2 Post-Initiation of Treatment	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).
Change in CBD Plasma Levels	Day 1 Post-Initiation of Treatment, Week 2 Post-Initiation of Treatment	CBD plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).

Secondary Outcome Measures

Name	Time	Method
Change in Score on Pain Catastrophizing Scale (PCS)	Baseline, Week 2 Post-Initiation of Treatment	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.
Change in Brief Pain Inventory (BPI) Score	Baseline, Week 2 Post-Initiation of Treatment	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.