CBD for Chronic Radiculopathy on Chronic Opioid Therapy (COT)

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cannabidiol; Epidiolex

Criteria

Inclusion Criteria:

• Males and females aged ≥18

• Diagnosis of radicular CNCP (i.e. lumbar, cervical, thoracic)

• Maintained on moderate to high dose opioid therapy [morphine-equivalent daily dose (MEDD) ≥ 50 mg/d] for a minimum of 3-months

o Note: 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

• Express a motivation to decrease their opioid analgesic maintenance dose

• Willingness to allow for initial and ongoing communication between study team and treatment provider(s) prescribing chronic opioid therapy for radicular CNCP1

• 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 (serious abnormalities of complete blood count or chemistries, significantly impaired liver function2)

• Current substance use disorder (including Opioid Use Disorder) other than nicotine or caffeine

• 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 serious suicide attempts requiring hospitalization

• 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