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

NCT04760613 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: s21-0023019-A0-00-1002274
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiculopathy

Keywords

Cannabidiol

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Day 1 Post-Initiation of Treatment, Week 2 Post-Initiation of Treatment

Secondary Outcomes (2)

• Change in Score on Pain Catastrophizing Scale (PCS)

  Baseline, Week 2 Post-Initiation of Treatment

• Change in Brief Pain Inventory (BPI) Score

  Baseline, Week 2 Post-Initiation of Treatment

Study Arms (2)

Cannabidiol (CBD)

ACTIVE COMPARATOR

Drug: Cannabidiol

Placebo (PCB)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Cannabidiol DRUG

600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)

Cannabidiol (CBD)

Placebo DRUG

identical capsules containing placebo (taken daily by mouth)

Placebo (PCB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Radiculopathy

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Stephen Ross, MD
• Organization: NYU Langone health

Stephen.ross@nyulangone.org

212-263-6289

Study Officials

• Stephen Ross, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The trial will employ a double-blind pharmacologic intervention methodology where the investigational drug (CBD) and matched placebo oral pills will be masked in identically appearing capsules provided by the drug sponsor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 18, 2021
• Study Start: February 3, 2022
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to Stephen.ross@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)