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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04760613
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : August 29, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Radiculopathy Drug: Cannabidiol Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Phase I/II, Randomized, Double-blind, Placebo-controlled, Single-center Study of the Effects of Cannabidiol (CBD) on Opioid Plasma Levels in Participants With Chronic Radiculopathic Pain Syndromes Maintained on Chronic Opioid Therapy (COT)
Actual Study Start Date : February 3, 2022
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Active Comparator: Cannabidiol (CBD) Drug: Cannabidiol
600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)

Placebo Comparator: Placebo (PCB) Drug: Placebo
identical capsules containing placebo (taken daily by mouth)




Primary Outcome Measures :
  1. Change in Opioid Analgesic Plasma Levels [ Time Frame: Week 0, Week 2 ]
    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).

  2. Change in CBD Plasma Levels [ Time Frame: Week 0, Week 2 ]
    CBD plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).


Secondary Outcome Measures :
  1. Change in Score on Pain Catastrophizing Scale (PCS) [ Time Frame: Week 0, Week 2 ]
    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.

  2. Change in Brief Pain Inventory (BPI) Score [ Time Frame: Week 0, Week 2 ]

    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). Total range of score is 0-40, where a higher score indicates more intense pain.
    2. Pain-related interference: 7 categories answered on a Likert scale of 0 (does not interfere) to 10 (completely interferes). Total range of score is 0-70, where a higher score indicates more pain-related interference.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760613


Contacts
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Contact: Stephen Ross, MD 212-263-6289 Stephen.ross@nyulangone.org
Contact: Angela West, MA 212-263-6283 angela.west@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Angela West, MA    212-263-6283    angela.west@nyulangone.org   
Principal Investigator: Stephen Ross, MD         
Sponsors and Collaborators
NYU Langone Health
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Stephen Ross, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04760613    
Other Study ID Numbers: s21-00230
19-A0-00-1002274 ( Other Grant/Funding Number: NIDA-CTN )
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: August 29, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Cannabidiol
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cannabidiol
Anticonvulsants