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

Primary Purpose

Radiculopathy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cannabidiol

Placebo

About this trial

This is an interventional treatment trial for Radiculopathy focused on measuring Cannabidiol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cannabidiol (CBD)

Placebo (PCB)

Arm Description

Outcomes

Primary Outcome Measures

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).

Change in CBD Plasma Levels

CBD plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).

Secondary Outcome Measures

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.

Change in Brief Pain Inventory (BPI) Score

BPI - Short Form is a self-administered questionnaire. It evaluates: 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. 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.

Full Information

NCT ID

NCT04760613

First Posted

February 17, 2021

Last Updated

September 15, 2023

Sponsor

NYU Langone Health

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT04760613

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

February 3, 2022 (Actual)

Primary Completion Date

June 7, 2023 (Actual)

Study Completion Date

June 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiculopathy

Keywords

Cannabidiol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cannabidiol (CBD)

Arm Type

Active Comparator

Arm Title

Placebo (PCB)

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Cannabidiol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

identical capsules containing placebo (taken daily by mouth)

Primary Outcome Measure Information:

Title

Change in Opioid Analgesic Plasma Levels

Description

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

Week 0, Week 2

Title

Change in CBD Plasma Levels

Description

CBD plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).

Time Frame

Week 0, Week 2

Secondary Outcome Measure Information:

Title

Change in Score on Pain Catastrophizing Scale (PCS)

Description

Time Frame

Week 0, Week 2

Title

Change in Brief Pain Inventory (BPI) Score

Description

Time Frame

Week 0, Week 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Ross, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU Langone Health

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing 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.

Learn more about this trial

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

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