Radiculopathy
Conditions
Keywords
Cannabidiol
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.
Interventions
DRUGCannabidiol
600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)
DRUGPlacebo
identical capsules containing placebo (taken daily by mouth)
Sponsors
National Institute on Drug Abuse (NIDA)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
There were n=8 participants who were enrolled but failed screening/did not start the trial. Thus, the total number of participants who started the trial is n=6.
Participants by arm
| Arm | Count |
|---|---|
| Cannabidiol (CBD) Cannabidiol: 600 mg oral daily use (each capsule of active drug contains 50 mg of CBD) | 5 |
| Placebo (PCB) Placebo: identical capsules containing placebo (taken daily by mouth) | 1 |
| Total | 6 |
Baseline characteristics
| Characteristic | Cannabidiol (CBD) | Total | Placebo (PCB) |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 10.533 | 59.9 years STANDARD_DEVIATION 10.533 | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 5 participants | 6 participants | 1 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 1 |
| other Total, other adverse events | 5 / 5 | 1 / 1 |
| serious Total, serious adverse events | 0 / 5 | 1 / 1 |
Outcome results
Primary
Change in CBD Plasma Levels
CBD plasma levels will be determined via High Performance Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS).
Time frame: Day 1 Post-Initiation of Treatment, Week 2 Post-Initiation of Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cannabidiol (CBD) | Change in CBD Plasma Levels | 38.28 ng/mL | Standard Deviation 31.44 |
| Placebo (PCB) | Change in CBD Plasma Levels | 0 ng/mL | — |
Primary
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).
Time frame: Baseline, Week 2 Post-Initiation of Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cannabidiol (CBD) | Change in Opioid Analgesic Plasma Levels | 10.86 ng/mL | Standard Deviation 14.35 |
| Placebo (PCB) | Change in Opioid Analgesic Plasma Levels | -11.4 ng/mL | — |
Secondary
Change in Brief Pain Inventory (BPI) Score
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.
Time frame: Baseline, Week 2 Post-Initiation of Treatment
Population: The participant in the Placebo (PCB) arm did not complete the PCS questionnaire at the Week 2 timepoint so change data was not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cannabidiol (CBD) | Change in Brief Pain Inventory (BPI) Score | -1.52 score on a scale | Standard Deviation 1.49 |
Secondary
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.
Time frame: Baseline, Week 2 Post-Initiation of Treatment
Population: The participant in the Placebo (PCB) arm did not complete the PCS questionnaire at the Week 2 timepoint so change data was not collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cannabidiol (CBD) | Change in Score on Pain Catastrophizing Scale (PCS) | 0.6 score on a scale | Standard Deviation 8.65 |