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

NCT ID: NCT04760613

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-03
• Study Completion Date: 2023-06-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cannabidiol (CBD)

Group Type: ACTIVE_COMPARATOR

Cannabidiol

Intervention Type: DRUG

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

Placebo (PCB)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

identical capsules containing placebo (taken daily by mouth)

Interventions

Cannabidiol

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

Intervention Type: DRUG

Placebo

identical capsules containing placebo (taken daily by mouth)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Ross, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

19-A0-00-1002274

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

s21-00230

Identifier Type: -

Identifier Source: org_study_id