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

NCT04760613 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-09-19

Study results available
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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

Interventions

DRUG

Cannabidiol

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

DRUG

Placebo

identical capsules containing placebo (taken daily by mouth)

Sponsors & Collaborators

Principal Investigators

  • Stephen Ross, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-03
Primary Completion
2023-06-07
Completion
2023-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04760613 on ClinicalTrials.gov