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NCT04760613 · ClinicalTrials.gov registry record · Phase 1
CBD for Chronic Radicular Pain on Chronic Opioid Therapy (COT)
A Phase 1 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT04760613 is a Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 14 participants.
The verdict
NCT04760613, a Phase 1 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study 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
- DRUG Placebo
- DRUG Cannabidiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-02-03 |
| Est. Completion | 2023-06-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04760613
The ClinicalTrials.gov registry entry for NCT04760613 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04760613 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04760613 about?
NCT04760613 is a clinical study titled "CBD for Chronic Radicular Pain on Chronic Opioid Therapy (COT)". 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 dura...
What is the current status of trial NCT04760613?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2022-02-03. Estimated completion is 2023-06-07.
What interventions are being tested in trial NCT04760613?
The interventions under investigation include: Placebo (DRUG), Cannabidiol (DRUG).
Who is sponsoring clinical trial NCT04760613?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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