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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: Completed Phase 1 study, sponsored by NYU Langone Health.
NCT04760613 is a Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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).
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 |
What the finished NCT04760613 record still lists
NCT04760613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04760613 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04760613's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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