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NCT05351801 · ClinicalTrials.gov registry record · Phase 2
Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain
A Phase 2 study of Neuropathic Pain and Peripheral Neuropathic Pain, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 320
- Enrollment target
- 6
- Study locations
NCT05351801: Recruiting Phase 2 study of Neuropathic Pain and Peripheral Neuropathic Pain, sponsored by VA Office of Research and Development.
NCT05351801 is a Phase 2 study of Neuropathic Pain and Peripheral Neuropathic Pain that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 320 participants, above the 92-participant average among 35 other Neuropathic Pain trials with a reported enrollment target (248% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05351801, a Phase 2 study of Neuropathic Pain and Peripheral Neuropathic Pain, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 320 participants
- Enrollment target
- 6
- Study locations
Study Summary
Chronic neuropathic pain (CNP) is disabling. Research on frontline treatments for CNP, shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabis derivatives (THC, CBD) for neuropathic pain control, but there are no well-controlled trials guiding expectations for benefit and adverse outcomes associated with cannabis for CNP. Because Veterans are likely to present with pain and pain-related polymorbidity significantly differing from that of civilians, a well-structured clinical trial of cannabinoids for Veterans with CNP is vital.
Primary Outcome
The mean change in the weekly average of daily Numeric Rating Scale (NRS) pain score (0-10 scale; 0=no pain, 10=worst possible pain) from baseline to week 6.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG THC (Syndros)
- DRUG CBD (Epidolex)
- DRUG THC + CBD (Nabiximols)
Study Locations (6)
California
- VA San Diego Healthcare System, San Diego, CA - San Diego
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA - West Los Angeles
Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT - West Haven
Rhode Island
- Providence VA Medical Center, Providence, RI - Providence
Texas
- South Texas Health Care System, San Antonio, TX - San Antonio
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2023-06-21 |
| Est. Completion | 2029-05-31 |
| Phase | Phase 2 |
What NCT05351801 shows while recruiting
NCT05351801 is an interventional study that assigns participants to a tested intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, above the 92-participant average among 35 other Neuropathic Pain trials with a reported enrollment target (248% higher).
The record links to 2 conditions, with Neuropathic Pain appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05351801 lists 6 locations in 5 states (California, Connecticut, Rhode Island).
Frequently Asked Questions
What is clinical trial NCT05351801 about?
NCT05351801 is a clinical study titled "Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain". Chronic neuropathic pain (CNP) is disabling. Research on frontline treatments for CNP, shows inconsistent outcomes and dissatisfaction among Veterans. Veterans and clinicians have shown significant interest in cannabis derivatives (THC, CBD) for neuropathic pain control, but there are no well-contro...
What is the current status of trial NCT05351801?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2023-06-21. Estimated completion is 2029-05-31.
What conditions does trial NCT05351801 study?
This clinical trial studies the following conditions: Neuropathic Pain, Peripheral Neuropathic Pain.
What interventions are being tested in trial NCT05351801?
The interventions under investigation include: Placebo (DRUG), THC (Syndros) (DRUG), CBD (Epidolex) (DRUG), THC + CBD (Nabiximols) (DRUG).
Who is sponsoring clinical trial NCT05351801?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05351801 being conducted?
This trial has 6 study locations across California, Connecticut, Rhode Island, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05351801's enrollment target sits among peer trials
320 4th of 35 higher than 32 of 35 other Neuropathic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuropathic Pain 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.
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