drugset / Trial / NCT05351801

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

NCT05351801 ↗

Phase 2 Recruiting 320 enrolled VA Office of Research and Development
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-06-21
Primary completion
2028-09-29
Completion
2029-05-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Epidolex Unknown 10 mg —
Comparator Epidolex Unknown 800 mg —
Comparator Syndros Unknown 10 mg —
Comparator Syndros Unknown 10.8 mg —

Indications