RecruitingPhase 2NCT05351801

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain


Sponsor

VA Office of Research and Development

Enrollment

320 participants

Start Date

Jun 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CBD (Epidolex), a drug called Placebo, and others for people with neuropathic pain and peripheral neuropathic pain. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTHC (Syndros)

Participants will receive a target dose of 10mg per day of THC (Syndros).

DRUGCBD (Epidolex)

Participants will receive a target dose of 800 mg per day of CBD (Epidolex).

DRUGTHC + CBD (Nabiximols)

Participants will receive a target dose of 10.8 mg / 10 mg per day of THC + CBD (Nabiximols).

DRUGPlacebo

Placebo


Locations(6)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, United States

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05351801


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