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RECRUITING
NCT05351801
PHASE2

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2023-06-21

Completion Date

2029-05-31

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DRUG

THC (Syndros)

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

DRUG

CBD (Epidolex)

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

DRUG

THC + CBD (Nabiximols)

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

DRUG

Placebo

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