Phase 2 Study of Cannabis Components THC, CBD, and Their Combination for Treating Neuropathic Pain in Veterans

What this Trial Is About

Chronic neuropathic pain CNP is a disabling condition that particularly affects United States Veterans. Current frontline treatments for CNP have inconsistent results and often cause dissatisfaction. Veterans and clinicians have shown strong interest in cannabis derivatives like THC and CBD for pain control, but well-controlled trials are lacking to guide expectations about benefits and side effects. This randomized phase II trial aims to evaluate cannabis constituents in Veterans with CNP, addressing a vital need given their unique pain profiles and treatment challenges. The trial compares three cannabis-based treatmentsTHC, CBD, and a combination of THC plus CBDwith a placebo. Participants will receive target doses of 10 mg per day of THC, 800 mg per day of CBD, or 10.8 mg10 mg per day of the THCCBD combination. The study uses a quadruple-masked, randomized design with four arms to assess these treatments over a short-term period. The placebo looks identical to the active treatments to maintain masking. Participants are adult Veterans diagnosed with high-impact neuropathic pain who are stable on current treatments and not using cannabis currently. The study involves multiple assessments including pain ratings using the Numeric Rating Scale, sensory testing, function and disability scales, gait speed tests, quality of life surveys, and mental health questionnaires. These are conducted at baseline and at intervals up to 8 weeks. The trial measures both benefits and adverse effects of cannabinoids, with close monitoring of participant adherence and health.

Proof of Concept Trial of Cannabis Derivatives in Neuropathic Pain