Phase 3 Trial: Full-Spectrum Cannabis Extract Significantly Reduces Chronic Low Back Pain

VER-01 met its primary endpoint with a mean pain reduction of 1.9 NRS points (vs. placebo difference of -0.6 points, p < 0.001) over 12 weeks. Pain continued decreasing to -2.9 points during the 6-month open-label extension. For neuropathic pain, NPSI scores decreased by 14.4 points (vs. placebo difference of -7.3, p = 0.017). No signs of dependence or withdrawal were observed.

Multicenter, randomized, placebo-controlled phase 3 trial with 820 adults with chronic low back pain. Included a 12-week double-blind phase, 6-month open-label extension, and randomized withdrawal phase. Published in Nature Medicine.

This is one of the largest and most rigorous RCTs of a cannabis-based medicine for chronic pain to date, published in a top-tier journal. Chronic low back pain affects over half a billion people globally, and current medications carry substantial risks.

If confirmed by further trials, this could shift the conversation about cannabis for chronic pain from anecdotal reports and small studies to evidence-based medicine. The absence of dependence signals after extended use addresses one of the key concerns about cannabinoid therapies.

Higher adverse event rate (83.3% vs. 67.3%), though events were mostly mild and transient. The randomized withdrawal phase did not meet its primary endpoint on time to treatment failure. Open-label extension phases lack placebo control.