Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial.

Summary

In a multicenter phase 3 RCT (n=820), a full-spectrum cannabis extract (VER-01) produced a statistically significant, modest reduction in chronic low back pain versus placebo over 12 weeks and improved neuropathic pain symptoms in a predefined subgroup. Adverse events were more frequent but mainly mild-to-moderate, and no dependence or withdrawal was observed.

Key Findings

• Met the primary endpoint: mean NRS pain reduction −1.9 with VER-01; MD vs placebo −0.6 (95% CI −0.9 to −0.3; P<0.001).
• Neuropathic pain subgroup: NPSI decreased −14.4; MD vs placebo −7.3 (95% CI −13.2 to −1.3; P=0.017).
• Randomized withdrawal phase did not meet primary endpoint (HR 0.75; P=0.288), but pain increased more with placebo upon withdrawal (MD 0.5; P=0.034).
• Adverse events were more frequent with VER-01 (83.3% vs 67.3%) but were mostly mild-to-moderate and transient; no dependence/withdrawal observed.

Clinical Implications

VER-01 may be considered as an adjunct or alternative in multimodal chronic low back pain management, with counseling on modest effect size, higher mild-to-moderate AEs, and close monitoring. Health systems should weigh potential benefits against costs and regulatory considerations.

Limitations

• Effect size was modest (MD −0.6 on NRS).
• Higher overall adverse event rates versus placebo; long-term safety beyond study duration not fully established.

Future Directions

Conduct head-to-head comparisons with standard analgesics, evaluate functional outcomes and cost-effectiveness, and assess long-term safety and dependency risk in broader populations.