Investigational Cannabis Extract Shows Pain Relief in Chronic Low Back Pain
A new trial published in the journal of Nature Medicine found participants taking VER-01 reported clinically significant and sustained pain relief for over a year in patients with chronic low back pain (CLBP). While findings support its potential role in nonsurgical back pain management, comparisons with other active therapies remain unclear.
Existing pharmacologic treatments often provide only limited relief and carry prominent risks, from gastrointestinal complications to dependency concerns. The findings from a large phase 3 clinical trial suggest that an experimental drug, VER-01, could represent a meaningful advance in treatment.
This trial enrolled 820 adults with CLBP across several international sites. The participants were randomized to receive either VER-01 (394 patients) or placebo (426 patients). The trial design included a 12-week double-blind phase (phase A), followed by a 6-month open-label extension (phase B). The patients could then either continue treatment for another 6 months (phase C) or enter a randomized withdrawal stage (phase D).
The trial met its main goal in phase A. The patients receiving VER-01 reported a mean reduction of 1.9 points on the numeric rating scale (NRS) for pain intensity, compared to a reduction of 1.3 points with placebo. This translated into a statistically significant difference of −0.6 points (95% CI, −0.9 to −0.3; P < 0.001). Also, pain relief deepened with continued use, where the average NRS pain scores dropped by 2.9 points from baseline, and these improvements were maintained through phase C.
A key secondary endpoint focused on patients with neuropathic features of back pain, identified by PainDETECT scores above 18. In this subgroup, VER-01 reduced scores on the Neuropathic Pain Symptom Inventory (NPSI) by 14.4 points, when compared with a placebo-adjusted mean difference of −7.3 (95% CI, −13.2 to −1.3; P = 0.017).
Phase D tested whether patients maintained benefit after withdrawal, did not reach statistical significance for its primary measure of treatment failure (hazard ratio = 0.75; P = 0.288). However, pain levels rose more sharply in those switched to placebo, with a mean difference of 0.5 points versus those who continued VER-01 (P = 0.034).
Side effects were more common with VER-01 than placebo in the blinded phase (83.3% vs. 67.3%). Most events were mild to moderate and short-lived. Importantly, this study observed no evidence of dependence or withdrawal symptoms, a concern with several currently available therapies for CLBP. Overall, the data suggest that VER-01 could become a new, safe, and effective option for patients with chronic low back pain, particularly those with a neuropathic component.
Source:
Karst, M., Meissner, W., Sator, S., Keßler, J., Schoder, V., & Häuser, W. (2025). Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial. Nature Medicine, 1–8. https://doi.org/10.1038/s41591-025-03977-0
