# Medical Cannabis Evidence-Based Care: Phase 3 Trial Results > **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637) > **Publisher:** CED Clinic (https://cedclinic.com) > **Canonical URL:** https://cedclinic.com/phase-3-cannabis-trial-chronic-low-back-pain-results/ > **Published:** 2026-03-03T00:03:20-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T12:01:24-04:00 > **Clinical Summary:** Explore the phase 3 cannabis trial chronic low back pain results showing efficacy and safety of full-spectrum cannabis extract VER-01 in managing pain. --- #### Clinical Takeaway In this phase 3 trial of 820 adults with chronic low back pain, the full-spectrum cannabis extract VER-01 was evaluated over a 12-week double-blind treatment period with extensions up to one year. The study design follows rigorous clinical trial standards, providing higher-quality evidence than most prior cannabis pain research. Results from this trial carry meaningful weight for clinicians considering cannabis-based options for patients with chronic low back pain who have not responded adequately to conventional treatments. ### #2 Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial. **Citation:** Karst Matthias et al. *Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial.* Nature medicine. 2025. PMID: 41023483. **Study type:** Journal Article, Randomized Controlled Trial, Clinical Trial, Phase III, Multicenter Study  |  **Topic area:** Pain  |  **CED Score:** 14 Design: 5 Journal: 4 N: 2 Recency: 2 Pop: 2 Human: 1 Risk: -2 Why This Matters This phase 3 trial addresses a critical clinical gap by providing rigorous evidence for cannabis-based treatment in chronic low back pain, a condition affecting over 500 million people globally where current pharmacologic options demonstrate limited efficacy and notable safety liabilities. The double-blind, placebo-controlled design with 820 participants establishes a robust evidence base needed to inform clinical decision-making and potential regulatory approval for a full-spectrum cannabis extract as an alternative therapeutic option. These findings could substantially expand the treatment armamentarium for CLBP management, particularly for patients who are inadequately responsive to or intolerant of conventional analgesics. **Quality Gate Alerts:** - Preclinical only **Methodological Considerations:** - Open-label design — placebo effect not excluded **Abstract:** Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments offer limited efficacy and carry substantial risks, warranting the development of safe and effective alternatives. This multicenter, randomized, placebo-controlled phase 3 trial evaluated the efficacy and safety of VER-01 in CLBP. It enrolled 820 adults with CLBP (VER-01, n = 394; placebo, n = 426) and included a double-blind 12-week treatment phase (phase A), a 6-month open-label extension (phase B), followed by either a 6-month continuation (phase C) or randomized withdrawal (phase D). The primary endpoint of phase A was a change in mean numeric rating scale (NRS) pain intensity, with a change in total [neuropathic pain](https://cedclinic.com/cannabis-for-pain-relief/) symptom inventory (NPSI) score as a key secondary endpoint in participants with a neuropathic pain component (PainDETECT > 18). The primary endpoint for phase D was time to treatment failure. The study met its primary endpoint in phase A, with a mean pain reduction of -1.9 NRS points in the VER-01 group (mean difference (MD) versus placebo = -0.6, 95% confidence interval (CI) = -0.9 to -0.3; P < 0.001). Pain further decreased to -2.9 NRS points in phase B, with effects sustained through phase C. The study also met its key secondary endpoint of phase A, with a mean NPSI decrease of -14.4 (standard error, 3.3) points from baseline in the VER-01 arm (MD versus placebo = -7.3, 95% CI = -13.2 to -1.3; P = 0.017). Although phase D did not meet its primary endpoint (hazard ratio = 0.75, 95% CI = 0.44-1.27; P = 0.288), pain increased significantly more with placebo upon withdrawal (MD = 0.5, 95% CI = 0.0-1.0; P = 0.034). In phase A, the incidence of adverse events-mostly mild to moderate and transient-was higher with VER-01 than with placebo (83.3% versus 67.3%; P < 0.001). VER-01 was well-tolerated, with no signs of dependence or withdrawal. VER-01 shows potential as a new, safe and effective treatment for CLBP. ClinicalTrials.gov registration: NCT04 Clinical Perspective This phase 3 trial represents a meaningful contribution to the [cannabis medicine](https://cedclinic.com/essential-oils-industrial-hemp-antimicrobial-benefits/) literature, demonstrating that a standardized full-spectrum extract showed efficacy for chronic low back pain in a reasonably sized population, which is encouraging given the limitations of conventional pharmacotherapy in this indication. However, several important caveats warrant consideration: the study’s cannabinoid profile and specific THC to CBD ratio are not clearly detailed in the abstract, making it difficult to assess generalizability to other cannabis preparations; the mechanism of action remains incompletely understood; and longer-term safety and dependency potential data appear to be limited to the open-label extension phase, which lacks the rigor of blinded assessment. Additionally, as with most cannabis trials, patient expectations and subjective symptom reporting may introduce bias despite randomization. Clinically, while these results may support considering full-spectrum cannabis as an option for carefully selected patients with CLBP who have failed or are intolerant to conventional treatments, providers should still obtain detailed baseline pain and functional status metrics, monitor for  |   |  Further Reading Cannabis Policy Wire[Policy Watch: 20 Regulatory Updates — March 10, 2026](https://cedclinic.com/dea-scheduling-synthetic-opioids-regulatory-updates-2026/) Research Digest[Daily Digest 2026-03-07](https://cedclinic.com/adolescent-cannabis-psychiatric-outcomes-2026-digest/) CED Clinic Blog[Cannabis-Infused Beverages as Alcohol Alternatives: New York at Five Years](https://cedclinic.com/cannabis-beverage-substitution-alcohol-new-york-five-years/) [View on PubMed ↗](https://pubmed.ncbi.nlm.nih.gov/41023483/)[Full Text ↗](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12705446/)[DOI ↗](https://doi.org/10.1038/s41591-025-03977-0) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) Physician-Led, Whole-Person Care A doctor who takes the time to truly understand you. Personal care that starts with listening and is guided by experience and ingenuity. Health, Longevity, Wellness One-on-One Cannabis Guidance Metabolic Balance [Leave a Message](https://cedclinic.com/contact/) [Metabolic Care](https://cedclinic.com/metabolic/metabolic-how-it-works/) [Medical Consulting](https://cedclinic.com/book/) [Cannabis Care](https://cedclinic.com/book/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) RELATED READING AT CED CLINIC Continue exploring the evidence [Cannabis Sativa Extracts for Chronic Low Back Pain: A Phase 3 Randomized Trial](https://cedclinic.com/phase-3-cannabis-trial-chronic-low-back-pain-results/) Detailed results from a phase 3 [randomized trial](https://cedclinic.com/cannabis-cannabinoids-therapeutic-applications-review/) evaluating cannabis sativa extracts for chronic low back pain. [Read More](https://cedclinic.com/phase-3-cannabis-trial-chronic-low-back-pain-results/) [Endocannabinoid System Trial: Cannabis for Chronic Back Pain](https://cedclinic.com/ver-01-cannabis-extract-clinical-trial-chronic-back-pain/) Insights into the role of the [endocannabinoid system](https://cedclinic.com/endocannabinoid-system-fear-extinction/) in managing chronic back pain with cannabis. [Explore Study](https://cedclinic.com/ver-01-cannabis-extract-clinical-trial-chronic-back-pain/) [Endocannabinoid System & Chronic Low Back Pain: Phase 3 Trial Results on Cannabis Sativa Extracts](https://cedclinic.com/phase-3-randomized-controlled-trial-chronic-low-back-pain/) Comprehensive analysis of phase 3 trial results on cannabis sativa extracts for chronic low back pain. [Learn More](https://cedclinic.com/phase-3-randomized-controlled-trial-chronic-low-back-pain/) Have thoughts on this? 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