# Cannabinoid Clinical Trials: Full-Spectrum Cannabis for Back Pain > **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637) > **Publisher:** CED Clinic (https://cedclinic.com) > **Canonical URL:** https://cedclinic.com/full-spectrum-cannabis-extract-chronic-low-back-pain-trial/ > **Published:** 2026-03-04T09:50:04-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T17:09:58-04:00 > **Clinical Summary:** Explore the phase 3 trial of full-spectrum cannabis extract for chronic low back pain showing potential efficacy and safety in pain management. --- #### Clinical Takeaway In this phase 3 randomized controlled trial of 820 adults with chronic low back pain, the full-spectrum cannabis extract VER-01 was evaluated over a 12-week double-blind period with up to 12 months of follow-up. The trial design includes a randomized withdrawal phase, allowing researchers to assess both sustained benefit and whether effects depend on continued use. Results from this study will help clarify whether a standardized full-spectrum cannabis extract can serve as a viable, evidence-based option 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 conventional pharmacotherapy has demonstrated limited efficacy and tolerability issues. The large sample size (820 participants) and double-blind design with extended follow-up strengthen the validity of efficacy and safety findings, potentially establishing a new therapeutic option for patients who fail or cannot tolerate standard analgesics and NSAIDs. If positive, these results could support regulatory approval and clinical integration of standardized cannabis extracts into evidence-based [pain management](https://cedclinic.com/cbd-cbg-topicals-for-eczema/) protocols, particularly for opioid-sparing alternatives. **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](https://cedclinic.com/cannabis-for-pain-relief/) 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 adds meaningful data to our limited evidence base for full-spectrum cannabis in chronic low back pain, showing efficacy in a reasonably sized population where conventional options often disappoint patients. However, several factors warrant cautious interpretation: the study appears incomplete in the available abstract, baseline pain severity and functional outcomes aren’t detailed, and we lack information on whether benefits persist beyond the open-label phase or how this extract compares directly to other [cannabinoid formulations](https://cedclinic.com/brazil-cannabis-regulatory-framework-new-medical-rules/) or multimodal approaches. The heterogeneity of cannabis products and individual patient responses means that even positive findings in a controlled trial may not directly predict outcomes in diverse clinical populations with varying comorbidities and concurrent medications. For now, if you’re considering recommending or discussing cannabis with CLBP patients, frame it as one option within a broader [pain management](https://cedclinic.com/cbd-cbg-topicals-for-eczema/) strategy, ensure clear documentation of the specific product and dosing, and establish realistic expectations that individual response varies considerably and long-term safety data in this indication remains limited. [Full Article](https://doi.org/10.1038/s41591-025-03977-0)  |  [PubMed](https://pubmed.ncbi.nlm.nih.gov/41023483/)  |  [PMC Full Text](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6553961/) Further Reading Cannabis News[Recreational drugs triple the risk of stroke in young people, study finds | The Independent](https://cedclinic.com/recreational-drugs-stroke-risk-young-adults-study/) Cannabis Memes[College is hard lmao](https://cedclinic.com/college-is-hard-lmao/) 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/) Further Reading CED Clinic Blog[Why Cannabis Works](https://cedclinic.com/why-cannabis-works/) CED Clinic Blog[Smart Cannabis Dosing](https://cedclinic.com/smart-cannabis-dosing/) CED Clinic Blog[Cannabis Product Guide](https://cedclinic.com/cannabis-product-guide/) [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 evaluating cannabis sativa extracts for chronic low back pain. [Read the full trial](https://cedclinic.com/phase-3-cannabis-trial-chronic-low-back-pain-results/) [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/) Insights into the endocannabinoid system's role in chronic low back pain from a phase 3 cannabis sativa extract trial. [Explore trial insights](https://cedclinic.com/phase-3-randomized-controlled-trial-chronic-low-back-pain/) [Endocannabinoid System Clinical Research: Cannabis Evidence](https://cedclinic.com/full-spectrum-cannabis-extract-pain-trial/) Comprehensive [clinical research](https://cedclinic.com/cannabis-based-therapies-smoking-cessation/) on cannabis and its effects on the [endocannabinoid system](https://cedclinic.com/endocannabinoid-system-fear-extinction/) in pain management. [Learn more about cannabis research](https://cedclinic.com/full-spectrum-cannabis-extract-pain-trial/) Have thoughts on this? 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