# Clinical Research on Full-Spectrum Cannabis Extract VER-01 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-ver-01-back-pain-trial/ > **Published:** 2026-04-15T13:51:48-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T11:01:36-04:00 > **Clinical Summary:** Explore the phase 3 clinical trial results of full-spectrum cannabis extract VER-01 for chronic low back pain, highlighting safety and efficacy. --- #### Clinical Takeaway In this phase 3 randomized controlled trial, 820 adults with chronic [low back pain](https://cedclinic.com/dronabinol-placebo-controlled-trial-chronic-pain/) received either VER-01, a full-spectrum [cannabis extract](https://cedclinic.com/experimental-cannabis-extract-chronic-back-pain-trial/), or placebo over 12 weeks, with extensions up to approximately one year. The trial was designed to generate high-quality evidence on both efficacy and safety in a condition where existing medications frequently fall short. Results from this large, well-structured study will help clarify whether full-spectrum cannabis preparations represent a viable clinical option for patients with chronic low back pain who have not responded adequately to conventional treatments. ### #1 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 evaluating a full-spectrum cannabis extract as a potential alternative to opioids and NSAIDs for chronic low back pain, a condition affecting over 500 million people globally with inadequate current treatment options. The rigorous double-blind, placebo-controlled design with 820 participants provides robust evidence needed to establish whether [cannabis-derived therapeutics](https://cedclinic.com/cannabis-related-regulatory-documents-dea/) can offer efficacy and safety advantages over existing pharmacologic approaches for CLBP management. **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 demonstrates that full-spectrum cannabis extract VER-01 shows meaningful efficacy for chronic low back pain in a reasonably sized population, addressing a genuine clinical need given the limitations of conventional analgesics. However, practitioners should note several important caveats: the study population likely represents a selected group willing to enroll in [cannabis research](https://cedclinic.com/pediatric-cannabis-certification-care-children/), the 12-week primary phase may not capture longer-term efficacy or tolerance patterns (particularly given the 6-month open-label extension), and full-spectrum extracts contain variable cannabinoid and terpene profiles that complicate standardization and reproducibility across different products. The safety profile and comparison to standard-of-care interventions like physical therapy or multimodal approaches remain key questions for clinical decision-making. For appropriate patients with CLBP who have failed or cannot tolerate conventional treatments, this evidence provides support for considering standardized full-spectrum cannabis extracts as part of an integrated [pain management](https://cedclinic.com/cbd-cbg-topicals-for-eczema/) plan, though clinicians should counsel patients on the still-evol  |   |  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/) Further Reading CED Clinic Blog[Why Cannabis Works](https://cedclinic.com/why-cannabis-works/) Evidence Watch[Cannabis and Heart Health](https://cedclinic.com/cannabis-cardiovascular-health-study/) CED Clinic Blog[Smart Cannabis Dosing](https://cedclinic.com/smart-cannabis-dosing/) [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 [Endocannabinoid System Clinical Research: Phase 3 Cannabis Trial Results](https://cedclinic.com/phase-3-cannabis-trial-chronic-low-back-pain-results/) Detailed results from the phase 3 cannabis trial focusing on chronic low back pain, providing insights into efficacy and safety outcomes. [Read the full study](https://cedclinic.com/phase-3-cannabis-trial-chronic-low-back-pain-results/) [Clinical Research on Full-Spectrum Cannabis Extract VER-01 for Back Pain](https://cedclinic.com/full-spectrum-cannabis-extract-ver-01-back-pain-trial/) An in-depth [clinical research](https://cedclinic.com/cannabis-based-therapies-smoking-cessation/) article on the use of full-spectrum cannabis extract VER-01 for managing chronic back pain. [Explore clinical insights](https://cedclinic.com/full-spectrum-cannabis-extract-ver-01-back-pain-trial/) [Endocannabinoid System RCT: Cannabis for Chronic Back Pain](https://cedclinic.com/full-spectrum-cannabis-extract-ver-01-back-pain-trial/) Randomized controlled trial data on full-spectrum cannabis extract VER-01 for chronic back pain, highlighting clinical efficacy and safety. [View trial data](https://cedclinic.com/full-spectrum-cannabis-extract-ver-01-back-pain-trial/) Have thoughts on this? 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