# VER-01 Cannabis Extract: Phase 3 Trial for Chronic 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/ver-01-cannabis-extract-clinical-trial-chronic-back-pain/ > **Published:** 2026-03-03T20:36:17-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T12:01:16-04:00 > **Clinical Summary:** Explore the VER-01 cannabis extract clinical trial results for chronic back pain, highlighting safety and efficacy in a large phase 3 study. --- #### Clinical Takeaway In this phase 3 randomized controlled trial, 820 adults with chronic low back pain received either VER-01, a full-spectrum cannabis extract, or placebo over a 12-week double-blind period, with extensions lasting up to an additional year. The trial was designed to assess both efficacy and safety at a scale and duration rarely seen in [cannabis medicine](https://cedclinic.com/essential-oils-industrial-hemp-antimicrobial-benefits/) research. Results from this large, well-controlled study add meaningful clinical evidence to the conversation about cannabis-based options for patients whose pain is inadequately managed by 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 significant clinical gap by providing rigorous evidence for cannabis-based therapy in chronic low back pain, a condition affecting over 500 million people globally where current pharmaceutical options demonstrate limited efficacy and considerable adverse effect profiles. The large sample size (820 participants) and double-blind design strengthen the validity of findings regarding VER-01’s efficacy and safety profile, potentially offering clinicians a new evidence-based treatment option for patients who fail or cannot tolerate conventional analgesics. If positive results are demonstrated, this research could establish cannabis full-spectrum extract as a legitimate therapeutic alternative for CLBP management within standard clinical practice. **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 of a full-spectrum cannabis extract for chronic low back pain addresses a genuine clinical need, given that current pharmacotherapies often provide inadequate relief with unfavorable risk profiles. The study’s substantial sample size and double-blind design strengthen confidence in the findings, though the abstract excerpt provided is incomplete, leaving critical details about efficacy outcomes, effect sizes, and safety signals unavailable for full assessment. Key considerations for clinical application include whether observed benefits exceed those of conventional analgesics, the relevance of the specific cultivar and extraction method to commercially available products, potential confounders such as baseline pain severity or concurrent treatments, and whether symptom improvement persists in the open-label extension or reflects expectancy effects. Until the full results are published and critically reviewed, clinicians should view this as promising preliminary evidence rather than definitive practice guidance. For now, [cannabis-based medicine](https://cedclinic.com/former-nfl-quarterback-urges-athletes-to-consider-cbd-products/) for CLBP remains a reasonable consideration in patients who have exhausted or cannot tolerate first-line therapies, though informed consent should emphasize [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 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[Cannabis for Sleep](https://cedclinic.com/cannabis-for-sleep/) [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 [Clinical Research on Full-Spectrum Cannabis Extract VER-01 for Back Pain](https://cedclinic.com/full-spectrum-cannabis-extract-ver-01-back-pain-trial/) Detailed [clinical research](https://cedclinic.com/cannabis-based-therapies-smoking-cessation/) on the VER-01 full-spectrum cannabis extract trial for chronic back pain, including methodology and outcomes. [Read the full study](https://cedclinic.com/full-spectrum-cannabis-extract-ver-01-back-pain-trial/) [Endocannabinoid System: Phase 3 Cannabis Trial for Back Pain](https://cedclinic.com/full-spectrum-cannabis-extract-ver-01-back-pain-trial/) Explore the phase 3 cannabis trial focused on the endocannabinoid system's role in managing chronic back pain. [Learn more](https://cedclinic.com/full-spectrum-cannabis-extract-ver-01-back-pain-trial/) [Endocannabinoid System Clinical Research: Phase 3 Cannabis Trial Results](https://cedclinic.com/phase-3-cannabis-trial-chronic-low-back-pain-results/) Comprehensive results from a phase 3 cannabis trial investigating chronic low back pain and [endocannabinoid system](https://cedclinic.com/endocannabinoid-system-fear-extinction/) interactions. [View results](https://cedclinic.com/phase-3-cannabis-trial-chronic-low-back-pain-results/) Have thoughts on this? 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