# Cannabis Sativa Extracts Efficacy in Chronic Low Back Pain: A Phase 3 Trial

> **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637)
> **Publisher:** CED Clinic (https://cedclinic.com)
> **Canonical URL:** https://cedclinic.com/cannabis-sativa-extracts-efficacy-in-chronic-low-back-pain-a-phase-3-trial/
> **Published:** 2026-09-07T22:18:32-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T10:45:15-04:00
> **Clinical Summary:** Chronic Low Back Pain Treatment: Efficacy & Safety of Full-Spectrum Cannabis Extract VER-01 in Phase 3 Trial

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Table of Contents

- [Clinical Takeaway](#Clinical_Takeaway)
- [#2 Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial.](#2_Full-spectrum_extract_from_Cannabis_sativa_DKJ127_for_chronic_low_back_pain_a_phase_3_randomized_placebo-controlled_trial)
- [What This Study Teaches Us](#What_This_Study_Teaches_Us)
- [Why This Matters Clinically](#Why_This_Matters_Clinically)
- [Study Snapshot](#Study_Snapshot)
- [Where This Paper Deserves Skepticism](#Where_This_Paper_Deserves_Skepticism)
- [Dr. Caplan’s Take](#Dr_Caplan8217s_Take)
- [Clinical Bottom Line](#Clinical_Bottom_Line)
- [Related](#Related)

#### Clinical Takeaway

VER-01, a full-spectrum extract from Cannabis sativa DKJ127, demonstrated efficacy and safety in treating chronic low back pain compared to placebo. The study showed significant improvements in pain relief and functional outcomes without major adverse effects.

### #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

**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 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 

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### Verification & Medical Governance

- **Lead Clinical Author:** Benjamin Caplan, MD
- **Credentials:** Board Certified in Family Medicine (ABFM), Former CMO Canna Care Docs (250,000+ patients supervised), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House).
- **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`).
- **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/).
- **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637).
- **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).