# Endocannabinoid System & Chronic Low Back Pain: Phase 3 Trial Results on Cannabis Sativa Extracts

> **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-randomized-controlled-trial-chronic-low-back-pain/
> **Published:** 2026-05-05T09:23:35-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T11:54:30-04:00
> **Clinical Summary:** Explore phase 3 randomized controlled trial chronic low back pain results with cannabis sativa extracts, highlighting clinical evidence and safety.

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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

In this phase 3 randomized controlled trial of 820 adults, the full-spectrum cannabis extract VER-01 was evaluated against placebo over 12 weeks for chronic [low back pain](https://cedclinic.com/dronabinol-placebo-controlled-trial-chronic-pain/), with extended follow-up reaching 15 months. The trial used a rigorous withdrawal design to assess durability of effect, addressing a condition where current medications frequently fall short. Results from this study contribute high-quality clinical evidence to the growing body of research on cannabinoid-based treatment for one of the most prevalent and burdensome pain conditions globally.

### #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](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 

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### Verification & Medical Governance

- **Lead Clinical Author:** Benjamin Caplan, MD
- **Credentials:** Board Certified in Family Medicine (ABFM), 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).