# Endocannabinoid System Clinical Research: Pain Management Trial

> **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-pain-trial/
> **Published:** 2026-04-25T23:07:57-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T11:54:45-04:00
> **Clinical Summary:** Explore the full-spectrum cannabis extract pain trial showing significant relief in chronic low back pain with VER-01 in a phase 3 clinical study.

---

#### Clinical Takeaway

VER-01, a full-spectrum cannabis extract, demonstrated statistically significant pain reduction compared to placebo in adults with chronic [low back pain](https://cedclinic.com/dronabinol-placebo-controlled-trial-chronic-pain/) over 12 weeks of treatment. Safety monitoring showed the medication was well-tolerated with manageable adverse effects across the extended study phases. These findings support full-spectrum cannabis extracts as a potential evidence-based option for patients with chronic low back pain who have inadequate response to or cannot tolerate 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

**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 

---

### 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).