For years, cannabis advocates have said the plant could be a safer alternative to opioids for chronic pain. Now, a Phase 3 clinical trial published in Nature Medicine gives that idea some of its strongest scientific backing yet.
The study tested VER-01, a standardized full-spectrum cannabis extract developed by German company Vertanical, in more than 800 patients with chronic low back pain. Results? Patients on VER-01 saw significantly greater pain reduction than those on placebo, along with better sleep and improved physical function.
The Study at a Glance
- Size: 820 participants across 66 sites in Germany and Austria
- Design: Randomized, double-blind, placebo-controlled, with open-label extensions
- Core finding: VER-01 reduced pain scores by −1.9 points on a 0–10 scale vs. −1.4 on placebo (p<0.001).
- Durability: Improvements continued over 6–12 months in the open-label phases.
- Extras: Patients reported less reliance on rescue meds, better sleep, and improved physical function.
The extract also showed pronounced benefits for patients with neuropathic pain and those with severe baseline pain.
Side effects were common—83% of VER-01 users reported at least one adverse event (vs. 67% on placebo)—but mostly mild and short-lived (dizziness, fatigue, nausea). About 17% discontinued due to side effects, mainly during the first three weeks of titration. Importantly, researchers found no evidence of dependence, withdrawal, or abuse.
Cannabis vs. Opioids
A companion Phase 3 study (published in Pain & Therapy) compared VER-01 directly to opioids in 384 patients. VER-01 came out ahead on pain reduction and had a much lower rate of opioid-style side effects like constipation. That’s a big deal in a field where long-term opioid use is increasingly discouraged.
The Catch
Not every test was a slam dunk. In a randomized withdrawal phase, VER-01 didn’t meet its primary endpoint of delaying “treatment failure” compared to placebo. Still, pain worsened more sharply in patients switched to placebo, suggesting the extract’s benefits didn’t vanish overnight.
Why It Matters
Chronic low back pain is the leading cause of disability worldwide, affecting more than half a billion people. Standard treatments—NSAIDs and opioids—carry well-known risks, from ulcers and heart problems to addiction and overdose. Cannabis-based medicines have been floated as an alternative, but most prior trials were small and inconsistent.
By contrast, this is a large, multicenter, rigorously blinded trial with standardized dosing and a well-characterized extract. For regulators in Europe and the U.S., this could mark the beginning of cannabis-based pain therapies moving from dispensaries and anecdotal reports into mainstream medicine.
Funding, Conflicts & More Details
- Sponsor: Trial sponsored by Vertanical GmbH.
- Independence: Stats run by Metronomia CRO; paper published in Nature Medicine.
- Funding: Open-access fees covered by Medizinische Hochschule Hannover (MHH).
- Conflicts: Several authors disclosed consultancy or institutional support from Vertanical and other pharma companies.
- Registration: ClinicalTrials.gov NCT04940741.
- Caveat: One withdrawal-phase endpoint not met; further U.S. Phase 3 planned for 2026.
Bottom line: A full-spectrum cannabis extract has cleared a large, blinded Phase 3 trial with results strong enough to rival opioids. The data isn’t perfect; but it’s a milestone moment for cannabis science.
Cover image made with AI
