A new phase 3 clinical trial published in Nature Medicine has found that VER-01, a full-spectrum Cannabis sativa extract, significantly reduces pain and improves sleep and physical function in adults with chronic low back pain (CLBP) — without serious side effects or signs of addiction.
The study, involving over 800 participants with CLBP who had not responded adequately to nonopioid treatments, found that those taking VER-01 experienced clinically meaningful pain relief, better sleep, and improved physical ability. Notably, these benefits were sustained over time without dose escalation, and fewer patients required additional pain medications.
Lead investigator Dr. Matthias Karst (Hannover Medical School, Germany) emphasized that VER-01 also addresses two key comorbidities in CLBP — poor sleep and impaired function — without evidence of dependence or withdrawal.
In the double-blind, placebo-controlled trial:
- VER-01 reduced pain more than placebo (mean difference: -0.6 points; P < .001)
- In patients with neuropathic pain, the benefit was even greater (-1.5 points; P < .001)
- 54% of VER-01 users saw at least a 30% pain reduction vs. 40% with placebo
- Sleep and physical function also significantly improved
During the 6-month extension phase, nearly 75% achieved ≥30% pain reduction, with no signs of increasing tolerance. Adverse effects like dizziness and nausea were mild and transient. No serious safety concerns emerged.
Experts praised the trial’s rigorous design, filling a gap in research on standardized cannabis-based therapies. Dr. Samer Narouze (UH Cleveland Medical Center) called VER-01 “a nonaddictive, safe, and effective therapeutic alternative,” while UK neuroscientist Dr. Jan Vollert noted the study meets the high evidence standard long demanded in cannabis research.
The trial was sponsored by Vertanical, with independent data analysis. Further studies are recommended to confirm these promising results.
