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Promising Results from Clinical Trial of Cannabis Extract for Chronic Low Back Pain

10/2/2025, 10:29:54 AM

Overview of the Clinical Trial

A recent large-scale clinical trial has demonstrated that a standardized, full-spectrum cannabis extract, known as VER-01, can effectively alleviate chronic low back pain (CLBP). Conducted by researchers led by Matthias Karst at Hannover Medical School, the study involved 820 adults suffering from CLBP, with participants randomly assigned to receive either VER-01 or a placebo over a 12-week period. The findings, published in *Nature Medicine*, indicate that VER-01 significantly reduced pain levels and improved physical function and sleep quality without leading to dependence or withdrawal symptoms.

Key Findings

During the initial 12-week double-blind phase, participants taking VER-01 reported an average pain reduction of 1.9 points on a 10-point scale, compared to a 1.4-point reduction in the placebo group. Notably, those with severe or nerve-related pain experienced the most significant benefits. The trial also included a long-term open-label extension, where participants continued using VER-01 for an additional six to twelve months, resulting in sustained pain relief and no signs of tolerance development.

Safety and Side Effects

While adverse events were more common among participants taking VER-01, these were predominantly mild to moderate, including dizziness, headache, and nausea. Most side effects occurred early in the treatment and diminished over time. Importantly, the study found no evidence of drug abuse or dependence, even after abrupt cessation of the treatment.

Expert Perspectives

Experts have praised the study for its rigorous design and the quality of evidence it provides regarding cannabis-based treatments. Jan Vollert from the University of Exeter noted that this trial sets a high standard for cannabis research, emphasizing that it should not be equated with smoking cannabis. David Nutt from Imperial College London highlighted the study's confirmation of the therapeutic role of whole plant extract cannabis products in chronic pain management.

Criticism and Limitations

Despite the positive outcomes, some experts caution that further research is necessary to validate these findings. The study did not compare VER-01 directly with other pain medications, such as opioids, and the withdrawal phase did not yield statistically significant results, suggesting a need for larger sample sizes in future trials. Additionally, the National Institute for Health and Care Excellence and the Scottish Intercollegiate Guidelines Network have previously expressed reservations about the routine use of cannabis-based products for chronic pain, citing limited evidence of significant improvements.

What's Next

Following the promising results, Vertanical, the manufacturer of VER-01, has filed for regulatory approval in Europe and is collaborating with the FDA to design further clinical trials in the United States. If successful, VER-01 could become one of the first widely prescribed cannabinoid-based medications for chronic back pain, offering a new avenue for patients seeking alternatives to traditional pain management methods.