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Results from a phase 3 randomised controlled trial looks at the use of cannabis extract VER-01 for chronic lower back pain.
Dr Jan Vollert, Lecturer in Neuroscience, University of Exeter, said:
“This is an excellent study. We have long argued that studies on cannabis or cannabis-based substances need to provide high level of evidence: this is it. It is only one trial, and we will need further studies to confirm the findings, but this is a good signal that the compound could help patients. Previous studies have found mixed results with other compounds, and most were not of great quality, so this is a very clear step in the right direction.
“The pain relief was clinically significant and would be meaningful to the many people living with chronic pain out there. In the open label phase, the pain relief was much higher, showing why well-conducted, double-blind trials are so important. The randomized withdrawal (phase D) was not significant, which is interesting and shows that more studies should be conducted to see if the main outcome (phase A) can be sustained.
“This is a very specific substance, provided in a controlled manner. This is in no way comparable to smoking cannabis. While there are many stories of people reporting their pain gets better from consuming cannabis, we have not been able to underpin that with good evidence. To me, this study does not make a case for smoking cannabis, as smoking cannabis and taking VER-01 are probably as similar as eating hazelnuts and eating Nutella: they might share a similar basis, but they just are not comparable.”
Prof David Nutt, The Edmond J Safra Chair and Head of the Centre for Neuropsychopharmacology, Division of Brain Sciences, Dept of Medicine, Imperial College London, said:
“This is an elegant study using a placebo design with later cross over from placebo to active that confirms what we at DrugScience and other have been saying for some time based on our T21 initiative and Multi-Criteria Decision Analysis – that whole plant extract cannabis-based products have a role in chronic pain treatment.
“Let’s hope that new research helps encourage a more rational approach to medical cannabis prescribing in the NHIS where still, after nearly 7 years of it being approved for use, there are less than 10 scripts on the NHS. Chronic pain patients are therefore required to pay privately which, given they are often not able to work due to their condition, can be impossible.
“There is also evidence from T21 research that medical cannabis can help people reduce use of harmful painkillers like opiates.”
Project T21 – https://www.drugscience.org.uk/t21
‘Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial’ by Matthias Karst et al. was published in Nature Medicine at 16:00 UK time on Monday 29th September.
DOI: https://doi.org/10.1038/s41591-025-03977-0
Declared interests
Dr Jan Vollert: I was not involved in the study, and have no conflict of interest, but I do work with the pharmaceutical industry, with unrelated companies, on unrelated studies. My full interests of the last years are:
Prof David Nutt: DJN is chair of the scientific committee of charity DrugScience that ran the T21 medical cannabis initiative and receives unrestricted educational grants from some cannabis companies