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Health: Non-addictive cannabis extract reduces chronic back pain
The cannabis extract VER-01 is found to reduce chronic low back pain, without serious side effects or signs of addiction, according to a phase 3 clinical trial with over 800 people, published in Nature Medicine. This may be the first non-addictive and clinically proven chronic pain treatment based on the cannabis plant.
Chronic low back pain affects more than half a billion people worldwide, which makes it a leading cause of disability and lower quality of life. Yet treatment options remain limited to nonsteroidal anti-inflammatory drugs, which pose serious long-term cardiovascular and gastrointestinal risks, or opioids, which can have severe side effects and are highly addictive.
Mathias Karst and colleagues evaluated the safety and efficacy of VER-01, a full-spectrum extract of the cannabis sativa plant, in a phase 3 clinical trial. This involved 820 adults with chronic low back pain who had insufficient pain relief from non-opioid drugs. Participants who received VER-01 had a 1.9-point reduction in the pain numeric rating scale — a 0- to-10-point scale for patients to self-report their pain levels — after 12 weeks of treatment. This is compared with a 0.6-point reduction in pain for patients who received a placebo. Patients who received VER-01 experienced an additional decrease in pain of 1.1 numeric rating scale points in the subsequent 6-month extension to the study. VER-01 was relatively well tolerated, with the most common adverse events being short-term dizziness, excessive sleepiness (somnolence), and nausea during the early treatment phase. Furthermore, Karst and colleagues did not observe signs of dose escalation, abuse, dependence or withdrawal symptoms.
The findings highlight the ability of VER-01 to relieve pain without the addiction risks and harmful consequences often associated with opioids. Given the high prevalence of chronic low back pain and the global scale of the opioid crisis, these findings highlight a promising, non-addictive pain-management strategy for clinical use.
Expert Reaction
These comments have been collated by the Science Media Centre to provide a variety of expert perspectives on this issue. Feel free to use these quotes in your stories. Views expressed are the personal opinions of the experts named. They do not represent the views of the SMC or any other organisation unless specifically stated.
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, UK, 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.”
Dr Jan Vollert, Lecturer in Neuroscience, University of Exeter, UK, 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.”
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