A full-spectrum cannabis extract is effective at treating chronic low back pain, according to the results of a major clinical trial.
The phase 3 trial, published in the journal Nature Medicine, evaluated VER-01 – a full-spectrum extract from Cannabis sativa – in 820 adults suffering from chronic lower back pain. The study found that patients receiving VER-01 experienced meaningful pain reduction compared to placebo, alongside improvements in sleep quality and physical function.
“This is an excellent study,” said Dr Jan Vollert, Lecturer in Neuroscience at the University of Exeter. “We have long argued that studies on cannabis or cannabis-based substances need to provide high level of evidence: this is it.”
VER-01 patients reported an average pain reduction of 1.9 points on an 11-point scale, compared to 1.4 points for those taking a placebo. More than half (54.1%) of patients taking VER-01 achieved at least a 30% reduction in pain, versus 39.5% in the placebo group.
Lead researcher Professor Matthias Karst from Hannover Medical School and colleagues designed the comprehensive multi-phase trial to address longstanding questions about cannabis-based medicines in pain management. The study included a 12-week double-blind phase followed by open-label extension periods lasting up to 18 months.
Chronic low back pain affects over half a billion people globally and represents the leading cause of disability worldwide. Current treatment options remain limited, with NSAIDs such as ibuprofen unsuitable for long-term use due to cardiovascular and gastrointestinal risks, whilst opioids carry significant addiction potential.
The trial specifically addressed these concerns. “VER-01 was well-tolerated, with no signs of dependence or withdrawal,” the researchers reported. Most side effects were mild to moderate, including dizziness and dry mouth, and typically resolved within days of starting treatment.
Professor David Nutt from Imperial College London emphasised the broader impact of the positive results. “This elegant study… confirms what we at DrugScience and others have been saying for some time based on our T21 initiative… that whole plant extract cannabis-based products have a role in chronic pain treatment.”
The standardised extract contains precisely measured amounts of tetrahydrocannabinol (THC) and other cannabis compounds, delivered orally in controlled doses. Each dose unit contains 2.5mg THC along with other cannabinoids and terpenes.
Patients in the trial required significantly less additional medication, with VER-01 users taking approximately half the amount of ibuprofen compared to the placebo group. Additionally, 45.1% of VER-01 patients reported overall improvement in their condition, compared to 23.4% on placebo.
The research addresses a critical gap in cannabis medicine evidence. Previous studies have suffered from small sample sizes, inconsistent dosing, and varying preparations. This trial’s rigorous design and substantial participant numbers provide the robust evidence base that regulators and clinicians require.
Professor Nutt highlighted the accessibility challenges facing UK patients: “Let’s hope that new research helps encourage a more rational approach to medical cannabis prescribing in the NHS where still, after nearly seven years of it being approved for use, there are less than 10 scripts on the NHS.”
The findings are particularly significant given the global opioid crisis. With approximately 20% of chronic pain patients on long-term opioid therapy experiencing abuse or dependence issues, the need for safer alternatives has never been more urgent.
While the primary 12-week phase showed clear benefits, a withdrawal phase of the study did not reach statistical significance, suggesting more research is needed to understand long-term effects. The researchers noted that pain increased more in placebo patients upon withdrawal, indicating sustained benefit from VER-01.
The trial was conducted across 66 sites in Germany and Austria between July 2021 and March 2024. Vertanical, the study sponsor, plans to seek regulatory approval based on these results.
As chronic pain management continues to challenge healthcare systems worldwide, this research offers hope for a new therapeutic option. However, experts caution that VER-01 represents just one carefully developed product, and broader conclusions about cannabis-based medicines await further studies.
“It is only one trial, and we will need further studies to confirm the findings,” Dr Vollert noted, “but this is a good signal that the compound could help patients.”
