By Tarun Sai LomteReviewed by Susha Cheriyedath, M.Sc.Sep 30 2025

A large European trial shows that VER-01, a full-spectrum Cannabis sativa extract, delivers meaningful pain relief and lasting improvements in sleep and physical function for people with chronic low back pain.

Study: Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial. Image Credit: Jo Panuwat D / Shutterstock

In a recent study published in the journal Nature Medicine, researchers investigated the safety and efficacy of a Cannabis sativa extract (VER-01) in the treatment of chronic low back pain (CLBP).

Low back pain is the leading cause of work loss, reduced quality of life, and disability worldwide. It is defined as CLBP when pain lingers for over three months. CLBP is often associated with impairments in physical function and sleep quality. Pharmacological treatment includes non-steroidal anti-inflammatory drugs, which are not suitable over the long term due to adverse effects (AEs). Opioids are often used for long-term therapy despite safety concerns and AEs.

However, several guidelines advise against opioid use, and there is consensus among regulators, healthcare professionals, and patient organizations on the pressing need for non-addictive analgesics with a better safety profile. Cannabis-based medications have gained substantial interest for managing chronic pain. Nevertheless, the quality of evidence on the clinical use of these products is low.

About the study

In the present study, researchers investigated the safety and efficacy of VER-01 in CLBP. This randomized, placebo-controlled trial was conducted in Austria and Germany, comprising a 12-week treatment phase (phase A), a six-month extension phase (phase B), followed by a six-month continuation phase (phase C) or withdrawal phase (phase D). Adults aged ≥ 18 diagnosed with CLBP with or without a neuropathic pain component were enrolled.

VER-01 was a standardized full-spectrum extract of a patented C. sativa L. strain DKJ127. Each VER-01 dose delivered 2.5 mg tetrahydrocannabinol, 0.02 mg cannabidiol, and 0.1 mg cannabigerol. In addition, VER-01 contained a mixture of carotenes, terpenes, phytosterols, and flavonoids, among others. The placebo consisted of sesame oil, colorants, and cannabis aroma. Participants were asked to take the study drug with or without food.

Intake of analgesics other than rescue medication (ibuprofen) or paracetamol if ibuprofen was contraindicated, per protocol limits were prohibited during phases A and D, and the last three weeks of phase B. Participants recorded their pain intensity, sleep quality, dosage, and use of rescue medication. The primary endpoint of phase A was the change in the average weekly pain intensity from baseline to week 15, measured on an 11-point numeric rating scale. No primary endpoints were defined for phases B and C, although multiple secondary outcomes were collected.

The primary endpoint in Phase D was the time to treatment failure, defined as a> 1-point increase in the seven-day average of pain intensity and a≥20% increase compared to the Phase D baseline. Various secondary endpoints were also assessed in phases A and D. Safety was evaluated based on AE incidence, including severity and relationship to the study drug. Further, patients’ satisfaction with tolerability was examined.

Findings

In total, 820 patients were randomized to VER-01 or placebo; of these, 525, 155, and 116 continued to phases B, C, and D, respectively. On average, participants were aged 52 years and had a body mass index (BMI) of 29 kg/m². Around 22% had a neuropathic pain component, and 23.5% had severe pain at baseline. Hypertension and obesity were the most common concurrent diseases. Pain intensity was moderate to severe at baseline in both groups.

The study met its phase A primary endpoint. The average pain intensity significantly reduced by 1.9 points from baseline in the VER-01 group compared to the placebo group. VER-01 demonstrated a greater pain reduction than the placebo, with a mean difference of -0.6 points. In participants with a neuropathic pain component, the between-group difference was larger. Phase A secondary endpoints were also met, with significant improvements in neuropathic symptoms.

The rates of participants with ≥ 30%, ≥ 50%, and ≥ two-point pain reductions were significantly higher in the VER-01 arm than in the placebo arm. The VER-01 group also showed significant improvements in physical function and sleep quality. Further, these improvements were associated with a positive global impression of change and a higher quality of life. The number needed to treat for a 30% pain response was 6.8. Pain intensity was further reduced during phase B, decreasing by three points compared to the baseline of phase A.

Phase B subjects who participated in phase C maintained pain reduction, with no signs of diminishing efficacy or dose escalation over time. In phase D, the time to treatment failure was not significantly different between groups (hazard ratio, 0.75; P = 0.288; median, 22 vs 11 days for VER-01 and placebo). However, placebo subjects experienced a significant increase in pain from phase D baseline following withdrawal. Treatment-emerged AEs in phase A were reported by 83% of VER-01 participants compared to 67% of placebo subjects, and AE-related discontinuation occurred in 17.3% with VER-01 versus 3.5% with placebo. Most adverse events were mild to moderate and transient, with incidence declining after the initial titration period.

The rate of serious AEs was comparable between groups. No deaths occurred throughout the study. There was no evidence of abuse, dependence, or withdrawal, including after abrupt discontinuation. Additionally, there were no clinically significant treatment-related changes in vital signs, electrocardiograms, or clinical laboratory parameters for VER-01 compared to placebo. Satisfaction with tolerability was 68% for VER-01 at the end of Phase A, increasing to 83% and 84% by the end of Phases B and C, respectively.

Conclusions

VER-01 provided meaningful pain reduction and improved sleep quality and physical function. The VER-01 group also had substantially lower use of rescue medication. Prolonged VER-01 treatment was associated with continued improvements in pain reduction, physical function, quality of life, and sleep quality.

Overall, the findings provide robust evidence supporting the safety and efficacy of VER-01 in CLBP treatment. Key limitations include the absence of a formal blinding assessment, no cognitive testing, and a nonsignificant primary endpoint in randomized withdrawal despite greater pain increase with placebo after withdrawal.