Full-Spectrum Cannabis Extract Shows Significant Pain Reduction in Chronic Low Back Pain: Phase 3 Trial

While chronic low back pain (CLBP) remains the primary global cause of disability and reduced quality of life, current reliance on nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids is severely limited by risks of gastrointestinal bleeding and the ongoing addiction crisis. To address this critical clinical gap, Matthias Karst from the Hannover Medical School and his colleagues aimed to evaluate whether the full-spectrum extract, VER-01, could serve as a nonaddictive, safe, and effective long-term therapeutic option.

For this purpose, the multicenter trial enrolled 820 adults across 66 outpatient and hospital sites in Germany and Austria. Participants were randomized to receive VER-01 or a placebo during a 12-week double-blind treatment phase. The primary endpoint was the change in mean morning pain intensity on the 11-point Numeric Rating Scale (NRS). Secondary outcomes included Neuropathic Pain Symptom Inventory (NPSI) scores in patients with a neuropathic pain component. Statistical analyses incorporated covariance modeling and multiple imputation to strengthen robustness. Individuals with identifiable treatable somatic causes or substance use disorders were excluded.

Key Clinical Findings of the Trial Include:

• Significant Analgesia: The trial demonstrated a notable mean pain decrease of -1.9 points on the 11-point scale compared to the -1.4 reduction observed in the control group.
• High Responder Rates: Success was evident as the investigation found 54.1% of participants achieved at least a 30% reduction in pain, a rate significantly higher than the 39.5% seen in the placebo arm.
• Neuropathic Efficacy: For patients with nerve-related symptoms, the research recorded a substantial NPSI total score drop of -14.4 points, doubling the relief reported by those receiving the placebo.
• Quality of Life: Clinical gains extended beyond physical discomfort, as the study reported participants experienced sleep quality improvements of -2.2 points alongside significant advancements in physical health component summary scores.
• Favorable Safety: Research confirmed that the extract was well-tolerated with no signals of drug dependence or withdrawal, and while adverse events like dizziness occurred more frequently, they were primarily mild and transient.

The results suggest that the standardized cannabis extract is a safe and potent treatment for persistent back issues, as evidenced by a significant 1.9-point drop in pain levels and a 54.1% success rate in achieving clinically relevant relief.

The study concludes that the medical professionals may find it helpful to inform patients that mild, passing side effects such as lightheadedness or fatigue might occur during the first few weeks of dose titration to encourage continued participation in the treatment plan.

Although the trial did not specifically measure changes in cognitive ability or directly compare the extract to traditional opioid therapies, there is an inviting opportunity for subsequent investigations to determine if these beneficial outcomes can be replicated across a broader range of chronic pain syndromes.

Reference

Karst, M., Meissner, W., Sator, S., Keßler, J., Schoder, V., & Häuser, W. (2025). Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial. Nature Medicine. https://doi.org/10.1038/s41591-025-03977-0