A large phase 3 clinical trial published in Nature Medicine has found that VER-01, a standardized full-spectrum cannabis extract, provides meaningful and sustained pain relief for adults with chronic low back pain (CLBP), while also improving sleep quality and physical function.

The study enrolled 820 adults across 66 sites in Germany and Austria. Participants were randomized to receive either VER-01 (n=394) or placebo (n=426) in a 12-week double-blind phase, followed by a 6-month open-label extension, and then either a 6-month continuation or randomized withdrawal. At baseline, patients reported moderate-to-severe pain, with an average numeric rating scale (NRS) score of around 6, and over 22% had a neuropathic pain component.

VER-01 met its primary endpoint in phase A, reducing mean pain by 1.9 NRS points versus 1.4 for placebo (mean difference −0.6; 95% CI −0.9 to −0.3; P<0.001). For those with neuropathic pain, the effect was more pronounced, with an additional reduction of −1.5 points. By the end of the open-label phase, pain decreased by nearly 3 points from baseline, with benefits maintained through 12 months. More than half (54%) of VER-01 participants achieved at least a 30% reduction in pain compared to 40% in placebo, while 32% reached a 50% reduction versus 23% in placebo.

Improvements extended beyond pain. Sleep quality scores improved significantly (−2.2 versus −1.5 NRS points, P<0.001), and physical function measured by the Roland Morris Disability Questionnaire also favored VER-01 (−3.1 versus −2.0 points, P<0.001). Over 45% of patients reported meaningful global improvement, double the placebo rate. Rescue medication use was nearly halved in the VER-01 group, with participants averaging 10.5 ibuprofen tablets compared to 18.3 for placebo.

Safety data showed VER-01 was generally well-tolerated. While adverse events were more common than placebo (83% versus 67%), most were mild to moderate and transient, with dizziness, fatigue, nausea, dry mouth, and somnolence being the most frequent. Serious adverse event rates were comparable between groups (6.2% vs 6.8%). Importantly, there were no signs of dependence, abuse, or withdrawal symptoms during abrupt discontinuation.

The trial highlights VER-01’s potential as a safe, nonaddictive alternative to NSAIDs and opioids, which carry significant risks in long-term CLBP treatment. With an NNTB (number needed to treat for benefit) of 6.8 for a 30% pain reduction, VER-01 performed more favorably than opioids in similar trials.

Researchers emphasized that VER-01’s standardized formulation—characterized for cannabinoids, terpenes, flavonoids, and other compounds—ensures consistency often lacking in cannabis-based products. They concluded that VER-01 may represent a meaningful advance in chronic pain management, addressing not only pain but also the associated disability and sleep disturbances that compound CLBP’s global burden.