A major phase 3 clinical trial has found that a full-spectrum cannabis extract outperformed opioids in both safety and effectiveness for treating chronic low back pain. The trial is similar to, but separate from, a recent clinical trial published by Nature Medicine.
The study, published yesterday by the journal Pain and Therapy, involved 384 participants across Europe, randomized to receive either VER-01 (a full-spectrum cannabis extract) or standard opioid medications for six months.
Researchers note that chronic low back pain (CLBP)—persistent for more than three months—is among the world’s most-widespread causes of disability. Current pharmacologic therapies, such as NSAIDs and opioids, are limited by tolerance, adverse effects, and risks of dependence. In particular, opioid-induced constipation (OIC) affects 40–60% of patients under long-term opioid therapy, severely reducing quality of life and often forcing dose reductions or therapy discontinuation.
In the trial, participants receiving VER-01 were fourfold less likely to develop constipation compared to those on opioids. Only 5.8% of the VER-01 group required laxatives—versus 17.2% in the opioid arm—and laxative use in that group lasted a median of 6 days compared to 21 days in the opioid group.
Beyond gastrointestinal tolerability, VER-01 produced stronger and more consistent pain relief. Over 6 months, mean pain reduction was 2.50 points on an 11-point numeric rating scale (NRS) versus 2.16 points with opioids (mean difference 0.34; 95% CI 0.00–0.67; p = 0.048). Sleep interference due to pain improved by 2.52 points with VER-01 versus 2.07 with opioids (difference 0.45; 95% CI 0.11–0.79; p = 0.009). These benefits were especially evident in participants with severe pain or a neuropathic pain component.
Importantly, patients on VER-01 did not show signs of withdrawal or dependence. While those in the opioid arm required a tapering period to prevent withdrawal symptoms, the VER-01 group discontinued treatment abruptly without any reported withdrawal effects.
Notably, this Pain and Therapy trial comes just one day after another large clinical study reported by The Marijuana Herald that also demonstrated significant pain relief and functional improvements using the VER-01 formulation. That study, published by Nature Medicine, enrolled 820 patients in a double-blind, placebo-controlled design, showing that VER-01 reduced average pain more than placebo, improved sleep quality, and enhanced physical function over its open-label extension period—all with favorable safety and no signs of dependence—even after abrupt discontinuation. The consistency between the two studies strengthens the evidence that full spectrum cannabis extracts can offer a viable, non-addictive alternative to opioids for long-term chronic back pain management.
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