Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THCCBD extract and THC extract in patients with intractable cancer-related pain.
This study compared the efficacy of a tetrahydrocannabinolcannabidiol (THCCBD) extract, a nonopioid analgesic endocannabinoid system modulator, and a THC extract, with placebo, in relieving pain in patients with advanced cancer. In total, 177 patients with cancer pain, who experienced inadequate analgesia despite chronic opioid dosing, entered a two-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial. Patients were randomized to THCCBD extract (n 60), THC extract (n 58), or placebo (n 59). The primary analysis of change from baseline in mean pain Numerical Rating Scale (NRS) score was statistically significantly in favor of THCCBD compared with placebo (improvement of -1.37 vs. -0.69), whereas the THC group showed a nonsignificant change (-1.01 vs. -0.69). Twice as many patients taking THCCBD showed a reduction of more than 30% from baseline pain NRS score when compared with placebo (23 43% vs. 12 21%). The associated odds ratio was statistically significant, whereas the number of THC group responders was similar to placebo (12 23% vs. 12 21%) and did not reach statistical significance. There was no change from baseline in median dose of opioid background medication or mean number of doses of breakthrough medication across treatment groups. No significant group differences were found in the NRS sleep quality or nausea scores or the pain control assessment. However, the results from the European Organisation for Research and Treatment of Cancer Quality of Life Cancer Questionnaire showed a worsening in nausea and vomiting with THCCBD compared with placebo (P 0.02), whereas THC had no difference (P 1.0). Most drug-related adverse events were mildmoderate in severity. This study shows that THCCBD extract is efficacious for relief of pain in patients with advanced cancer pain not fully relieved by strong opioids.