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This study was sponsored by GW Pharma Ltd (GW). GW was involved in the study design, data collection and analysis, as well as in the preparation of this manuscript and publication decisions.

M. Serpell, S. Ratcliffe, J. Hovorka, M. Schofield and E. Ehler were all investigators in this study and received investigator fees from GW accordingly for their participation in the study. GW medical writers L. Taylor and H. Lauder undertook the initial compilation and quality control review of the manuscript. Together with the other authors, the target journal was then agreed and all authors reviewed and contributed to the content of the manuscript, and agreed upon the final submitted version. All Intellectual Property Rights arising out of the current clinical study are vest in or exclusively licensed to GW.

Abstract

At the 30% responder level, there were statistically significant treatment differences in favour of THC/CBD spray in the full analysis (intention-to-treat) dataset [p = 0.034; 95% confidence interval (CI): 1.05–3.70]. There was also a reduction in mean PNP 0–10 NRS scores in both treatment groups that was numerically higher in the THC/CBD spray group, but which failed to reach statistical significance. Secondary measures of sleep quality 0–10 NRS score (p = 0.0072) and Subject Global Impression of Change (SGIC) (p = 0.023) also demonstrated statistically significant treatment differences in favour of THC/CBD spray treatment.

Peripheral neuropathic pain (PNP) associated with allodynia poses a significant clinical challenge. The efficacy of Δ 9 -tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray, a novel cannabinoid formulation, was investigated in this 15-week randomized, double-blind, placebo-controlled parallel group study.

Conflicts of interest:

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Disulfiram (Antabuse) might interact with marijuana. Taking marijuana along with Disulfiram can cause agitation, trouble sleeping, and irritability.