Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial
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Unlabelled Patients with advanced cancer who have pain that responds poorly to opioid therapy pose a clinical challenge. Nabiximols (Nabiximols is the U.S. Adopted Name [USAN] for Sativex [GW Pharma Ltd, Wiltshire, U.K.], which does not yet have an INN), a novel cannabinoid formulation, is undergoing investigation as add-on therapy for this population. In a randomized, double-blind, placebo-controlled, graded-dose study, patients with advanced cancer and opioid-refractory pain received placebo or nabiximols at a low dose (1-4 sprays/day), medium dose (6-10 sprays/day), or high dose (11-16 sprays/day). Average pain, worst pain and sleep disruption were measured daily during 5 weeks of treatment; other questionnaires measured quality of life and mood. A total of 360 patients were randomized; 263 completed. There were no baseline differences across groups. The 30% responder rate primary analysis was not significant for nabiximols versus placebo (overall P = .59). A secondary continuous responder analysis of average daily pain from baseline to end of study demonstrated that the proportion of patients reporting analgesia was greater for nabiximols than placebo overall (P = .035), and specifically in the low-dose (P = .008) and medium-dose (P = .039) groups. In the low-dose group, results were similar for mean average pain (P = .006), mean worst pain (P = .011), and mean sleep disruption (P = .003). Other questionnaires showed no significant group differences. Adverse events were dose-related and only the high-dose group compared unfavorably with placebo. This study supports the efficacy and safety of nabiximols at the 2 lower-dose levels and provides important dose information for future trials.Perspective Nabiximols, a novel cannabinoid formulation, may be a useful add-on analgesic for patients with opioid-refractory cancer pain. A randomized, double-blind, placebo-controlled, graded-dose study demonstrated efficacy and safety at low and medium doses.
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Side effects such as nausea, drowsiness, and dizziness are more frequent with higher doses of cannabinoids.
“Side effects such as nausea, drowsiness, and dizziness are more frequent with higher doses of cannabinoids (Narang et al, 2008;Portenoy et al, 2012).”
From Opioid-Sparing Effect of Cannabinoids: A Systematic Review and Meta-Analysis (2017) · cites this paper as Portenoy et al, 2012
In Portenoy 2012, treatment difference (change from baseline pain score) for nabiximols 1-4 sprays was -0.75 points (95% CI -1.28, -0.22, p = 0.06 compared to placebo); for 6-10 sprays -0.36 points (95% CI -.089, 0.18 points, p = 0.19); for 11-16 sprays -0.09 points (95% CI: -0.62, 0.44 points, p = 0.75).
“Treatment difference (change from baseline pain score): -0.75 points (95% CI -1.28, -0.22, p = 0.06 compared to placebo)”
From Opioid-Sparing Effect of Cannabinoids: A Systematic Review and Meta-Analysis (2017) · cites this paper as Portenoy 2012
In Portenoy 2012, there was no change in median amount of breakthrough opioid medication in any group; patients were discouraged from reducing their opioid dose, so the opioid-sparing effect could not be observed.
“No change in median amount of breakthrough opioid medication in any group.Note that patients were discouraged from reducing their opioid dose, so the opioid-sparing effect could not be observed”
From Opioid-Sparing Effect of Cannabinoids: A Systematic Review and Meta-Analysis (2017) · cites this paper as Portenoy 2012
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- Authors
- Portenoy, R. K., Ganae-Motan, E. D., Allende, S., Yanagihara, R., Shaiova, L., Weinstein, S., McQuade, R., Wright, S., & Fallon, M. T.
- Affiliations
- Mount Sinai Beth Israel (US)
- Metropolitan Hospital Center (US)
- Huntsman Cancer Institute (US)
- Otsuka (United States) (US)
- GW Pharmaceuticals (United Kingdom) (GB)
- Edinburgh Cancer Research (GB)
- Corresponding author
- Portenoy, Russell K.
- Venue
- The Journal of Pain
- Publisher
- Elsevier BV
- Published
- 2012-05
- Volume
- 13
- Issue
- 5
- Pages
- 438-449
- ISSN
- 1526-5900 (ISSN-L)
- OpenAlex
- W2113421289
- Cited by
- 420
- References
- 34
- Citations by year
- 2026: 13 · 2025: 22 · 2024: 27 · 2023: 33 · 2022: 45 · 2021: 44 · 2020: 46 · 2019: 37 · 2018: 47 · 2017: 26 · 2016: 30 · 2015: 15 · 2014: 15 · 2013: 10 · 2012: 6
- FWCI
- 19.64
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Pain (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Huntsman Cancer Foundation
- GW Pharmaceuticals
- Topics
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Health Sciences › Medicine › Pharmacology › Cannabis and Cannabinoid Research
- Health Sciences › Medicine › Physiology › Pain Mechanisms and Treatments
- Keywords
- nabiximols, Sativex, cannabinoid therapy, advanced cancer, dose-response relationship, sleep disruption, quality of life, mood, adverse events
- MeSH terms
- Aged, Analgesics, Opioid, Cannabidiol, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Neoplasms, Pain Measurement, Dronabinol, Time Factors, Analgesics, Non-Narcotic, Chronic Pain
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