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Cited by 420Pain Management and Opioid UseCannabis and Cannabinoid ResearchPain Mechanisms and Treatments

The DOI matches its Crossref record; 33 of the 34 references it cites were found in a registry or an index.

Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial

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Portenoy, Russell K., Ganae-Motan, Elena Doina, Allende, Silvia, Yanagihara, Ronald, Shaiova, Lauren, Weinstein, Sharon, McQuade, Robert, Wright, Stephen, Fallon, Marie T.·2012·The Journal of Pain
DOI 10.1016/j.jpain.2012.01.003
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Abstract

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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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.
ORCID
Venue
The Journal of Pain
Publisher
Elsevier BV
Published
2012-05
Volume
13
Issue
5
Pages
438-449
ISSN
1526-5900 (ISSN-L)
DOI
10.1016/j.jpain.2012.01.003
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
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 (medical) › Cannabis and Cannabinoid Research
  • Health Sciences › Medicine › Physiology (medical) › 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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