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Nabiximols for Opioid-Treated Cancer Patients With Poorly-Controlled Chronic Pain: A Randomized, Placebo-Controlled, Graded-Dose Trial
Open accessAbstract
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 (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 the citing paper
“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 the citing paper
“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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Cites
Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., Filiberti, A., Flechtner, H., Fleishman, S. B., Haes, J. C. J. M. D., et al. (1993) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/85.5.365 · Cited by 16,005
A new depression scale designed to be sensitive to change
Montgomery, S. A., & Åsberg, M. (1979) · British Journal of Psychiatry · doi:10.1192/bjp.134.4.382 · Cited by 13,962
Opioid Complications and Side Effects
Benyamin, R. M. (2008) · Pain Physician · doi:10.36076/ppj.2008/11/s105 · Cited by 2,272
Oxford Textbook of Palliative Medicine
(2009) · Oxford University Press eBooks · doi:10.1093/med/9780198570295.001.0001 · Cited by 1,922
Salaffi, F., Stancati, A., Silvestri, C. A., Ciapetti, A., & Grassi, W. (2003) · European Journal of Pain · doi:10.1016/j.ejpain.2003.09.004 · Cited by 1,735
Bonica, J. J. (1954) · The American Journal of the Medical Sciences · doi:10.1097/00000441-195405000-00015 · Cited by 1,467
Portenoy, R. K., & Lesage, P. (1999) · The Lancet · doi:10.1016/s0140-6736(99)01310-0 · Cited by 1,013
Self-citationCannabinoid pharmacology: the first 66 years
Pertwee, R. G. (2006) · British Journal of Pharmacology · doi:10.1038/sj.bjp.0706406 · Cited by 783
Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis
Rog, D. J., Nurmikko, T. J., Friede, T., & Young, C. A. (2005) · Neurology · doi:10.1212/01.wnl.0000176753.45410.8b · Cited by 679
Johnson, J. R., Burnell-Nugent, M., Lossignol, D., Ganae-Motan, E. D., Potts, R., & Fallon, M. T. (2010) · Journal of Pain and Symptom Management · doi:10.1016/j.jpainsymman.2009.06.008 · Cited by 622
Self-citationAction of cannabidiol on the anxiety and other effects produced by ?9-THC in normal subjects
Zuardi, A. W., Shirakawa, I., Finkelfarb, E., & Karniol, I. G. (1982) · Psychopharmacology · doi:10.1007/bf00432554 · Cited by 608
Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire
Marquis, P., de la Loge, C., Dubois, D., Mcdermott, A., & Chassany, O. (2005) · Scandinavian Journal of Gastroenterology · doi:10.1080/00365520510012208 · Cited by 586
Palesh, O. G., Roscoe, J. A., Mustian, K. M., Roth, T., Savard, J., Ancoli-Israel, S., Heckler, C., Purnell, J. Q., Janelsins, M. C., & Morrow, G. R. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2009.22.5011 · Cited by 557
Portenoy, R. K. (2011) · The Lancet · doi:10.1016/s0140-6736(11)60236-5 · Cited by 491
Self-citationNovotna, A., Mares, J., Ratcliffe, S., Novakova, I., Vachova, M., Zapletalova, O., Gasperini, C., Pozzilli, C., Cefaro, L., Comi, G., et al. (2011) · European Journal of Neurology · doi:10.1111/j.1468-1331.2010.03328.x · Cited by 475
Management of opioid side effects in cancer-related and chronic noncancer pain: a systematic review
McNicol, E. D., Horowicz-Mehler, N., Fisk, R. A., Bennett, K. C., Gialeli-Goudas, M., Chew, P. W., Lau, J., & Carr, D. B. (2003) · Journal of Pain · doi:10.1016/s1526-5900(03)00556-x · Cited by 466
Nurmikko, T. J., Serpell, M. G., Hoggart, B., Toomey, P. J., Morlion, B. J., & Haines, D. (2007) · Pain · doi:10.1016/j.pain.2007.08.028 · Cited by 431
The Epidemiology of Cancer Pain
Goudas, L. C., Bloch, R. M., Gialeli-Goudas, M., Lau, J., & Carr, D. B. (2005) · Cancer Investigation · doi:10.1081/cnv-50482 · Cited by 256
Welch, S. P., & Stevens, D. L. (1992) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1016/s0022-3565(25)10720-9 · Cited by 208
Pharmacological interaction between cannabidiol and ?9-tetrahydrocannabinol
Karniol, I. G., & Carlini, E. A. (1973) · Psychopharmacology · doi:10.1007/bf00428793 · Cited by 182
Cannabinoid–opioid interactions during neuropathic pain and analgesia
Bushlin, I., Rozenfeld, R., & Devi, L. A. (2009) · Current Opinion in Pharmacology · doi:10.1016/j.coph.2009.09.009 · Cited by 163
Wade, D. T., Collin, C., Stott, C. G., & Duncombe, P. (2010) · Multiple Sclerosis Journal · doi:10.1177/1352458510367462 · Cited by 151
The Enhancement of Morphine Antinociception in Mice by Î9-Tetrahydrocannabinol
Smith, F. (1998) · Pharmacology Biochemistry and Behavior · doi:10.1016/s0091-3057(98)00012-4 · Cited by 146
NCCN Practice Guidelines for Cancer Pain.
Benedetti, C., Brock, C., Cleeland, C. S., Coyle, N., Je, D., Ferrell, B. A., Hassenbusch, S., Na, J., Mj, L., Mh, L., et al. (2000) · PubMed · Cited by 139
Cannabinoids and Multiple Sclerosis
Pertwee, R. G. (2007) · Molecular Neurobiology · doi:10.1007/s12035-007-0005-2 · Cited by 112
Evidence Report on the Treatment of Pain in Cancer Patients
Carr, D. B. (2004) · JNCI Monographs · doi:10.1093/jncimonographs/lgh012 · Cited by 98
Interaction of the cannabinoid and opioid systems in the modulation of nociception
Welch, S. P. (2009) · International Review of Psychiatry · doi:10.1080/09540260902782794 · Cited by 92
Reche, I., Fuentes, J. A., & Ruiz-Gayo, M. (1996) · European Journal of Pharmacology · doi:10.1016/s0014-2999(96)00752-2 · Cited by 87
Neuropharmacology and therapeutic potential of cannabinoids
Pertwee, R. G. (2000) · Addiction Biology · doi:10.1080/13556210071252 · Cited by 85
Onselen, C. V., Dunn, L. B., Lee, K. A., Dodd, M. J., Koetters, T., West, C. M., Paul, S. M., Aouizerat, B. E., Wara, W., Swift, P. S., et al. (2010) · European Journal of Oncology Nursing · doi:10.1016/j.ejon.2009.12.002 · Cited by 43
[Adjuvant analgesics in pain management].
Önal, S. A. (2006) · PubMed · Cited by 36
Krakowski, I., Theobald, S., Balp, L., Bonnefoi, M.-P., Chvetzoff, G., Collard, O., Collin, E., Couturier, M., Delorme, T., Duclos, R., et al. (2003) · British Journal of Cancer · doi:10.1038/sj.bjc.6601086 · Cited by 26
The principles of cancer pain management
Fallon, M., & McConnell, S. (2006) · Clinical Medicine · doi:10.7861/clinmedicine.6-2-136 · Cited by 24
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Cannabinoids for Medical Use: A Systematic Review and Meta-analysis
Whiting, P. F., Wolff, R. F., Deshpande, S., Di Nisio, M., Duffy, S., Hernandez, A. V., Keurentjes, J. C., Lang, S., Misso, K., Ryder, S., et al. (2015) · JAMA · doi:10.1001/jama.2015.6358 · Cited by 2,169
Management of cancer pain in adult patients: ESMO Clinical Practice Guidelines
Fallon, M., Giusti, R., Aielli, F., Hoskin, P., Rolke, R., Sharma, M., & Ripamonti, C. I. (2018) · Annals of Oncology · doi:10.1093/annonc/mdy152 · Cited by 954
Self-citationPractical considerations in medical cannabis administration and dosing
MacCallum, C. A., & Russo, E. B. (2018) · European Journal of Internal Medicine · doi:10.1016/j.ejim.2018.01.004 · Cited by 663
Adult Cancer Pain, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology
Swarm, R. A., Paice, J. A., Anghelescu, D. L., Are, M., Bruce, J. Y., Buga, S., Chwistek, M., Cleeland, C. S., Craig, D. S., Gafford, E. F., et al. (2019) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2019.0038 · Cited by 627
Black, N., Stockings, E., Campbell, G., Tran, L. T., Zagic, D., Hall, W. D., Farrell, M., & Degenhardt, L. (2019) · The Lancet Psychiatry · doi:10.1016/s2215-0366(19)30401-8 · Cited by 564
Metadata
- 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 (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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