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An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics.
J Pain Symptom Manage. 2013 Aug; 46(2):207-18.JP

Abstract

CONTEXT

Chronic pain in patients with advanced cancer poses a serious clinical challenge. The Δ9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (U.S. Adopted Name, nabiximols; Sativex(®)) is a novel cannabinoid formulation currently undergoing investigation as an adjuvant therapy for this treatment group.

OBJECTIVES

This follow-up study investigated the long-term safety and tolerability of THC/CBD spray and THC spray in relieving pain in patients with advanced cancer.

METHODS

In total, 43 patients with cancer-related pain experiencing inadequate analgesia despite chronic opioid dosing, who had participated in a previous three-arm (THC/CBD spray, THC spray, or placebo), two-week parent randomized controlled trial, entered this open-label, multicenter, follow-up study. Patients self-titrated THC/CBD spray (n=39) or THC spray (n=4) to symptom relief or maximum dose and were regularly reviewed for safety, tolerability, and evidence of clinical benefit.

RESULTS

The efficacy end point of change from baseline in mean Brief Pain Inventory-Short Form scores for "pain severity" and "worst pain" domains showed a decrease (i.e., improvement) at each visit in the THC/CBD spray patients. Similarly, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 scores showed a decrease (i.e., improvement) from baseline in the domains of insomnia, pain, and fatigue. No new safety concerns associated with the extended use of THC/CBD spray arose from this study.

CONCLUSION

This study showed that the long-term use of THC/CBD spray was generally well tolerated, with no evidence of a loss of effect for the relief of cancer-related pain with long-term use. Furthermore, patients who kept using the study medication did not seek to increase their dose of this or other pain-relieving medication over time, suggesting that the adjuvant use of cannabinoids in cancer-related pain could provide useful benefit.

Authors+Show Affiliations

Shropshire and Mid-Wales Hospice, Shrewsbury, Shropshire, United Kingdom. jeremyjohnson@severnhospice.org.ukNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23141881

Citation

Johnson, Jeremy R., et al. "An Open-label Extension Study to Investigate the Long-term Safety and Tolerability of THC/CBD Oromucosal Spray and Oromucosal THC Spray in Patients With Terminal Cancer-related Pain Refractory to Strong Opioid Analgesics." Journal of Pain and Symptom Management, vol. 46, no. 2, 2013, pp. 207-18.
Johnson JR, Lossignol D, Burnell-Nugent M, et al. An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics. J Pain Symptom Manage. 2013;46(2):207-18.
Johnson, J. R., Lossignol, D., Burnell-Nugent, M., & Fallon, M. T. (2013). An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics. Journal of Pain and Symptom Management, 46(2), 207-18. https://doi.org/10.1016/j.jpainsymman.2012.07.014
Johnson JR, et al. An Open-label Extension Study to Investigate the Long-term Safety and Tolerability of THC/CBD Oromucosal Spray and Oromucosal THC Spray in Patients With Terminal Cancer-related Pain Refractory to Strong Opioid Analgesics. J Pain Symptom Manage. 2013;46(2):207-18. PubMed PMID: 23141881.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics. AU - Johnson,Jeremy R, AU - Lossignol,Dominique, AU - Burnell-Nugent,Mary, AU - Fallon,Marie T, Y1 - 2012/11/08/ PY - 2012/04/19/received PY - 2012/07/26/revised PY - 2012/07/28/accepted PY - 2012/11/13/entrez PY - 2012/11/13/pubmed PY - 2014/2/25/medline KW - Cancer KW - THC/CBD oromucosal spray KW - cannabinoid KW - delta-9-tetrahydrocannabinol KW - pain SP - 207 EP - 18 JF - Journal of pain and symptom management JO - J Pain Symptom Manage VL - 46 IS - 2 N2 - CONTEXT: Chronic pain in patients with advanced cancer poses a serious clinical challenge. The Δ9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (U.S. Adopted Name, nabiximols; Sativex(®)) is a novel cannabinoid formulation currently undergoing investigation as an adjuvant therapy for this treatment group. OBJECTIVES: This follow-up study investigated the long-term safety and tolerability of THC/CBD spray and THC spray in relieving pain in patients with advanced cancer. METHODS: In total, 43 patients with cancer-related pain experiencing inadequate analgesia despite chronic opioid dosing, who had participated in a previous three-arm (THC/CBD spray, THC spray, or placebo), two-week parent randomized controlled trial, entered this open-label, multicenter, follow-up study. Patients self-titrated THC/CBD spray (n=39) or THC spray (n=4) to symptom relief or maximum dose and were regularly reviewed for safety, tolerability, and evidence of clinical benefit. RESULTS: The efficacy end point of change from baseline in mean Brief Pain Inventory-Short Form scores for "pain severity" and "worst pain" domains showed a decrease (i.e., improvement) at each visit in the THC/CBD spray patients. Similarly, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 scores showed a decrease (i.e., improvement) from baseline in the domains of insomnia, pain, and fatigue. No new safety concerns associated with the extended use of THC/CBD spray arose from this study. CONCLUSION: This study showed that the long-term use of THC/CBD spray was generally well tolerated, with no evidence of a loss of effect for the relief of cancer-related pain with long-term use. Furthermore, patients who kept using the study medication did not seek to increase their dose of this or other pain-relieving medication over time, suggesting that the adjuvant use of cannabinoids in cancer-related pain could provide useful benefit. SN - 1873-6513 UR - https://www.unboundmedicine.com/medline/citation/23141881/An_open_label_extension_study_to_investigate_the_long_term_safety_and_tolerability_of_THC/CBD_oromucosal_spray_and_oromucosal_THC_spray_in_patients_with_terminal_cancer_related_pain_refractory_to_strong_opioid_analgesics_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0885-3924(12)00439-3 DB - PRIME DP - Unbound Medicine ER -