Design Considerations for Medicinal Cannabis Clinical Trials in People Receiving Palliative Care

Valentina Razmovski-Naumovski; Jennifer H. Martin; Richard Chye; Jane L. Phillips; Nicholas Lintzeris; Nadia Solowij; Jessica Lee; Melanie Lovell; Bev Noble; Peter Galettis; Linda Brown; Belinda Fazekas; Katherine Clark; Tim Luckett; Nikki McCaffrey; David C. Currow; Meera R. Agar

doi:10.1016/j.jpainsymman.2025.02.009

Design Considerations for Medicinal Cannabis Clinical Trials in People Receiving Palliative Care

Valentina Razmovski-Naumovski, Jennifer H. Martin, Richard Chye, Jane L. Phillips, Nicholas Lintzeris, Nadia Solowij, Jessica Lee, Melanie Lovell, Bev Noble, Peter Galettis, Linda Brown, Belinda Fazekas, Katherine Clark, Tim Luckett, Nikki McCaffrey, David C. Currow, Meera R. Agar

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

Context: Evaluating medicinal cannabis in clinical trials is important for informing its efficacy and safety in clinical care. Alongside the inherent practical challenges of conducting clinical trials in people receiving palliative care, operationalizing clinical trials with a medicinal cannabis product requires additional consideration of legal, regulatory, ethical, feasibility, pharmacological and product requirements. Objectives: This manuscript aims to explore these considerations when operationalizing medicinal cannabis clinical trials in people receiving palliative care. Methods: Our Phase I/IIb trial examined pharmacokinetic, toxicity and secondary (efficacy) outcomes of a vaporized medicinal cannabis product for anorexia in people with advanced cancer (ACTRN12616000516482). Using action research methodology, notes from trial investigator meetings served as an audit trail for the planning and execution of the trial. These data were integrated and synthesized to reveal key design considerations for operationalizing medicinal cannabis trials evaluating symptom control in people receiving palliative care. Results: Six key considerations emerged including: 1) Operating within medicinal cannabis legislation; 2) Biological plausibility of cannabinoid type(s) and impact on target symptoms; 3) Standardising cannabinoid content, mode of administration, dosage and packaging; 4) Ethical and safety considerations; 5) Optimizing trial site operationalization; and 6) Pharmacy dispensing, storage and security of product. Learnings and recommendations for future trials are also discussed. Conclusion: This study explores the learnings and challenges involved in designing and conducting medicinal cannabis trials for symptom management in people receiving palliative care. These insights gained from our experience can inform the optimal design and operationalization of future medicinal cannabis trials in cancer and other chronic conditions.

Original language	English
Pages (from-to)	e395-e408
Journal	Journal of Pain and Symptom Management
Volume	69
Issue number	5
DOIs	https://doi.org/10.1016/j.jpainsymman.2025.02.009
Publication status	Published - May 2025
Externally published	Yes

Bibliographical note

Publisher Copyright:
© 2025

Keywords

Anorexia
cancer
clinical trial
medicinal cannabis
palliative care
trial design

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.jpainsymman.2025.02.009

Cite this

Razmovski-Naumovski, V., Martin, J. H., Chye, R., Phillips, J. L., Lintzeris, N., Solowij, N., Lee, J., Lovell, M., Noble, B., Galettis, P., Brown, L., Fazekas, B., Clark, K., Luckett, T., McCaffrey, N., Currow, D. C., & Agar, M. R. (2025). Design Considerations for Medicinal Cannabis Clinical Trials in People Receiving Palliative Care. Journal of Pain and Symptom Management, 69(5), e395-e408. https://doi.org/10.1016/j.jpainsymman.2025.02.009

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title = "Design Considerations for Medicinal Cannabis Clinical Trials in People Receiving Palliative Care",

abstract = "Context: Evaluating medicinal cannabis in clinical trials is important for informing its efficacy and safety in clinical care. Alongside the inherent practical challenges of conducting clinical trials in people receiving palliative care, operationalizing clinical trials with a medicinal cannabis product requires additional consideration of legal, regulatory, ethical, feasibility, pharmacological and product requirements. Objectives: This manuscript aims to explore these considerations when operationalizing medicinal cannabis clinical trials in people receiving palliative care. Methods: Our Phase I/IIb trial examined pharmacokinetic, toxicity and secondary (efficacy) outcomes of a vaporized medicinal cannabis product for anorexia in people with advanced cancer (ACTRN12616000516482). Using action research methodology, notes from trial investigator meetings served as an audit trail for the planning and execution of the trial. These data were integrated and synthesized to reveal key design considerations for operationalizing medicinal cannabis trials evaluating symptom control in people receiving palliative care. Results: Six key considerations emerged including: 1) Operating within medicinal cannabis legislation; 2) Biological plausibility of cannabinoid type(s) and impact on target symptoms; 3) Standardising cannabinoid content, mode of administration, dosage and packaging; 4) Ethical and safety considerations; 5) Optimizing trial site operationalization; and 6) Pharmacy dispensing, storage and security of product. Learnings and recommendations for future trials are also discussed. Conclusion: This study explores the learnings and challenges involved in designing and conducting medicinal cannabis trials for symptom management in people receiving palliative care. These insights gained from our experience can inform the optimal design and operationalization of future medicinal cannabis trials in cancer and other chronic conditions.",

keywords = "Anorexia, cancer, clinical trial, medicinal cannabis, palliative care, trial design",

author = "Valentina Razmovski-Naumovski and Martin, {Jennifer H.} and Richard Chye and Phillips, {Jane L.} and Nicholas Lintzeris and Nadia Solowij and Jessica Lee and Melanie Lovell and Bev Noble and Peter Galettis and Linda Brown and Belinda Fazekas and Katherine Clark and Tim Luckett and Nikki McCaffrey and Currow, {David C.} and Agar, {Meera R.}",

note = "Publisher Copyright: {\textcopyright} 2025",

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month = may,

doi = "10.1016/j.jpainsymman.2025.02.009",

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Razmovski-Naumovski, V, Martin, JH, Chye, R, Phillips, JL, Lintzeris, N, Solowij, N, Lee, J, Lovell, M, Noble, B, Galettis, P, Brown, L, Fazekas, B, Clark, K, Luckett, T, McCaffrey, N, Currow, DC & Agar, MR 2025, 'Design Considerations for Medicinal Cannabis Clinical Trials in People Receiving Palliative Care', Journal of Pain and Symptom Management, vol. 69, no. 5, pp. e395-e408. https://doi.org/10.1016/j.jpainsymman.2025.02.009

TY - JOUR

T1 - Design Considerations for Medicinal Cannabis Clinical Trials in People Receiving Palliative Care

AU - Razmovski-Naumovski, Valentina

AU - Martin, Jennifer H.

AU - Chye, Richard

AU - Phillips, Jane L.

AU - Lintzeris, Nicholas

AU - Solowij, Nadia

AU - Lee, Jessica

AU - Lovell, Melanie

AU - Noble, Bev

AU - Galettis, Peter

AU - Brown, Linda

AU - Fazekas, Belinda

AU - Clark, Katherine

AU - Luckett, Tim

AU - McCaffrey, Nikki

AU - Currow, David C.

AU - Agar, Meera R.

PY - 2025/5

Y1 - 2025/5

N2 - Context: Evaluating medicinal cannabis in clinical trials is important for informing its efficacy and safety in clinical care. Alongside the inherent practical challenges of conducting clinical trials in people receiving palliative care, operationalizing clinical trials with a medicinal cannabis product requires additional consideration of legal, regulatory, ethical, feasibility, pharmacological and product requirements. Objectives: This manuscript aims to explore these considerations when operationalizing medicinal cannabis clinical trials in people receiving palliative care. Methods: Our Phase I/IIb trial examined pharmacokinetic, toxicity and secondary (efficacy) outcomes of a vaporized medicinal cannabis product for anorexia in people with advanced cancer (ACTRN12616000516482). Using action research methodology, notes from trial investigator meetings served as an audit trail for the planning and execution of the trial. These data were integrated and synthesized to reveal key design considerations for operationalizing medicinal cannabis trials evaluating symptom control in people receiving palliative care. Results: Six key considerations emerged including: 1) Operating within medicinal cannabis legislation; 2) Biological plausibility of cannabinoid type(s) and impact on target symptoms; 3) Standardising cannabinoid content, mode of administration, dosage and packaging; 4) Ethical and safety considerations; 5) Optimizing trial site operationalization; and 6) Pharmacy dispensing, storage and security of product. Learnings and recommendations for future trials are also discussed. Conclusion: This study explores the learnings and challenges involved in designing and conducting medicinal cannabis trials for symptom management in people receiving palliative care. These insights gained from our experience can inform the optimal design and operationalization of future medicinal cannabis trials in cancer and other chronic conditions.

AB - Context: Evaluating medicinal cannabis in clinical trials is important for informing its efficacy and safety in clinical care. Alongside the inherent practical challenges of conducting clinical trials in people receiving palliative care, operationalizing clinical trials with a medicinal cannabis product requires additional consideration of legal, regulatory, ethical, feasibility, pharmacological and product requirements. Objectives: This manuscript aims to explore these considerations when operationalizing medicinal cannabis clinical trials in people receiving palliative care. Methods: Our Phase I/IIb trial examined pharmacokinetic, toxicity and secondary (efficacy) outcomes of a vaporized medicinal cannabis product for anorexia in people with advanced cancer (ACTRN12616000516482). Using action research methodology, notes from trial investigator meetings served as an audit trail for the planning and execution of the trial. These data were integrated and synthesized to reveal key design considerations for operationalizing medicinal cannabis trials evaluating symptom control in people receiving palliative care. Results: Six key considerations emerged including: 1) Operating within medicinal cannabis legislation; 2) Biological plausibility of cannabinoid type(s) and impact on target symptoms; 3) Standardising cannabinoid content, mode of administration, dosage and packaging; 4) Ethical and safety considerations; 5) Optimizing trial site operationalization; and 6) Pharmacy dispensing, storage and security of product. Learnings and recommendations for future trials are also discussed. Conclusion: This study explores the learnings and challenges involved in designing and conducting medicinal cannabis trials for symptom management in people receiving palliative care. These insights gained from our experience can inform the optimal design and operationalization of future medicinal cannabis trials in cancer and other chronic conditions.

KW - Anorexia

KW - cancer

KW - clinical trial

KW - medicinal cannabis

KW - palliative care

KW - trial design

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U2 - 10.1016/j.jpainsymman.2025.02.009

DO - 10.1016/j.jpainsymman.2025.02.009

M3 - Article

C2 - 39988015

AN - SCOPUS:105000022177

SN - 0885-3924

VL - 69

SP - e395-e408

JO - Journal of Pain and Symptom Management

JF - Journal of Pain and Symptom Management

IS - 5

ER -

Design Considerations for Medicinal Cannabis Clinical Trials in People Receiving Palliative Care

Abstract

Bibliographical note

Keywords

UN SDGs

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