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, operationalising clinical trials with a medicinal cannabis product requires additional consideration of legal, regulatory, ethical, feasibility, pharmacological and product requirements.
Objective: This manuscript aims to explore these considerations when operationalising medicinal cannabis clinical trials in people receiving palliative care.
Methods: Our Phase I/IIb trial examined pharmacokinetic, toxicity and secondary (efficacy) outcomes of a vaporised 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 synthesised to reveal key design considerations for operationalising 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) Optimising trial site operationalisation; and 6) Pharmacy dispensing, storage and security of product. Learnings and recommendations for future trials are also discussed.
Conclusions: This study explores the 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 operationalisation of future medicinal cannabis trials in cancer and other chronic conditions.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.jpainsymman.2025.02.009 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
No Abstract Available.
View Article and Find Full Text PDFConsumer Contribution in Designing Medicinal Cannabis Clinical Trials in Palliative Medicine.
J Palliat Med
March 2025
South West Sydney Clinical Campuses, Faculty of Medicine and Health, University of New South Wales (UNSW) Sydney, Kensington, New South Wales, Australia.
Medicinal cannabis clinical trials in palliative medicine present unique and complex challenges encompassing ethical, legal, and feasibility obligations, making consumer input essential. However, little is known about the consumer contribution in the medicinal cannabis research space. We present a case report on consumer contribution in the design and conduct of a Phase I/IIb medicinal cannabis clinical trial for anorexia in people with advanced cancer.
View Article and Find Full Text PDFIdentifying EEG markers related to acute cannabis consumption: A systematic review.
Neurosci Biobehav Rev
March 2025
MAIC/UniSC Road Safety Research Collaboration, University of the Sunshine Coast, 90 Sippy Downs Dr, Sippy Downs, Queensland, 4556, Australia.
Background/rationale: Electroencephalography (EEG) has potential to provide a sensitive measure of the acute neurophysiological response to cannabis administration. As delta-9-tetrahydrocannabinol (THC; the psychoactive constituent of cannabis) can induce transient neurocognitive impairments that differ as a function of tolerance and dose, understanding the neural profile related to intoxication would be of great benefit in the wake of increasing recreational and medicinal use. Accordingly, the present systematic review examined the current research literature related to acute cannabis administration and EEG measures.
View Article and Find Full Text PDFMedicinal Chemistry and Detoxification of Poisonous Plants in Traditional Medicine: A Comprehensive Review.
Toxicon
March 2025
Department of Natural Products, National Institute of Pharmaceutical Education and Research, S.A.S. Nagar, Mohali 160062, Punjab, India.
Introduction: Poisonous and toxic plants are used in different traditional systems of medicine for medicinal preparations after certain processing (detoxification) method. However, the correlation between plant toxicity and their chemical constituents remains unexplored for many of these plants. A thorough study on bioactive constituents from poisonous plants could also benefit their proper utilization and improve their usage systematically.
View Article and Find Full Text PDFThe prevalence and characterisation of energy drink consumption in North America: A systematic review.
Public Health
March 2025
Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain; Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain.
Objectives: Energy drinks (ED), which contain high levels of caffeine, are widely popular and their consumption is increasing, especially among young people who may have limited understanding of the associated risks. The aim of this study was to identify the prevalence of ED consumption in North America (Canada, Mexico and the US) and to characterise ED consumers.
Study Design: Systematic review.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!