Dr Hance Clarke tells MCN about the Medical Cannabis Real-World Evidence clinical trial.
Dr Hance Clarke, MSc, MD, PhD, FRCPC is the Medical Director of the Pain Research Unit at Toronto General Hospital. He is leading the pioneering Medical Cannabis Real-World Evidence clinical trial, which aims to gauge the effects of various forms of cannabis and cannabinoids on patients, using validated and standardised products to eliminate the common issue of batch-to-batch variance.
Participants in the trial will be able to select their preferred method of cannabis delivery using a dedicated portal and their experiences will be monitored over a six-month period. Dr Clarke tells us more.
What first drew your attention to the potential offered by medical cannabis?
As an anaesthesiologist and a pain physician I have had many patients over the years speak to me about the benefits of cannabis for pain, sleep, anxiety etc; and I could only listen and nod my head. As of 2014 with the new guidelines created in Canada, cannabis became a substance more accessible to patients and for healthcare providers to authorise and scientifically study. For decades patients have claimed that cannabis was useful for conditions such as HIV neuropathy (Toronto had one of the largest cannabis dispensaries for decades that served the HIV community). Furthermore, my pain patients would tell me that inhalational cannabis at night was what took the edge off their neuropathic pain symptoms and afforded them a great night’s sleep.
Over the past seven years the cannabis sector has exploded in North America and a global industry has developed. This is a moment where we start to identify products with therapeutic benefit. For the most part, we have no idea what the major constituents are in the products that patients are currently consuming and there is a huge variability from one purchase to the next. As a medically complex patient, you want to ensure that the product you consume today is the product that you will acquire three to four months from now and this certainly has not been the case. I would like to help create a sense of reliability and safety for my patients, given they must spend their hard-earned dollars on these products.
What are the key goals of the Medical Cannabis Real-World Evidence study?
To describe the effectiveness of medical cannabis on pain, sleep, anxiety and depression in a cohort of patients authorised to use validated medical cannabis products, using pre-defined, validated self-assessment scales. The study will gauge patient-reported improvement of symptoms at baseline, six, 12 and 24 weeks for pain, sleep, depression, anxiety, and depression; as well as overall quality of life.
The secondary endpoints examined in the study will include:
- Demographic and clinical characteristics of patients authorised for medical cannabis in Canada (for example age, sex, comorbidities, concomitant medications, etc)
- Patient satisfaction with the online medical cannabis prescription platform Medical Cannabis By Shoppers, to be determined using a final user survey at the conclusion of the study
- Changes in prescription medications of interest such as opioids, antidepressants, anxiolytics and high dosage anti-inflammatories, from baseline to six months
Participants will be enrolled in the study at the time of their initial medical cannabis consultation, which can be conducted in person or through scheduled telemedicine appointments. All patient reported outcomes and medical history questionnaires are completed online; and study participants will be compensated for their time in completing the validated questionnaires.
By examining the different effects of differing strains and strengths of cannabis products, could the data gathered over the course of the study be used to develop personalised treatments in the future?
It absolutely could. This initial study will serve to inform future studies that will examine a specific validated and verified medical cannabis strain, dosing and therapeutic outcomes for each patient.
While there is growing evidence that medical cannabis may be an effective therapeutic option for patients suffering from chronic medical conditions, clinical research on medical cannabis has focused primarily on short-term outcomes, with limited attention to long-term benefits of specific strains and dosing regimens. In addition, patients using medical cannabis are generally unable to maintain a defined treatment regimen (whether defined by strain name, biochemical composition, or mode of ingestion) over a long period of time, because there is allowance for recreational and licensed medical producers to change their strains and product lineup without notice – in effect, no quality standards for medical cannabis have been fully defined.
Subtle changes in strain composition may have significant clinical effects; and with so many strains to choose from, these small changes complicate patients’ ability to optimise their overall health outcomes, as well as researchers’ ability to study long-term effectiveness and safety of medical cannabis in general, and specific strains in particular. The current real-world study addresses these complexities by providing patients defined medical cannabis strains and products, allowing them to maintain their treatment if desired or alter its composition in order to identify dosing regimens that work for them.
Cannabis products can now be ‘genetically fingerprinted’ and clearly identified. Key information, including DNA genetics and cannabinoid and terpene compositions, can be collated into a Master Strain Certificate. This certification can then be embedded into a cannabis barcode which carries comprehensive information about the strain.
Have you experienced any challenges in getting the study set up or approved?
We have been very successful at getting the study approved through ethics co-ordinators. We have also been fortunate to have great partners at the table, including the pharmacy chain Shoppers Drug Mart, who have developed a unique e-prescription portal for healthcare practitioners; as well as a large number of licensed producers who have committed to validate their medical cannabis products into the study formulary.
Many physicians are still sceptical or unsure about prescribing cannabis as a medical treatment. What are the main factors affecting this scepticism?
The average physician has not had exposure to the body of literature that speaks to the potential of medical cannabis in clinical care. As such many physicians are uncomfortable authorising medical cannabis use, often because they lack the clinical knowledge to provide recommendations to patients. Continuing medical education, modules such as the one being created by the Canadian Consortium for the Investigation of Cannabinoids – which will be launched in the autumn of 2020 – would be a great source for physician education. It will include key basic science knowledge as well as clinical evidence via a balanced lens as it relates to benefits and risks of cannabis use.
Could better education or a broader evidence base improve the situation?
A broader evidence base is a must, however it must be compiled with scientific rigour; and we need to start with reliable products that are validated, reliable and replicable. There must be continued efforts to ensure that patients, healthcare providers, policymakers and regulators understand the cannabis industry’s strengths and pitfalls. Medical, nursing and pharmacy schools should discuss the role of the endogenous endocannabinoid system within the context of the decades of basic science research to date.
Dr Hance Clarke, MSc, MD, PhD, FRCPC
Director, Pain Services
Director, Good Hope Ehlers Danlos Clinic
Medical Director, Pain Research Unit
Department of Anaesthesia and Pain Management
Toronto General Hospital