First cannabis clinical trial takes off in South Africa

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In addition to demonstrating therapeutic efficacy and pain relief, the objective is to provide credible, reliable, and verifiable data to the relevant authorities to regulate the availability of medicinal cannabis.

A global crisis continues to arise as a result of opioid misuse, which is responsible for thousands of deaths every year.

Overdose deaths from drugs in the United States numbered 91,799 in 2020, with opioids accounting for 68,630 (74.8%). According to estimates by the World Health Organization focused on opioid overdose, approximately 115,000 people died of opioid overdose in 2017.

Medications such as morphine, fentanyl, and tramadol are commonly used as opioid pain relievers.

The WHO further states that it is possible to become dependent on opioids if non-medical use, prolonged use, misuse, and use without medical supervision are involved. Overdoses caused by opioids can be fatal due to their pharmacological effects.

First cannabis clinical trial in South Africa

Since the cannabis industry has become more customer-centric and customer-facing over the past few years as patients, consumers, and society have become more educated, the industry has seen significant growth.

In collaboration with the Releaf cannabis e-clinics, a member of the ImpiloVest group, participants of the latest groundbreaking study will have access to their medicinal cannabis through the study.

Patients who register for the study will not be charged for their medication as part of the sponsorship.

Shiksha Gallow, the principal investigator on the research study, a cannabis clinician, and global cannabis leader, will work alongside a team of highly skilled doctors in the medical cannabis industry, including Regina Hurley, Ahmed Jamaloodeen, Omphemetse Mathibe, and Xavagne Leigh Fransman.

The case for cannabis use

Gallow says that while the South African Health Products Regulatory Authority (Sahpra) does not yet have any official cannabis-containing medicines approved for pain relief, anecdotal evidence and preliminary studies point towards its potential to be highly effective in pain management.

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She explains: “Chronic pain is defined as pain that lingers for longer than six months and can be categorised as visceral, somatic, and neurogenic.

Given the broad spectrum, a wide range of treatments exist, from over-the-counter drugs; to opiates such as morphine, oxycodone, or codeine, which instruct the body’s natural opioid receptors to prevent the nerves responsible for pain from signalling.”

Furthermore, Gallow notes that while opiates can be highly effective in pain management, over time the body will develop a tolerance, meaning that the dose needs to be systematically increased to bring relief, which can lead to dependence.

“In addition, opiates are associated with a plethora of side effects, including sedation, respiratory depression - and even death. With the global increase in opiate addiction, which brings with it far-reaching repercussions - from ill health to broader societal issues such as crime - the research will be focused on establishing a safer alternative to treating pain.

The global ramifications

Bella Dorrington, a senior researcher at the Cannabis Research Institute of South Africa, says the study has the potential to change the medicinal landscape not only in the country but across the globe.

“CRI is pleased to participate in this study, which aims to emphasise the benefits of cannabis treatment. South Africa is poised to set a standard for medicinal cannabis in the world’s market as we have the resources, technology, and people to make it happen. The culture at our company is one of collaboration, not working in silos.”

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Willco Janse van Vuuren, head of ImpiloVest retail division and managing director of Releaf Pharmaceuticals, says creating better solutions for patients is at the core of the study.

“A health-focused, conscious community needs solutions that address its needs. Medical cannabis is gaining a great deal of attention as a powerful and proven alternative to conventional medicine.

"A primary healthcare approach is high on the priority list of people who cultivate a healthy lifestyle. With our care and your trust, together we can make a real difference in healthcare. We also believe that mental, physical and social wellbeing is a basic right.”

The study, which has received worldwide interest with many countries and international medical professionals eagerly awaiting the results, has been approved by Pharma-ethics, the Department of Health, and the South African Medical Research Council (SAMRC).

Sahpra has been notified about the sponsor and the study protocol.