New cannabis clinical trial launched in South Africa
12-Nov-22 05:03:45
The Cannabis Research Institute of South Africa (CRI) will sponsor the first observational clinical trial on medicinal cannabis’ effectiveness in curbing opioid addiction in South Africa.
The sponsored trial will be a year-long study that examines the effectiveness of medical cannabis as an alternative to opioids for chronic pain management. 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 in South Africa, said the CRI.
The study will be conducted in collaboration with the Releaf Cannabis E-Clinics, and registered participants will have free access to their medicinal cannabis through the trial. The trail will be headed up by cannabis clinician Dr Shiksha Gallow, who will work alongside a team of highly skilled doctors in the medical cannabis industry.
“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,” said Gallow.
She explained that chronic pain is defined as pain that lingers for longer than six months and can be categorised as visceral, somatic, and neurogenic. This has led to a wide range of treatments – including over-the-counter drugs and opiates such as morphine, oxycodone, or codeine, which instruct the body’s natural opioid receptors to prevent the nerves responsible for pain from signalling.
However, Gallow noted 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.
“Opiates are associated with many side effects, including sedation, respiratory depression – and even death. With the global increase in opiate addiction, which brings far-reaching repercussions – from ill health to broader societal issues such as crime – the research will be focussed on establishing a safer alternative to treating pain,” she said.
Opioid misuse 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%).
The World Health Organization (WHO) noted that medications such as morphine, fentanyl, and tramadol are commonly used as opioid pain relievers, and it is possible to become dependent on opioids if used recklessly.
Bella Dorrington, a Senior Researcher at the CRI, said the study has the potential to change the medicinal landscape not only in South Africa but across the globe.
“This study 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,” said Dorrington.
Willco Janse van Vuuren, the managing director of Releaf Pharmaceuticals, added that 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,” he said.
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 (DOH), and the South African Medical Research Council (SAMRC).
SAHPRA has been notified about the sponsor and the study protocol.
SOURCE: BUSINESS TECH