The first clinical trial of its kind in South Africa, probing cannabis’ effectiveness as an alternative to opioids for chronic pain management, aims to enrol 300 participants.
A condition is that they must suffer from chronic pain, or pain that lingers for longer than six months. The results are expected late in 2023, reports Business Insider.
The year-long study is being sponsored by the Cannabis Research Institute of South Africa (CRI), which hopes it will provide credible, reliable and verifiable data on medicinal cannabis. The trial comes amid South Africa’s perception shift regarding the plant, which has grown since the 2018 Constitutional Court ruling decriminalising private, personal use of cannabis.
Since then, the private sector has piled into South Africa’s “green rush” while government’s own Cannabis Master Plan looks to industrialise the plant and unlock more than 25 000 direct jobs. But legislative progress, in the form of the Cannabis for Private Purposes Bill currently before Parliament, has been slow, leaving more unanswered questions around the recreational and medicinal uses of the plant.
Cannabis in medication form has been legalised in most American states, Canada, the United Kingdom, Australia and much of Europe and South America. While the plant’s use is legal in South Africa, the South African Health Products Regulatory Authority (Sahpra) does not yet have any official cannabis-containing medicines approved for pain relief.
Opioids, like morphine, fentanyl and tramadol, remain the most common treatment for pain. They’re also highly addictive and can cause breathing difficulty when overdosed, leading to death.
Of the estimated 500 000 global deaths attributable to drug use, more than 70% are related to opioids, says the World Health Organisation (WHO). South Africa has seen a sharp increase in treatment admission trends for opioids over the past decade, according to the South African Medical Research Council (SAMRC).
“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 range of treatments exists, from over-the-counter drugs; to opiates like morphine, oxycodone, or codeine, which instruct the body’s natural opioid receptors to prevent the nerves responsible for pain from signalling,” said Dr Shiksha Gallow, the principal investigator on the research study.
“However, opiates are linked to a plethora of side effects, including sedation, respiratory depression, and even death. With the global increase in opiate addiction, this research will be focused on establishing a safer alternative to treating pain.”
The first South African trial, in collaboration with Releaf Cannabis E-Clinics, a member of the ImpiloVest group, gives participants access to their medicinal cannabis throughout the study.
The 12-month study, which is still accepting participants, will ensure “they stay on the medication until weaning off opioids becomes possible”. Medicines will be provided free to patients, who will need to complete questionnaires each month before getting their next prescription.
Three consultations will be provided to patients during the year, and any urgent consultations will be made available if necessary.
All patients participating in the study need to prove they suffer from chronic pain. These patients typically have illnesses or diseases such as rheumatoid arthritis, multiple sclerosis, fibromuscular, osteoarthritis, or even cancer-related conditions.
The trial has been approved by South Africa’s Department of Health and the SAMRC.
See more from MedicalBrief archives:
Small players ‘not considered’ in South African cannabis Bill – Free Market Foundation
DoH: Cannabis Bill ‘a slippery slope’ because of potential harm to adolescents
Cannabis Bill flawed by privacy and equality concerns