- A study in South Africa is looking to examine cannabis’ effectiveness as an alternative to opioids for chronic pain management.
- Touted as the first clinical trial of its kind in South Africa, it’s aiming to enrol 300 participants.
- These participants will receive a year’s worth of cannabis medication for free.
- But must prove that they suffer from chronic pain, defined as pain that lingers for longer than six months.
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South Africa’s first cannabis clinical trial examining the plant’s effectiveness as an alternative to opioids for chronic pain management looks to enrol 300 participants, with the results expected in late 2023.
The Cannabis Research Institute of South Africa (CRI) is sponsoring a year-long study that it hopes will provide credible, reliable, and verifiable data on medicinal cannabis. The clinical 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.
The use of cannabis as a medicine 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, due to their pharmacological effects, 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, according to the World Health Organisation (WHO). South Africa has seen a sharp increase in treatment admission trends for opioids over the past decade, according to a study authored by members of 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 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,” explained Dr. Shiksha Gallow, the principal investigator on the research study.
“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 focussed on establishing a safer alternative to treating pain.”
There’s been an increase in trials focused on replacing opioids with cannabis for the treatment of chronic pain, with the United States’ Centres for Disease Control and Prevention (CDC) noting that “a few studies have found that marijuana can be helpful in treating neuropathic pain, a specific type of chronic pain caused by damaged nerves.” The CDC adds that “more research is needed to know whether marijuana works better than other options to manage 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 year-long study, which is still accepting participants, will ensure “they stay on the medication until weaning off opioids becomes possible.” Medicines will be provided free of charge 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 that 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.
South Africa’s department of health and SAMRC have approved the clinical trial, according to Relief Pharmaceuticals, with SAHPRA having “been notified about the sponsor and the study protocol.”
Professor Charles Parry, director of the SAMRC’s alcohol, tobacco, and other drug research unit, told Business Insider SA that the department of health was solely responsible for approving clinical trials.
Parry provided a trial approval letter, addressed to Gallow, from the South African National Clinical Trial Registry (SANCTR). The SANCTR is supported administratively by the SAMRC on behalf of the department of health.