South Africa’s first cannabis trial has launched after initial results “show promise” for the treatment as a replacement for opioids.
The Pharma Ethics Observational Study is led by Biodata, a subsidiary of Labat Africa, and will test whether cannabis can replace opioids in the management of chronic pain.
The study will involve 1,000 participants who have been taking opioids for pain management for at least three months and are prepared to switch to cannabis as an alternative.
Biodata is the brainchild of Dr Shiksha Gallow, a cannabis clinician and the principal investigator in the trial which took over 18 months to get official clearance.
Dr Gallow said the trial is set to be ground-breaking as South Africa’s first real-world study of medical cannabis. Researchers predict that it will provide much-needed insight into the link between cannabis genetics and patient outcomes.
Dr Gallow told Cannabiz Africa: “We are currently recruiting patients, and data-capturing all the questionnaires and feedback from the patients for the live Study. It has been fairly slow. However, more options have been introduced, as suggested by the patients in the pilot study.
“The pilot results of the study were very promising, as it showed 98 per cent of the patients have some sort of pain relief from the cannabis.
“We were able to wean these patients off their opioid treatment. In the pilot group of patients below the age of 55, it was shown this group preferred to smoke cannabis and patients older than 55 years preferred oil. The patients who smoked the cannabis had relief almost immediately, while the oil took some time to alleviate their pain.”
“Once we reach the sample size required and all of the relevant data has been collated, the results of the study will be published. We have currently renewed this study for another year, due to the initial slow uptake of research participants.”
Patients can apply to be research participants through the Biodata website.
Labat is expanding its footprint over the next few months with the introduction of CannAfrica kiosks in major shopping malls.
The company believes these will be the “ideal locations for physical sign-up points for the study”.
Labat said the kiosks will also serve as Biodata dispensaries and is engaging with a number of vape stores to do the same, although these would have to be subject to South African Health Products Regulatory Authority’s pharma-ethics requirements.
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