JSE-listed cannabis products company Labat says it has started South Africa’s first ethically-approved cannabis clinical trial – the Pharma Ethics Observational Study. The Biodata research project 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 a subsidiary of Labat Africa and the brainchild of Dr Shiksha Gallow, who is the principal investigator in the trial, which required more than 18 months to get official clearance.
The trial has been called South Africa’s first real-world study of medical cannabis and researchers expect it will provide much-needed insight into the link between cannabis genetics and patient outcomes.
This study will also assist doctors across the globe with a safer alternative for their patients to treat chronic pain, she says.
The chemovars, or plant species based on chemicals, currently being used in the study are Tallyman and Exodus, which are being sourced from Labat’s Sweetwaters Aquaponics South African Health Products Regulatory Authority- (Sahpra-) licensed facility in the Eastern Cape.
Other strains specific for pain are undergoing research and development also at Sweetwaters.
Further, aquaponics as a cultivation technique offered health benefits in and of itself, the company says.
“Aquaponics is also a niche, and patients receive chemical-free, organic medicine. Nine Pound Hammer will be the next strain introduced into the study, as it also has a high tetrahydrocannabinol and cannabigerol cannabinoid profile, and is rich in beta caryophyllene and myrcene terpenes, which should assist patients with their chronic pain,” Gallow says.
“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 going; however, more options have been introduced in the live study, as suggested by the patients in the pilot study,” she says.
The pilot results of the study were very promising, as it showed 98% of the patients had some 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 the cannabis, and patients older than 55 years preferred the oil. The patients who smoked the cannabis had relief almost immediately, while the oil took some time to alleviate 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, owing to the initially slow uptake of research participants,” Gallow says.
She says patients apply on the Biodata website to be research participants.
“We are improving this and will soon be launching a Biodata Research mobile application. Once the patient is approved by the doctor as a research participant, an informed consent form and baseline questionnaires would have to be completed by the participant.
“Then, once the questionnaires are completed, the prescribing doctor will assist the patient with the correct dosages that need to be taken. The doctors’ visits are all online, and there will be a total of four online consults with the doctors. Should a doctor need to see the patient in person owing to severity of their medical condition, the doctor will arrange this,” says Gallow.
Meanwhile, Labat is expanding its retail footprint over the next few months with the introduction of CannAfrica kiosks in major shopping malls and believes these will be ideal locations for physical sign-up points for the study.
The kiosks will also serve as Biodata dispensaries and it is engaging with a number of vape stores to do the same, although these would have to be subject to the Sahpra’s pharma-ethics requirements, the company says.