South Africa’s first cannabis clinical trial starts – here’s what you need to know
JSE-Listed investment holding company Labat Africa says it has begun South Africa’s first ethically-approved cannabis clinical trials – the Pharma Ethics Observational Study.
The Biodata research project is to test whether cannabis can replace opioids in the management of chronic pain, the firm said in a statement on Tuesday (21 June). Biodata, a subsidiary of Labat Africa, is the brainchild of Dr Shiksha Gallow, a cannabis clinician, and the principal investigator in the trials, which took over 18 months to get official clearance.
Ultimately 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.
Researchers predict that 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”.
Dr Gallow said the chemovars currently being used in the study are ‘Tallyman’ and ‘Exodus,’ which are being sourced from Labat’s Sweetwaters Aquaponics SAHPRA-licensed facility in the Eastern Cape.
Other strains “specific for pain” are undergoing R&D at Sweetwaters, the listed group said. Aquaponics is a cultivation technique that offers health benefits in and of itself. Aquaponics is also a niche, and patients receive chemical-free super-organic medicine, the group said.
‘9 Pound Hammer’ will be the next strain introduced into the Study as it also has a high THC and CBG cannabinoid profile, and is rich in Beta Caryophyllene and Myrcene terpenes, which should assist patients with their chronic pain. Various formulations have been introduced based on the needs of patients, said Labat.
The two main formulations include the following:
- Flower: High THC: 15 – 25 mg THC/ 0.5 mg of CBD;
- Oil (1:1 ratio): Balanced formulation: 15 – 20 mg THC/15 – 20 mg CBD;
Dr Gallow said: “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 in the live study as suggested by the patients in the pilot study.
The pilot results of the study were very promising, as it showed 98% of the patients have some sort of pain relief from the cannabis, said Gallow.
“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 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.”
How it works is that the patient will apply on the Biodata website – www.biodataresearch.co.za – to be a research participant.
“We are improving this and will soon be launching a Biodata Research mobile app. 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,” said Dr Gallow.
“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 due to the severity of their medical condition, the doctor will arrange this.”
Labat said it 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 the “ideal locations for physical-sign-up- points for the study”. It added that the kiosks will also serve as Biodata dispensaries and is engaging with a number of vape stores to do the same.
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