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Let's be blunt: 'Very promising' early results in cannabis trial for opioid users, says Labat
An "ethically approved" clinical trial to test whether cannabis can replace opioids in the management of chronic pain has kicked off in SA, with "very promising" results in the pilot phase.
This is according to a statement from investment holding company Labat Africa, which has a focus on medical cannabis. Labat, which is listed on both the JSE and Frankfurt stock exchanges, exports over a quarter of its SA health Products Regulatory Authority-approved medical cannabis crop from Kenton-on-Sea to Australia and Europe.
Its recent acquisitions include Miami-owned CBD brand Echo Life.
In a notice to shareholders on Tuesday afternoon, Labat said Biodata's study on pain management using cannabis – the Pharma Ethics Observational Study – would involve 1 000 participants who had been taking opioids for pain management for at least three months who were prepared to switch to cannabis as an alternative.
The opioid family of painkillers includes drugs such as codeine, pethidine and morphine.
Biodata is a subsidiary of Labat Africa. Dr Shiksha Gallow, described by Labat as a "cannabis clinician", is the principal investigator in the trials, which took over 18 months to get clearance.
Gallow described the trials as groundbreaking and said it would provide insight into the link between cannabis genetics and patient outcomes, as well as helping doctors with an alternative for their patients to treat chronic pain.
The study comes amid rising concerns over opioid dependency.
"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. 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," Gallow said.
"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 initially slow uptake of research participants."
It's ganja be great
Gallow's team is currently recruiting patients, and data capturing all the questionnaires and feedback from the patients for the live study. "It has been fairly slow," Gallow said. "However, more options have been introduced in the live study as suggested by the patients in the pilot study."
The chemovars 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, with aquaponics as a cultivation technique.
"Aquaponics is also a niche, and patients receive chemical-free super-organic medicine," said Labat. "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."
Patients apply via the Biodata website to be a research participant, with an app in the pipeline.
Once the patient is approved by the doctor as a research participant, an informed consent form and baseline questionnaires are completed by the participant. After this, the prescribing doctor determines the correct dosages.
All doctor's visits are online, though in-person visits can be done as needed.
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. Labat says the kiosks will also serve as Biodata dispensaries and says it is engaging with a number of vape stores to do the same, although these would have to be subject to SAHPRAs pharma-ethics requirements.
© 420 Intel
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