Labat Africa 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 last week, adding that a pilot study has already shown that 98% of patients had obtained pain relief from the cannabis.
Biodata is a subsidiary of JSE-listed Labat Africa, an investment holding company which is the brainchild of Dr Shiksha Gallow, a cannabis clinician, and the principal investigator in the trials, which took more than 18 months to get official clearance.
BusinessTech reports that ultimately the study will involve 1,000 people who have been taking opioids for pain management for at least three months and are prepared to switch to cannabis as an alternative.
Gallow said the chemovars currently being used in the study are ‘Tallyman’ and ‘Exodus,’ 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 group said. Aquaponics is a cultivation technique offering 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;
Gallow said: “We are currently recruiting patients, and data-capturing the questionnaires and feedback for the live study. More options have been introduced as suggested by the patients in the pilot study.”
The pilot study results were very promising, showing 98% of the patients have some sort of pain relief from the cannabis, he added.
“We were able to wean these patients off their opioid treatment. In the patients under 55, it was shown they preferred to smoke the cannabis, while patients older than 55 preferred the oil. Those 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 relevant data has been collated, the results of the study will be published.”
Labat is expanding its retail footprint over the next few months by introducing CannAfrica kiosks in shopping malls that will also serve as Biodata dispensaries: it is engaging with vape stores to do the same.
See more from MedicalBrief archives:
Labat enters agreement with CSIR to produce medicinal cannabis
Labat Africa buys into the medical-cannabis training market
Biodata: First SA approval of trial investigating medical cannabis in management of chronic pain