Biodata has go-ahead for clinical trials after 18 months of prep work
South African cannabis trials get underway next year in a major study to see to what extent opioids can be replaced by medical cannabis in managing pain. The trials will be done by Biodata, who’s CEO, Dr Shiksha Gallow, is the principal investigator. Dr Regina Hurley is co-principal investigator.
The trials are being sponsored by Biodata’s parent company, Labat Africa, which said that Biodata received approval for the trials from the Pharma-Ethics Committee on 9 June 2021, the first cannabis study to receive ethics approval in South Africa
“This is a large-scale study using Medical Cannabis Real World Evidence (MC-RWE), as 1 000 participants will be recruited using three different sites. Patients pain management while on medical cannabis will be observed and documented, side effects will also be noted as well as drug interactions. The study includes the use of both the cannabis flower and cannabis oil” the company said in a SENS announcement on 9 June 2021.
“The study investigates the replacement of opioids with medical cannabis, and would help
practitioners understand the effects of cannabinoids for pain management and stress related disorders. There are innumerable benefits that will result from this research and practitioners and researchers alike, are anxiously waiting for this study to go
Dr Gallow told a medicinal cannabis webinar on 3 December 2021 that it had taken 18 months to get approval for the trials which will focus on opiod patients who’d been suffering from chronic pain for at least three months. The trials begin next year and will involve 1 000 participants.
Pilot study findings showed cannabis helped alleviate chronic pain
“The basic question is does opioid use increase or decrease following the taking of medicinal cannabis” said Dr Galllow.
“We know that cannabis is not so effective for acute pain, but we do know it appears to be very good for chronic pain, that’s pain that outlasts the precipitating tissue injury”.
She said a pilot study of five patients all suffering from anxiety and chronic pain had been very positive with all participants experiencing pain relief and were weaned off opioids in three months.
“All of the patients started off with 100% chronic pain, and in that three month period it was below 40% for all of them.
“The next step will be to have randomized double-blinded clinical trials”
Trial patients will have four scheduled visits to a medical doctor and there will be two basic formulations on offer:
- Flower: High THC: 15 – 20 mg THC/ 0,5 mg of CBD
- Oil: Balanced formulation: 15 – 20 mg THC/15 – 20 mg CBD
The cannabis strains will be Tallyman and Exodus, with the latter having a high limonene terpine profile.
Labat said the research conducted by Dr Gallow on cannabinoids, Ayurvedic medicine as well as homeopathic medicines has been a significant enhancement to Labat Africa’s nutraceutical and pharmaceutical offerings.
“With the growing international trend of opiate addiction and its impact on overdoses, ill-health and crime, with countries worldwide searching desperately for safer alternatives to treat severe and mild pain. Now that the trials have been approved, Dr Gallow and her team of doctors will begin the recruitment of patients. Dr Gallows’ team includes likeminded practitioners, who understand the benefits of cannabis for medicinal purposes. Her team includes: Dr Regina Hurley, Dr Ahmed Jamaloodeen, Dr Xavagne Fransman and Dr Omphemetse Mathibe. Other collaborators include Dr Marian Tupy”, the company said..