An Australian university has started a clinical trial investigating if an over-the-counter cannabidiol (CBD) product can assist with sleep disturbances.
Since February this year, certain cannabidiol products can be sold over-the-counter in Australia without a prescription by pharmacists. But given the stringent criteria associated with a Schedule 3 (S3) pharmacist-only classification, none are available as yet.
However, the race is on to be the first to market to tap into the pent-up demand in Australia for OTC CBD.
Targeting restless sleepers, Southern Cross University researchers have commenced a Phase IIb double blind, randomised, placebo-controlled, multi-site clinical trial funded Australia’s Ecofibre. Ecofibre subsidiary Ananda Hemp’s CBD extract in the form of a low-dose botanical CBD soft gel will be used in the trial and compared to a placebo.
“Approximately 33-45% of Australians currently suffer from sleep disturbances which can impact both our physical and mental health, when left untreated,” said lead investigator Dr Janet Schloss.
Dr. Schloss notes there have been no clinical trials on low-dose CBD to gauge effective dosing for sleep disturbances and studies such as this will add to the current evidence on cannabidiol generally available to pharmacists, doctors and patients.
Commenting on the challenges of getting a cannabis based S3 product to market in Australia, Ecofibre Chair Barry Lambert said:
“the process of undertaking S3 research and product registration is rigorous and lengthy, but we expect in the future this will be a large, well-regulated and highly accessible channel for Australian patients.”
438 participants will be involved in the trial – and researchers are still recruiting. The researchers are looking for generally healthy people aged 18-65 who are experiencing issues such as difficulties initiating sleep, staying sleep, or are waking earlier than desired.
An online screening survey can be accessed here.
Given the impact of COVID-19 and associated restrictions on Australians that have caused sleep deprived nights for many, no doubt there will be plenty of interest in participating.
This trial won’t be Dr. Schloss’s first cannabis related study – she was the lead researcher in a trial investigating if high THC medicinal cannabis can benefit glioma brain tumour patients.