Researchers from Southern Cross University in Lismore, Australia are setting up to carry out Australia’s largest clinical trial investigating the efficacy of CBD in reducing sleep disturbances.
The trial will be funded by the Australian hemp company, Ecofibre, comparing the potential of their over-the-counter hemp-derived CBD product (Ananda Hemp CBD) to a placebo. Researchers will assess the self-reported changes in sleep in patients using either treatment option.
Dr Janet Schloss, Clinical Trials Fellow, will lead the trial, alongside Professor Romy Lauche, Deputy Director of Research from the National Centre for Naturopathic Medicine.
Commenting on the trial, Dr Schloss said: “Approximately 33%-45% of Australians currently suffer from sleep disturbances which can impact both our physical and mental health, when left untreated.
“We are currently investigating if a low-dose botanical CBD soft gel will assist people with sleep disturbance compared to a placebo, which is an inactive substance.”
Sleep quality has become a recurrent topic of conversation in the last couple of years as a number of reports found the Coronavirus pandemic and resulting lockdowns had impacted the sleep of many people.
Georgie Rist, Ananda Hemp’s Vice President Global Accounts said: “Given many Australians are reporting less quality sleep during current lockdowns across the country, there has never been a more important time to help Australians with such an essential, yet often neglected, aspect of their health.”
The launch of the clinical trial comes over half a year after the introduction of legislation in Australia to allow the sale of over-the-counter CBD products. However, CBD products are currently only permitted to be sold as pharmacist-only medicinal products.
CBD was rescheduled by Australia’s Therapeutic Goods Association (TGA) at the end of last year. This historic decision moved the cannabinoid from Schedule 4, where a prescription was required for purchase, to Schedule 3, allowing for pharmacists to stock products containing the ingredient.
However, despite the change, no CBD products have yet been approved for over-the-counter purchase.
“Currently there are no registered CBD products that pharmacists can dispense, even though it has been rescheduled and thus approved for over-the-counter sales,” said Dr Schloss.
“Additionally, no clinical trials on low-dose CBD have been undertaken to see what amount works for sleep disturbances. Trials like this will add to the current evidence for pharmacists, doctors and patients which is important moving forward in this space.”
This trial will recruit a total of 438 participants from Melbourne, Sydney, Brisbane or Lismore for a total of 10 weeks. Participants will be aged between 18-65 years old and will experience self-reported poor sleep – this may include difficulties initiating sleep, maintaining sleep, or waking early.