Southern Cross University researchers have commenced Australia’s largest clinical trial investigating the efficacy of an over-the-counter medicinal cannabis product to help with sleep disturbances.
Dr Janet Schloss is the lead investigator together with Associate Professor Romy Lauche, Deputy Director of Research from the National Centre for Naturopathic Medicine.
The trial of the botanical cannabidiol (CBD), funded by Australian hemp company Ecofibre, will compare the effects of their Ananda Hemp CBD extract to a placebo on participants’ self-reported changes in sleep disturbances.
“Approximately 33% to 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,” said Dr Schloss.
“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,” said Ananda Hemp’s Vice President Global Accounts, Georgie Rist.
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The Sleep Foundation has also emphasised the importance of sleep in helping to fight off infection. The Foundation has noted that when sleep is of poor quality, it can impair the immune response. In addition, poor sleep might result in ‘flare-ups’ of other chronic illness and disease.
After a historic decision made in December 2020, when the TGA (Therapeutic Goods Association) down-scheduled CBD to a Schedule 3 (Pharmacist Only Medicine) from a Schedule 4 (Prescription Only Medicine), there are still no TGA-approved CBD products that pharmacists can prescribe.
This exciting clinical research comes after the 1 February 2021 legalisation in Australia allowing the purchase of CBD-containing products over the counter as a pharmacist-only medicine.
“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.”
How to participate
Researchers are seeking generally healthy individuals aged 18-65 years old, who have self-reported poor sleep. This may include people who have difficulty initiating sleep, maintaining sleep, or are waking earlier than desired. Participants can partake in the trial in Melbourne, Sydney, Brisbane or Lismore. In total, 438 participants will be included in the trial, each participating in the trial for 10 weeks.
For further information about the trial, or to complete the online screening survey, visit https://redcap.link/h1m0851q or email ncnmtrials@scu.edu.au.
