Southern Cross University researchers have begun a clinical trial funded by Ecofibre to investigate the efficacy of the firm’s Ananda Hemp CBD extract in treating sleep disturbance with a view to registering it as an over-the-counter medicine.
Led by clinical trials fellow Dr Janet Schloss and deputy director of research at the National Centre for Naturopathic Medicine associate professor Romy Lauche, the trial will test the effects of Ananda Hemp on participants’ sleep patterns compared to a placebo.
Dr Schloss said around 33-45% of Australians currently suffer from sleep disturbances, impacting both physical and mental health when left untreated.
Ananda Hemp vice president global accounts Georgie Rist added: “Given many Australians are reporting less quality sleep during current lockdowns across the country, there has never been a more important time to help with such an essential, yet often neglected, aspect of their health.”
The move comes after the Therapeutic Goods Administration (TGA) announced plans to down schedule low-dose CBD to a S3 (over-the-counter) medicine from February 1, 2021. In order to sell products in pharmacies without a script, companies will need to have them approved by the TGA and listed on the Australian Register of Therapeutic Goods.
Dr Schloss said: “Currently there are no registered CBD products that pharmacists can dispense [without a script], even though it has been rescheduled and thus approved for over-the-counter sales.”
“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.”
Researchers are seeking 438 generally healthy individuals aged 18-65 who have self-reported poor sleep — difficulty initiating or maintaining sleep, or waking earlier than desired.
Participants will join the trial in Melbourne, Sydney, Brisbane or Lismore for 10 weeks. For more information, click here.