Southern Cross University researchers have commenced Australia’s largest clinical trial investigating the efficacy of an over-the-counter botanical cannabidiol (CBD) product to help with sleep disturbance.
The trial, 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 33-45 per cent of Australians currently suffer from sleep disturbances which can impact both our physical and mental health, when left untreated,’ said Dr Janet Schloss, who is leading the investigation together with Associate Professor Romy Lauche.
‘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.
Despite an historic decision 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.
It is hoped this will change following the 1 February 2021 legalisation decision which will allow 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,’ stated 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,’ she said.
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 [email protected].