Scientists at Southern Cross University in Australia have launched a large clinical trial assessing the potential of over-the-counter botanical cannabidiol (CBD) products to treat sleep disturbances in healthy subjects.
A compound found within the cannabis plant, CBD possesses no psychoactive properties.
Recent research has shown that CBD can help improve sleep disturbance symptoms and mood.
Funded by domestic hemp company Ecofibre, the trial will analyse the efficacy of its Ananda Hemp CBD extract versus placebo in subjects with self-reported alterations in sleep disturbances.
The randomised, placebo-controlled trial aims to enrol a total of 438 healthy subjects aged 18 to 65 years at four sites in Lismore, Brisbane, Sydney and Melbourne.
The subjects will include those with self-reported poor sleep, including people with problems related to starting and maintaining sleep or those who wake up earlier than preferred.
In the initial stage, each subject will receive the product for two weeks to detect the accurate dosage followed by treatment for eight more weeks to assess the quality of sleep and their wellbeing.
Trial lead investigator Dr Janet 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.”
In December 2020, the Therapeutic Goods Association (TGA) down-scheduled some low-dose CBD products to a Schedule 3 (pharmacist-only medicine) from a Schedule 4 (prescription medicine).
The latest trial follows Australian legalisation announced earlier this year permitting the over-the-counter purchase of products with CBD as a pharmacist-only drug.
According to The Sleep Foundation, poor quality sleep can damage the immune response and could cause flare-ups of various chronic illnesses and diseases.