Australia's largest clinical trial of CBD oil for sleep begins at SCU - The Echo

Paul Bibby

Southern Cross University researchers have begun Australia's largest clinical trial to investigate the effectiveness of an over-the-counter botanical cannabidiol (CBD) in relieving sleep disorders.

The study, funded by the Australian hemp company Ecofibre, will compare the effects of their Ananda hemp CBD extract with a placebo on the participants' self-reported changes in sleep disorders.

Dr. Janet Schloss of SCU, Clinical Trials Fellow who is the lead investigator of the CBD oil study along with Associate Professor Romy Lauche, Assistant Director of Research for the National Center for Naturopathic Medicine.

"Approximately 33-45 percent of Australians currently have insomnia which, if left untreated, can affect both our physical and mental health," said Dr. Janet Schloss, who is leading the investigation with Professor Romy Lauche.

“We are currently investigating whether a low-dose herbal CBD soft gel can help people with insomnia compared to a placebo, which is an inactive substance.

Despite a historic decision in December 2020 when the TGA (Therapeutic Goods Association) downgraded the planned CBD from List 4 (prescription drugs) to List 3 (pharmaceuticals only for pharmacists); There are still no TGA-approved CBD products for pharmacists to prescribe.

It is to be hoped that this will change after the legalization decision of February 1, 2021, which enables the over-the-counter purchase of CBD-containing products as pharmaceuticals only for pharmacists.

"Currently there are no registered CBD products that can be dispensed by pharmacists, although this has been postponed and thus approved for over-the-counter sales," said Dr. Lock.

“Also, no clinical studies have been done with low-dose CBD to see what amount works for insomnia. Studies like this one will add to the current evidence for pharmacists, doctors and patients about what is important in this area, ”she said.

So take part

Researchers generally look for healthy individuals between the ages of 18 and 65 who say they have poor sleep.

This can include people who have difficulty initiating sleep, maintaining sleep, or waking up earlier than desired.

Participants can take part in the study in Melbourne, Sydney, Brisbane or Lismore. A total of 438 participants will be enrolled in the study, each of whom will participate in the study for 10 weeks.

For more information on the study or to complete the online screening survey, please visit https://redcap.link/h1m0851q or email .

https://thedailyhealthjournal.com/australias-largest-clinical-trial-of-cbd-oil-for-sleep-begins-at-scu-the-echo/