Large Clinical Trial Begins in Australia to Investigate CBD Oil for Sleep
Ecofibre, an Australian hemp company, is funding the project. The goal is to determine if CBD extract reduces sleep disturbances.
Getting a good night’s sleep seems like an impossible task for many people, so it is exciting to see a large clinical trial begin to investigate CBD oil for sleep.
Researchers from Southern Cross University in Australia will conduct the trials. The lead investigator Dr. Janet Schloss explained,
“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.”
The clinical trials will involve giving half the participants a placebo and the other half the CBD softgel. Each person will self-report changes in sleep patterns. Should the trials demonstrate CBD does promote better sleep, it is hoped that one day legislators will allow the sale of over-the-counter pharmacist-prescribed CBD products.
Australian law has already moved CBD to the Schedule 3-Pharmacist Only Medicine Level, and a recent law was passed that allows the sale of low-dose cannabidiol for over-the-counter sale in Australian pharmacies without a doctor’s prescription. The products must be registered as S3 medicine which requires submitting a significant amount of data demonstrating the efficacy, safety and quality of a CBD product.
The best way to gain that data is through controlled clinical trials. The trials will involve 438 participants who are aged 18-65 years old and will be held at four locations in Australia. Participants have self-reported they experience poor sleep. Poor sleep experiences include falling asleep, staying asleep and/or waking up earlier than planned.
The trials will last for 10 weeks. The fact it is a clinical trial is critical. Clinical trials are conducted according to rigorous medical standards that include a randomized and placebo-controlled approach. This means the people participating in the trial will not know if they are taking a CBD soft gel or a placebo. The CBD industry needs more of this kind of research to determine if consumer anecdotal evidence is scientifically valid.