Large Clinical Trial Begins in Australia to Investigate CBD Oil for Sleep
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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.
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