Our sleep experts are looking for people across Australia to participate in an online-only cannabis insomnia clinical trial, which will test whether cannabidiol (CBD) is able to effectively reduce insomnia symptoms.
The CANRest study, being delivered in partnership with Bod Australia, will test CBD over 8 weeks in 200 participants through online and telephone contact, with no face-to-face visits.
Insomnia symptoms occur in about one in three adults, affecting emotional, social and physical wellbeing. The current treatments include improving sleep habits, behavioural therapy, and sleep medications. Unfortunately, many of the sleep medications have potential dependency and abuse issues or other undesirable side effects.
The Woolcock’s senior trial investigator, Professor Ron Grunstein AM, says Australians have become increasingly interested in the use of cannabis for medicinal purposes, but to date, there have been very few well-designed clinical trials showing the effectiveness of a pharmaceutical-grade formulation of CBD for insomnia.
"What we hope to achieve with the CANRest sleep study is to establish that the trial drug significantly improves quality and quantity of sleep for these patients compared with placebo," he says.
The cannabis sativa plant consists of more than 100 different plant cannabinoids, with the most common being delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is primarily responsible for its intoxicating effects, whereas CBD does not possess any intoxicating effects. CBD has been previously observed to improve sleep in small trials.
The Therapeutic Goods Administration that approves all medicines in Australia has, in principle, approved up to 150 mg per day CBD-containing products to be supplied over-the-counter by a pharmacist, without a prescription (Schedule 3). However, there are currently no specific products yet approved to be accessed in this way.
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Professor Grunstein says the CANRest study has been designed to prove whether there is real hope for CBD as a treatment for insomnia.
"There is a lot of hype about cannabis derivatives, but our patients need hard, high-quality evidence about the clinical value of these drugs in insomnia. Trials like CANRest are critical in providing such evidence," he says.