Medical cannabis giant Bod Australia (ASX: BDA) is about to undertake a Phase IIB clinical trial to test the effectiveness of a new CBD medication on insomnia.
Bod will conduct the trial at Australia’s leading sleep and respiratory research organisation: the Woodcock Institute of Medical Research. The trial will include roughly 200 people aged 18 – 65 who have insomnia. In the trial, participants will take a placebo drug and Bod’s new CBD medication in 50mg and 100mg doses. Researchers will then assess the severity of their insomnia using the insomnia severity index. The index specifically analyses whether people have trouble falling asleep, staying asleep, and waking up too early.
Throughout the trial, neither the participants nor the researchers will know which medication participants are on. This will allow researchers to compare the effectiveness of the CBD medication to the placebo drug for eight weeks (though the trial will span 12 weeks in total). The trial will also analyse participant’s anxiety and stress levels.
While we don’t often speak about insomnia, it affects the lives of many Australians. According to the Sleep Health Foundation, 59.4% of Australian adults suffer from at least one symptom that makes sleep difficult, while 14.8% have symptoms that meet the criteria for an insomnia diagnosis.
Many people with insomnia also struggle to treat their symptoms — as the type of medications that help someone sleep better can also make it difficult to work, drive, and stay awake throughout the day. Some of these medications are also addictive and come with nasty side effects.
Naturally, the global market for insomnia treatments is expected to be worth $5.48 billion by 2023. There is also a “need for alternative treatments”, according to the Woolcock Institute’s Head of Sleep and Circadian Research Professor Ron Grunstein.
Given the need for alternative treatments for insomnia, it is critical to investigate the effect of CBD on sleep through a high-quality study.
Bod Australia will patent the drug and bring it to market through licencing agreements with other companies at the end of the Phase IIB trial. Bod intends to launch the medication onto the Schedule 3 CBD market — meaning it will be available over-the-counter in pharmacies. This market is currently valued at around $250 million.