CBD Study Recruiting Sleep Disorder Sufferers for Testing
Breakthrough Phase III Clinical Trial for CBD-Based Insomnia Treatment Underway in Australia
A groundbreaking Phase III clinical trial is currently underway in Australia, aiming to revolutionise the treatment of insomnia with the use of CBD. This trial, known as "The Trial," is being conducted by Avecho Biotechnology Limited and is the largest of its kind in the country, employing an ultra-pure synthetic CBD formulation.
The trial, which is sponsored by UK-based Chanelle McCoy Health, received ethics approval in August 2025 to commence the Phase III efficacy trial (CMH-CBD-001), using pharmaceutical-grade, FDA-registered synthetic CBD material. This follows successful Phase I safety and toxicity preclinical studies.
The trial is significant as it is the first Phase III CBD efficacy trial for insomnia in Australia, designed to demonstrate the effectiveness of oral CBD in improving sleep disturbances, eventually enabling Schedule 3 over-the-counter (OTC) availability without prescriptions.
Researchers are actively seeking to enroll 500 participants across Australia, making this the largest such trial for insomnia using CBD in the country. The trial is a placebo-controlled study, comparing nightly doses of Avecho's proprietary oral soft-gel capsules containing 75mg and 150mg cannabidiol with placebo over an 8-week period.
Avecho has developed a proprietary Tocopheryl Phosphate Mixture (TPM®) enhanced CBD soft-gel capsule to overcome challenges in CBD therapeutics such as limited bioavailability, pharmaceutical dosage form, and compound stability for an appropriate shelf-life.
The success of this trial could make Avecho Biotechnology Limited the first company to successfully register a pharmaceutical CBD product for sleep anywhere in the world. If successful, the product could become available over the counter at pharmacies in Australia, offering a key access and safety advantage over unregistered medicinal cannabis products.
The OTC opportunity for pharmaceutical CBD products was initially unique to Australia but has been adopted by New Zealand as well. Insomnia affects between 10-30% of the global population, with 10-15% classified as chronic. In Australia, almost 60% of the population reports insomnia symptoms. The policy change by the TGA in 2020 offers a significant advantage in addressing this widespread issue.
Insomnia in Australia contributes to an estimated total cost of $19.1 billion to the economy, with productivity losses accounting for $11 billion. This trial is positioned to meet the high demand in Australia for safe, effective non-prescription sleep aids, addressing widespread sleep disturbance issues.
Dr. Paul Gavin, CEO of Avecho, expressed excitement about working with a team of clinical experts across Australia for the Phase III Clinical Trial of Avecho's TPM®-enhanced CBD soft-gel capsule for insomnia treatment. For more information, visit avecho.com.au.
