Posted: 9 January 2023
Avecho Biotechnology Limited has announced that it has now received ethics approval for our Phase III clinical trial, testing oral CBD softgel capsule for insomnia.
Avecho is on track to commence the largest randomised, placebo controlled study being undertaken in Australia, to support registration of cannabidiol as an over-the-counter medicine with the Therapeutic Goods Administration (TGA).
Under the study design, which has been developed in consultations with a number of international sleep experts, patients will be enrolled across three treatment groups to compare nightly CBD doses of 75 and 150 mg CBD with placebo over an 8 week dosing period. The study will measure the effects of the treatments on reductions in insomnia severity, as measured by the Insomnia Severity Index (ISI), and subjective sleep efficiency. Additional data will be collected on other objective and subjective aspects of sleep.
