Clinical trials and other research on medicinal cannabis
Clinical trials are research investigations in which people volunteer to test new medications and treatments as a means to manage various medical conditions.
Participants in clinical trials for medicinal cannabis will use pharmaceutical medicinal cannabis products approved by the Therapeutic Goods Administration (TGA) and the relevant Human Research Ethics Committee (HREC).
The results of ongoing clinical trials will establish an evidence base for medicinal cannabis and inform future treatment decisions.
There are 2 schemes under which clinical trials involving therapeutic goods, including medicinal cannabis may be conducted in Australia, the Clinical Trial Exemption scheme (CTX) and the Clinical Trial Notification scheme (CTN). These schemes are regulated by the Commonwealth Therapeutic Goods Administration.
Queensland Health approves all clinical research trials for medicinal cannabis. Appropriate conditions will be imposed on clinical trials.
Before granting a clinical trial approval, the chief executive must be satisfied that:
- the applicant is a suitable person to hold the approval
- the medicinal cannabis will be accessed and supplied as approved by the Commonwealth.
Current trials in Queensland
Compassionate access scheme
Compassionate access scheme: children with severe treatment-resistant epilepsy.
Paediatric epilepsy lambert initiative cannabinoid analysis (PELICAN)
Queensland Health commissioned The Lambert Initiative (University of Sydney) to evaluate current cannabinoid use for childhood epilepsy in the Queensland community. The project aims to:
- document the types and patterns of cannabinoid use for the treatment of childhood epilepsy in Australia
- understand the experiences of families involved in using – or not using –cannabinoids, including an assessment of the impact of cannabinoid use upon epilepsy and other health outcomes, sources of information and support, and key issues for families
- identify the chemical composition of cannabinoid preparations currently used in Australia for treatment-resistant childhood epilepsy.
The Pelican trial commences in March 2017 and was completed in November 2017, at the Centre for Children's Health Research.
Research on medicinal cannabis
There are many claims about the beneficial use of medicinal cannabis products for a wide range of conditions. Most of these claims lack solid scientific backing, because cannabis is an illegal drug and it has been difficult for researchers to run research trials.
The current research aims to establish which cannabis compounds and dosage levels are effective, and for which conditions and symptoms.
There are different types of cannabis, and these can contain over 400 various compounds in the raw form. We need to research cannabis products using known stable active components, so that treatment outcomes can be compared and replicated.
The 2 main active components that are the current focus of research are tetrahydrocannabinol (THC) and cannabidiol (CBD). However there are many other components that may be beneficial and will be the focus of research in the future.
Research is underway in other areas to clinically trial a range of medicinal products: