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.
The results of ongoing clinical trials will establish an evidence base for medicinal cannabis and inform future treatment decisions.
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.
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).
Research on medicinal cannabis
The current research aims to establish which cannabis compounds and dosage levels are effective, and for which conditions and symptoms.
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.
Clinical trials are research investigations in which people volunteer to test new medications and treatments as a means to manage various medical conditions.
There are 2 schemes under which clinical trials involving therapeutic goods, including medicinal cannabis may be conducted in Australia:
Research is underway both in Australia and internationally to clinically trial a range of medicinal products, visit the Australian New Zealand Clinical Trials Registry
When making an application to the TGA, you will need to reference clinical evidence that supports using the specific type of medicinal cannabis product proposed (e.g. THC, CBD, or THC and CBD in combination) for your patient’s medical condition or symptoms.
Medicinal cannabis products are classified as either Schedule 3, Schedule 4 or Schedule 8 controlled substances, most products are not listed on the Australian Register of Therapeutic Goods (ARTG). In circumstances where patients need access to therapeutic goods that are not included in the ARTG, a Therapeutic Goods Administration (TGA) approval is required in order for the medicine to be prescribed.
In Queensland, the Medicines and Poisons (Medicines) Regulation 2021 describes the requirements for prescribing and dispensing S4 and S8 medicines.
Guidance and regulations
As most medicinal cannabis products are currently unregistered medicines, access to these products is through the Commonwealth Special Access or Authorised Prescriber Schemes or through a Clinical Trial.