Australia

The landscape of psychedelic medicine in Australia has undergone significant changes recently. While the majority of psychedelics remain illegal, the Australian government has recognized the therapeutic potential of certain substances. In early 2023, the Therapeutic Goods Administration (TGA) reclassified MDMA and psilocybin from Schedule 9 Prohibited Substances to Schedule 8 Controlled Drugs. This change allows authorized psychiatrists to prescribe MDMA for the treatment of post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression, starting from July 1, 2023.

This regulatory shift marks Australia as the first country to legalize the medical use of these psychedelics at a national level. However, this access is strictly controlled. Only psychiatrists with specific qualifications and approvals can prescribe these substances, and they must adhere to evidence-based treatment protocols approved by a human research ethics committee. To date (August 2024), only a handful of prescriptions have been made.

Despite these advancements, the uptake of psychedelic treatments has been slow, primarily due to barriers such as the high cost of treatment, estimated between USD $15,000 and $23,500 for a standard three-session treatment, and the lack of standardized training programs for clinicians. Additionally, Australia’s first dedicated psychedelic therapy clinic has opened, highlighting the cautious approach taken due to the many unknowns and the need for more research to understand the efficacy and safety of these treatments fully.

Psychedelics in Australia Today

In August 2020, the Green Party in the Australian Capital Territory (ACT) committed to supporting the introduction of regulated psychedelic therapies as part of its drug law reform election platform. Although the Therapeutic Goods Administration (TGA) changes at the start of the year were not honoured, more money is going towards research that could provide evidence for allowing the therapeutic use of psilocybin in Australia.

Mind Medicine Australia (MMA) initially donated money to St Vincent’s Hospital, Melbourne, for a psilocybin study of anxiety in terminally ill cancer patients. However, after a disagreement, this money was returned. The St Vincent’s trial has now been completed.

This effort is greatly assisted by the recent AU$15 million Medical Research Future Fund (MRFF), a competitive grant launched in January 2022. The money will be used to fund seven clinical trials in Australia using psilocybin, MDMA, and other psychedelics.

The largest of the grants, more than $3.8 million, will go to two research teams at the University of Sydney. One group, led by Kirsten Morley from the Faculty of Medicine and Health, will examine the efficacy of MDMA-assisted therapy to treat combined alcohol use disorder and PTSD. Separately, another group has been awarded funding to conduct a trial exploring the effects of psilocybin-assisted therapy for the eating disorder anorexia nervosa.

The Clinical Psychedelic Research Lab at Monash University is Australia’s first research group dedicated to the study of psychedelics, and pioneering a rigorous program of research and training in psychedelic therapies. Led by Dr Paul Liknaitzky, the lab is focused on investigating novel applications for psychedelic therapies, translating evidence into best clinical practice, exploring and mitigating under-examined risks, delivering next-generation therapist training, and improving access and affordability.

Key Organisations

Psychae Institute is a non-profit research initiative dedicated to developing psychedelic therapies. Headquartered in Melbourne, Australia, research contributions will be made by a prestigious global network of researchers from institutions such as the University of Toronto, Imperial College London, the University of Zurich and the Federal University of Rio Grande in Brazil, amongst others.

Incannex Healthcare is working with Dr. Paul Liknaitzky and his team at Monash University on the PsiGAD trial, which explores the effects of psilocybin-assisted psychotherapy for treating Generalized Anxiety Disorder (GAD). The Phase 2 PsiGAD-1 trial showed promising results, with psilocybin demonstrating a significant reduction in anxiety symptoms compared to placebo. Following these results, Incannex is preparing for a Phase 2B trial to be conducted at multiple sites in the United States and the United Kingdom.

Melbourne-based MindBio Therapeutics is collaborating with researchers at the University of Auckland on a Phase I clinical trial exploring the effects of microdosing LSD for the treatment of depression. The company is also conducting a Phase 2a trial using its proprietary LSD formulation, MB22001, for depression (MDD), and plans to assess the effects of microdosing LSD in tandem with psychotherapy in late-stage cancer patients.

Mind Medicine Australia is a charity focused on expanding the availability of psychedelic-assisted therapies to alleviate mental illness in Australia. Over the past five years, MMA has made significant strides in raising public awareness and advocating for the rescheduling of MDMA and psilocybin for medical use. They have successfully lobbied for the Therapeutic Goods Administration (TGA) to reclassify these substances, allowing limited access to MDMA and psilocybin-assisted therapies since July 1, 2023. MMA has also developed extensive educational resources, hosted international summits on psychedelic therapies, and established partnerships with universities for training and research.

Psychedelic Institute Australia offers high-quality training and education in psychedelic therapy for therapists and clinicians. The organization provides workshops, online courses, and in-person training programs led by experienced researchers and clinicians involved in psychedelic clinical trials. PIA is committed to advancing the safe and effective use of psychedelic substances in therapeutic contexts through rigorous training and consultancy services.