More high-quality evidence needed to address misinformation and reduce fears towards psychedelics to treat mental health conditions

The study, published in Public Health Research & Practice and led by BehaviourWorks Australia and the Neuromedicines Discovery Centre within the Monash Institute of Pharmaceutical Sciences (MIPS), found a perceived insufficiency of evidence was preventing support for widespread clinical implementation of psychedelics in Australia.

State and Federal politicians representing both major and minor political parties also consistently mentioned that negative stigma prevented them and their peers from supporting the medical use of psychedelics in Australia.

The interviews took place between September 2022 and January 2023, before the Therapeutic Goods Administration (TGA) landmark decision to approve the use of MDMA (the active ingredient in ecstasy) and psilocybin (the active ingredient in magic mushrooms) for the treatment of post-traumatic stress disorder (PTSD) and treatment-resistant depression, respectively.

At the time the study was conducted, psychedelics were classified as Schedule 9 (prohibited substances). However in February 2023 the TGA reclassified psilocybin and MDMA from Schedule 9 to Schedule 8 (Controlled Drugs) due to “the current lack of options for patients with specific treatment-resistant mental illnesses.”

Prescribing is limited to authorised psychiatrists.

BehaviourWorks Australia Research Fellow and lead author on the study, Dr Brea Kunstler, said although reclassification is an important step towards including psychedelics in treatment regimens, the success of any innovation requires the support of those who might be impacted by it, including those who manage, deliver and use the medication. According to Dr Kunstler,

“The decades-long accumulation of negative stigma surrounding the use of psychedelic drugs, including MDMA and psilocybin, makes it very difficult for legislators and other decision makers to break the shackles to support the prescription of medicines containing these substances."

“Key organisations and politicians affected by the TGA’s decision want more information about psychedelics. They want credible and trustworthy information created using high-quality research evidence that is delivered by people with lived experience of treatment-resistant mental health conditions, and trusted entities such as doctors and scientists.”

Professor Chris Langmead, Director of the Neuromedicines Discovery Centre and a co-author of the study, said the past decade has seen a revival of interest in the potential of psychedelics such as psilocybin and MDMA as fast-acting and potentially more effective treatments when delivered in conjunction with supportive psychotherapy, and the mounting evidence to back it up.

“There have now been numerous clinical trials into the use of MDMA and psilocybin for mental health conditions, including PTSD, major depressive disorder, substance use disorders and anorexia nervosa."

“However, evidence still needs to be bolstered and clearly communicated, which was strongly emphasised in the report. In particular, stakeholders want to see research that focuses on the pathway for implementation, cost-effectiveness and equity, as well as the delivery and production feasibility within the Australian context - which are all extremely important and valid points.”

The TGA decision was a significant one, opening Australia up to world-first opportunities in this space. But much about psychedelic therapeutic use in Australia is still unknown, including where pharmaceutical-grade psychedelics will be obtained, how they will be regulated, and the costs and potential subsidies for these medicines and associated therapies. 

BehaviourWorks Australia Research Fellow and a study co-author Dr Melissa Hatty said these unknowns highlight the current lack of clarity around what the provision of psychedelic-assisted psychotherapy will look like in Australia and who will be able to access it.

“Prospective research is needed now that psychedelics can be prescribed to truly understand their impact in treating mental health conditions in Australia, including their associated economic and societal costs and/or benefits."

“In the short-term, high-quality review-level evidence is required to address misinformation and reduce fears related to the perceived negative effects of psychedelics.”

Changes to the classification of MDMA and psilocybin is an opportunity to pave the way toward breaking a 50-year drought in the development of new safe and effective medicines for a range of difficult-to-treat mental health conditions. However, progress has been slow due in part to the limited resources invested in research, and the legal restrictions that have constrained the use of psychedelic medicines.

The purpose of the Neuromedicines Discovery Centre is to create step-change in the field by taking a multi-disciplinary approach to the problem and working at scale, in a carefully coordinated and scientifically rigorous manner.

Other study authors from Monash’s BehaviourWorks Australia, which sits within the Monash Sustainable Development Institute, include Professor Liam Smith, Dr Denise Goodwin and Dr Brenna Wright.