Australia’s first clinical practice guideline for psychedelics released for public consultation

CMUS team, Faculty of Pharmacy and Pharmaceutical Science

5 August 2025

A new Australian Clinical Practice Guideline for the appropriate use of methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP) to treat post-traumatic stress disorder (PTSD) has been released for public consultation.

In 2023, Australia became the first country to reschedule MDMA from a Prohibited Substance (Schedule 9) to a Controlled Substance (Schedule 8) for the treatment of PTSD. This has allowed authorised psychiatrists to administer MDMA for the treatment of PTSD outside of clinical trials.

Monash University's Centre for Medicine Use and Safety (CMUS) and Neuromedicines Discovery Centre (NDC) have developed the Guideline to support clinicians and people living with PTSD to make informed decisions about MDMA-AP.

The 18-member Guideline Development Group comprised people with expertise in general practice, health economics, knowledge translation, law, lived experience of MDMA and PTSD, mental health policy, nursing, neuroscience, pharmacology, pharmacy, psychiatry, psychology, and psychotherapy.

Guideline development was also supported by a 21-person Expert Group, which included clinicians and patients with direct experience providing and receiving MDMA-AP. Seventeen stakeholder organisations were engaged throughout the development process, including professional societies, government agencies, not-for-profit, and consumer organisations.

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