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.
CMUS Director and Guideline Clinical Chair Professor Simon Bell said, "The Guideline is based on consideration of benefits and harms, certainty of the evidence, patient values and preferences, resources, equity, acceptability, and feasibility. Taking these factors into account, the draft Guideline conditionally recommends against the routine use of MDMA-AP for PTSD."
"However, if MDMA-AP is used, the draft Guideline recommends it should be limited to adults (≥18 years old) with PTSD symptoms for at least six months post-diagnosis, with moderate or severe PTSD symptoms in the past month. Use of MDMA-AP should also be limited to those who have received an adequate trial of first-line evidence-based treatments first, and be at low risk of being re-exposed to trauma during treatment."
Project Manager Dr Alene Yong from CMUS said, "The Guideline addresses an important need because nearly half of people with PTSD do not improve with current treatments. The Australian Institute of Health and Welfare estimates that up to 11 per cent of Australians will experience PTSD at some point in their lives."
The draft Guideline includes four recommendations for clinical practice, 18 good practice statements, and 11 recommendations for future research. The Guidelines have been released on the digital platform MAGICapp. Feedback can be provided via MAGICapp or using this form. Public consultation is open until Sunday 31 August.
