A new Australian Clinical Practice Guideline for the Appropriate Use of Methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP) for Post-Traumatic Stress Disorder (PTSD) has been approved by the National Health and Medical Research Council (NHMRC).
The Guideline is the world’s first related to MDMA-AP to be developed using the gold standard Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
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) developed the Guideline to support clinicians and people living with PTSD to make informed decisions about MDMA-AP. CMUS Director and Guideline Chair, Professor Simon Bell, said the Guideline includes four recommendations, 21 Good Practice Statements and 15 research recommendations.
This timing comes as the government announced in November last year that MDMA-AP will now be reimbursed for post-traumatic stress disorder (PTSD) for eligible veterans. For some people, including groups such as veterans and first responders, new treatment pathways provide important hope.
“The Guideline is based on consideration of benefits and harms, certainty of the evidence, patient values and preferences, resources, equity, acceptability, and feasibility,” Professor Bell said.
“MDMA-AP is not considered a routine treatment for PTSD. If MDMA-AP is used, the 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. The use of MDMA-AP should also be limited to those who have received an adequate trial of first-line evidence-based treatments, and be at low risk of being re-exposed to the index 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. Although MDMA-AP is now available in selected private clinics, knowledge gaps remain regarding the translation of research evidence into clinical practice.”
“The Guideline strongly recommends against the use of MDMA-AP in patient groups who have been excluded from existing clinical trials for safety reasons. These patient groups include but are not limited to those who are pregnant or breastfeeding, with cardiovascular disease, psychotic disorder, suicide-related distress (i.e., currently experiencing suicidal thoughts and/or behaviour), and people who are currently using medications that may interact with MDMA,” Dr Yong said.
The Guideline is mainly intended for clinicians, including general practitioners, nurses, pharmacists, psychiatrists, psychologists, therapists, and other medical/allied health professionals involved in the management of PTSD. A Companion Guide is being developed for people living with PTSD, their families and carers.
The Guideline addresses the rapidly emerging field of MDMA-assisted therapy, where clinical uncertainty exists regarding what constitutes best practice, and there are heightened risks of misinformation or disinformation among consumers.
The Guideline was supported by philanthropic funding to the Neuromedicines Discovery Centre, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University. Funding to develop the Guideline was also provided by Monash University, the University of Melbourne, and The Florey Institute of Neuroscience and Mental Health. The philanthropic donor had no role in the design, data collection and analysis, decision to publish, or preparation of the Guideline.
The Guideline is accessible: Here
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