MDMA-AP for PTSD clinical practice guideline — consultation open

Australia became the first country, in 2023, to reschedule methylenedioxymethamphetamine (MDMA) from a Prohibited Substance (Schedule 9) to a Controlled Substance (Schedule 8) for the treatment of post-traumatic stress disorder (PTSD) — allowing authorised psychiatrists to administer MDMA for the treatment of PTSD outside of clinical trials. Now, a new Australian clinical practice guideline for the appropriate use of MDMA-assisted psychotherapy (MDMA-AP) to treat PTSD has been released for public consultation.

The guideline was developed by Monash University’s Centre for Medicine Use and Safety (CMUS) and Neuromedicines Discovery Centre to support clinicians and people living with PTSD to make informed decisions about MDMA-AP. The Guideline Development Group consisted of 18 members and was comprised of 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.

A 21-person Expert Group also supported the guideline’s development and included clinicians and patients with direct experience providing and receiving MDMA-AP. There were also 17 stakeholder organisations — including professional societies, government agencies, not-for-profit and consumer organisations — engaged throughout the development process. “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,” said Professor Simon Bell, CMUS Director and Guideline Clinical Chair. “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% of Australians will experience PTSD at some point in their lives.”

Four recommendations for clinical practice, 18 good practice statements and 11 recommendations for future research are included in the draft guideline. Public consultation is open until 31 August and the guidelines has been released on the digital platform MAGICapp. You can provide feedback via MAGICapp or using this form.

Image credit: iStock.com/Bojan89