First clinical guide for MDMA-assisted psychotherapy

Public consultation is underway for Australia’s first clinical guidance for the appropriate use of MDMA-assisted psychotherapy (MDMA-AP) to treat post-traumatic stress disorder (PTSD), with the RACGP welcoming the opportunity to provide feedback.

Developed by Monash University’s Centre for Medicine Use and Safety (CMUS) and Neuromedicines Discovery Centre, the draft clinical practice guideline was developed to support clinicians and people living with diagnosed PTSD to make informed decisions.
 
While patients in Australia can access MDMA-AP in specific private specialist clinics, the authors say the efficacy of specific MDMA products has ‘not yet been established through the routine drug approval pathway’.
 
The draft guideline is designed to support clinical use by providing evidence-based recommendations, as well as address current gaps in knowledge and inform future research.
 
It follows 2023 changes that saw Australia become the first country to down schedule MDMA from a Schedule 9 to a Schedule 8 drug for the treatment of PTSD, allowing authorised psychiatrists to administer MDMA for the treatment of PTSD outside of clinical trials.
 
Now, experts including GPs, psychiatrists, and people with lived experience have developed the draft guideline, which comprises four recommendations for clinical practice and 18 ‘good practice’ statements based on the latest evidence.

Associate Professor Caroline Johnson sits on the RACGP Expert Committee – Quality Care and its Mental Health Working Group.
 
‘I am pleased the RACGP has had representation on the working group and will be providing feedback to the draft,’ she told newsGP.
 
And while she acknowledges it is not the subject of the draft guideline, Associate Professor Johnson says GPs have an important role to play in detection and management of patients with PTSD.
 
‘The main role for GPs in relation to this guideline is to support our patients who already have a diagnosis of PTSD,’ she said.
 
‘To do this, it is useful for GPs to be aware of the gradually emerging evidence about use of MDMA-AP, in order to respond appropriately to patient queries about this treatment option, and perhaps to selectively raise it as an option in very specific circumstances.’ 
 
In Australia, up to 10% of people are estimated to experience PTSD at some point in their lives.
 
While the Therapeutic Goods Administration’s decision to down schedule MDMA was met with mixed response from healthcare providers, experts described it as a ‘major shift’ in the way mental health conditions can be managed and positioned Australia as world-leading.
 
At the same time, the Royal Australian and New Zealand College of Psychiatrists released its first guidance document on psychedelic-assisted therapy. 
 
The team behind the new draft guideline believe it will help address gaps when patients experiencing PTSD do not improve with current treatments.
 
‘The guideline is based on consideration of benefits and harms, certainty of the evidence, patient values and preferences, resources, equity, acceptability, and feasibility,’ CMUS Director and Guideline Clinical Chair Professor Simon Bell said.
 
‘Taking these factors into account, the draft guideline conditionally recommends against the routine use of MDMA-assisted psychotherapy for PTSD. However, if it is used, the guideline recommends it should be limited to adults 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.’

The guideline does not address the use of MDMA as a stand-alone treatment without psychotherapy, use of MDMA-AP for mental health conditions other than PTSD, or the use of the drug obtained outside of clinical settings. 

Associate Professor Johnson says careful consideration should be taken when using the guideline and prescribing MDMA-AP, which ‘must be balanced against the need for a compassionate and supportive response’ to adults with PTSD who have adequately tried and not received benefit from more established evidence-based treatments.
 
‘Like other novel psychiatric treatments in history, there is the danger of the hype overtaking the evidence, and patients being put at risk by turning to solutions that may not yet have been adequately tested for their specific circumstances,’ she said.
 
‘These draft guidelines are a welcome step to putting some guardrails around the advice GPs might give, providing some clarity around the evidence gaps, including information about groups who have thus far been excluded from clinical trials.
 
‘The benefits of trying novel therapies in ethically approved research settings is also made clear and seems essential in the under 18 age group.’
 
Public consultation on the draft guideline is open until 5 September. A plan to review and update the guideline is set for the next five years, or earlier if new evidence becomes available that would change current recommendations.
 
Log in below to join the conversation.
 

MDMA mental health post-traumatic stress disorder psychedelic-assisted therapy psychotherapy PTSD