Clinical guide for MDMA PTSD treatment released

The world’s first clinical practice guide on the use of methylenedioxymethamphetamine (MDMA) with psychotherapy for treating post-traumatic stress disorder (PTSD) has just been published.
 
In 2023, the Therapeutic Goods Administration (TGA) rescheduled MDMA from a Schedule 9 substance to Schedule 8, paving the way for authorised psychiatrists to administer it for the treatment of PTSD outside of clinical trials.
 
Authors of the guideline on MDMA-assisted psychotherapy (MDMA-AP), which was compiled by Monash University, say it is aimed at GPs and other health professionals who are involved in managing patients with PTSD.  
 
They do not recommend the treatment as part of routine care and state that it should be limited to patients over the age of 18 who have been diagnosed with PTSD and have had symptoms for at least six months, including moderate to severe ones in the past month.
 
They should also have had ‘an adequate trial of first-line evidence-based treatments and are not likely to be re-exposed to the index or other significant trauma during treatment’.
 
The guideline follows an announcement by the Federal Government last November that it would fund the treatment for eligible veterans with a confirmed PTSD diagnosis. 
 
Dr Karen Spielman, Chair of RACGP Specific Interests Psychological Medicine, described the guideline as ‘really sensible and really thorough’.
 
A good-practice statement, which emphasises the role of GPs in shared care and that MDMA-AP ‘should be integrated into, rather than replace, a patient’s broader treatment plan’ is another area of the guideline that resonated with Dr Spielman.
 
Dr Spielman notes that availability of the treatment is likely to be limited for now because of how recently regulations have changed, the limited number of psychiatrists trained so far, as well as the expense, but believes GPs ‘have a very important role that will develop’.
 
She emphasised the importance of GPs working closely with psychiatrists.
 
‘It will enhance the outcomes if there’s really good, solid collaboration,’ she said.
 
‘Certainly with my patients, I’ve found it very useful to be involved in the coordination.
 
‘The GPs in all of these situations have a really important role to manage medical suitability, to keep a steadying eye on the overall progress, to understand where it fits in with overall care, to escalate up and down, to check in with safety, to be involved long term.’
 
The guideline also ‘strongly recommends’ against its use among patients who have been excluded from existing clinical trials for safety reasons.
 
These include those who are pregnant or breastfeeding, with cardiovascular disease, psychotic disorder, suicide-related distress as well as those using medications which may interact with MDMA.
 
Acknowledging the field of MDMA-assisted therapy is ‘rapidly evolving’, the authors of the guideline said they plan to review it within five years, and that it may be updated earlier if new evidence becomes available.
 
‘The guideline addresses an important need because nearly half of people with PTSD do not improve with current treatments,’ said project-manager Dr Alene Yong from Monash University’s Centre for Medicine Use and Safety.
 
‘Although MDMA-AP is now available in selected private clinics, knowledge gaps remain regarding the translation of research evidence into clinical practice.’
 
The guideline has also been approved by National Health and Medical Research Council. 
 
Log in below to join the conversation.

MDMA NHRMC psychotherapy PTSD