New guidelines don’t recommend routinely using the stimulant for PTSD, but leave the door open and give advice if that’s the path chosen.
Doctors have been asked to give feedback on new draft clinical practice guidelines on the use of MDMA-assisted psychotherapy for PTSD.
The Monash University-led guidelines give a conditional recommendation not to routinely use MDMA-AP for PTSD, which the authors say is based on a consideration of the benefits, harms, strength of evidence, patient preferences, resources, equity, acceptability and feasibility.
However, if it is used, the treatment should only be available to adults with PTSD symptoms that have endured for at least six months following their diagnosis, and who have had moderate or severe PTSD symptoms in the past month.
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Patients should have adequately trialled first-line evidence-based treatments before trying MDMA-AP and be at low risk of being re-exposed to trauma during treatment, said Professor Simon Bell, director of the university’s Centre for Medicine Use and Safety (CMUS) and the guideline clinical chair.
“In making a draft conditional recommendation, the guideline development group is really reflecting the fact that opinion is varied,” Professor Bell told The Medical Republic.
“So even when presented with the same information about benefits and harms of treatment, then we believe that people will make a different decision about whether to choose or not choose MDMA-assisted psychotherapy.”
That variability highlighted the importance of a shared decision-making approach, he said.
GPs were a vital part of the process, as they would be the ones to respond to patients’ questions, refer on, and help to manage the patient during and after the treatment.
“To ensure continuity of care, people who provide MDMA-AP should do so in consultation with the person’s regular healthcare providers (e.g., general practitioners, psychologists, psychiatrists, therapists),” Professor Bell and colleagues wrote.
“MDMA-AP should be integrated into, rather than replace, a patient’s broader treatment plan. Where possible, a designated provider (such as the patient’s usual general practitioner) should remain primarily responsible for overall patient care.”
Professor Bell said that treatment may first involve tapering or ceasing some medication, such as antidepressants and opioids, and called for more training of the health workforce to ensure practitioners had relevant and evidence-based information.
Clinical uncertainty and increasing demand for information within the community drove the group to create a guideline.
“It’s been estimated that up to 11% of Australians will experience PTSD at some point in their lives,” Professor Bell said.
“And yet, nearly half of people with PTSD don’t improve with the current evidence-based treatments – so there’s a need for both new and innovative therapeutic interventions, but also a need for information about those interventions.”
According to Professor Bell, existing studied tended to use small sample sizes, were unblinded or were difficult to generalise.
“The consultation that we did with people with lived experience suggests that different people would choose to accept or not accept MDMA assisted psychotherapy, even when presented with that low or very low certainty evidence in relation to some of those benefits,” he said.
The authors strongly recommended against using MDMA-AP in groups who haven’t been studied due to safety reasons. This included people who were pregnant or breastfeeding, had CVD, psychotic disorder, suicide-related distress and people using medications that could interact with MDMA.
They also made several good practice statements to help improve treatment delivery.
“People living with PTSD have varying values, preferences, and lived experiences that should be central to the planning and delivery of MDMA-AP,” they wrote, adding that care should be responsive to these individual needs and accommodations.
Clinicians needed to ensure the benefit to risk ratio was high, by screening patients first for medical, psychiatric, psychological, financial and social considerations.
The treating doctor should also explain to potential patients that there is only limited evidence on the safety and efficacy of this treatment, and give them comprehensive information on what to expect before, during and after treatment.
“Clinicians and people with lived experience of PTSD reported that some patients who have trialled established PTSD treatments without success may overestimate potential benefits and minimise potential risks,” Professor Bell and colleagues wrote.
The authors also encouraged clinicians to declare any potential conflicts of interest as part of obtaining informed consent for the treatment.
Australia was the first country to down-schedule MDMA to an S8 drug, allowing authorised psychiatrists to provide the treatment for PTSD outside of trials.
The authors made clear that the guideline didn’t address the general management of PTSD, the use of MDMA without psychotherapy or the use of this approach in other conditions.
Feedback can be provided using this form, until 31 August 2025.
