Appropriate use of MDMA-assisted psychotherapy for PTSD

Quick reference guide

Context

It has been estimated that up to 11% of Australians will experience PTSD in their lifetime. In July 2023, Australia became the world’s first country to reschedule MDMA from prohibited (Schedule 9) to controlled (Schedule 8) drugs, permitting it to be prescribed for the treatment of PTSD. To date, no MDMA-containing product has been approved by any regulatory agencies worldwide. Hence, there is a need to systematically examine the available evidence, consider potential benefits and risks, and provide clear guidance on its potential use. 

Key recommendations

1. Recommendation 1 (Conditional recommendation against)

For people living with PTSD, the Guideline Development Group does not recommend the routine use of MDMA-AP. If MDMA-AP is used, it should be limited to adults (≥18 years old) who:

• have had PTSD symptoms for at least 6 months duration post-diagnosis,
• have moderate or severe PTSD symptoms in the past month (CAPS-5 total severity score ≥28)
• have received 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.

Evidence from current clinical trials relates to a single course of MDMA-AP (3 dosing sessions, 80-120mg MDMA with optional supplemental half dose at each dosing).

2. Recommendation 2 (Only in research settings)

Do not use MDMA-AP for the treatment of PTSD outside of clinical trials with appropriate ethical approval in people less than 18 years old.

3. Recommendation 3 (Only in research settings)

Do not use MDMA-AP for the treatment of PTSD outside of clinical trials with appropriate ethical approval in people who 1) have not had PTSD symptoms for at least 6 months duration post-diagnosis; 2) did not have at least moderate PTSD symptoms in the past month (CAPS-5 total severity score ≥28); 3) have not received an adequate trial of first-line evidence- based treatments; or 4) are likely to be re-exposed to the index or other significant trauma during treatment.

4. Recommendation 4 (Strong recommendation against)

For people living with PTSD, the Guideline Development Group 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 (e.g., uncontrolled hypertension, cardiac arrhythmia), 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.

Target audience

The Guideline is primarily for healthcare professionals involved in the management of PTSD (e.g., counsellors, general practitioners, nurses, pharmacists, psychiatrists, psychologists, therapists, and other medical/allied health professionals). People living with PTSD and other interested members of the public are also welcome to read the Guideline.

Implementation considerations prior to initiating MDMA-AP

Good Practice Statement 1

People living with PTSD have varying values, preferences, and lived experiences that should be central to the planning and delivery of MDMA-AP. Trauma-informed, participatory, and culturally-responsive care should be planned using a shared decision-making approach between the clinicians and patients. Care should be responsive to the needs of individuals from diverse cultural backgrounds, neurodivergent communities, and other priority populations. Clinicians and services should apply core trauma-informed care principles, including safety, trustworthiness and transparency, peer support, collaboration and mutuality, empowerment, and recognition of cultural, historical, and gender issues. Integrating MDMA-AP into a trauma- informed model of service delivery ensures that treatment is provided in a way that minimises the risk of re-traumatisation, supports patient autonomy, and promotes healing within a safe and responsive therapeutic environment.

Good Practice Statement 2

Prior to initiating MDMA-AP, appropriate medical, psychiatric, psychological, financial, and social screening should be conducted by the treating psychiatrist to maximise potential benefits and minimise potential harms. Screening should include careful assessment of symptoms of dissociation and psychosis, substance use, trauma history, suicidal thoughts and self-harm risk, and potential contraindications related to cardiovascular, neurological, or psychiatric conditions. Given the risk of MDMA in causing prolonged QT interval and increased blood pressure, an ECG should be performed prior to commencing treatment. It is the authorised prescriber’s responsibility to refer to relevant medical and prescription records before prescribing MDMA to ensure patients are not on any medications that could potentially interact with MDMA or are indicative of conditions that contraindicate MDMA use. All findings from the screening process should be documented in appropriate records.

Good Practice Statement 3

Prior to initiating MDMA-AP, the treating psychiatrist is responsible for explaining to potential patients that the current evidence on the efficacy and safety of MDMA-AP is limited. The treating psychiatrist should also discuss the probability of treatment effectiveness and adverse events based on the clinical trial results. Patients should be advised that the MDMA- containing product has not been assessed by the TGA for quality, safety, or efficacy, and is not listed on the Australian Register of Therapeutic Goods (ARTG). Potential patients should be provided with comprehensive information about 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.

Good Practice Statement 4

Prior to initiating MDMA-AP, the treating psychiatrist should obtain written informed consent from potential patients. This consent should address likely benefits and harms of treatment (including potential serious adverse events); potential physical, psychological, and financial risks (including out-of-pocket costs of treatment); and what to expect before, during, and after treatment. Informed consent documentation should also include considerations specific to psychedelic therapies, such as potential media attention, social stigma, and confidentiality challenges that may differ from conventional psychiatric treatments. The psychiatrist is responsible for ensuring that any actual or potential conflicts of interest related to their association with companies that manufacture, market, or promote MDMA are declared to the patient. An opinion from a second psychiatrist may be obtained if there is a financial conflict of interest for the treating psychiatrist. Obtaining informed consent should be treated as an ongoing process, with regular review and adaptation based on the patient’s evolving needs and experiences. The consent should be documented in appropriate records.

Good Practice Statement 5

Patients should be encouraged, or otherwise given the option to involve a support person (such as a next of kin, family member, carer, or advocate) before and after treatment, including during the process of obtaining informed consent. Upon consent by the patient, the support person should be provided with information about what to expect before, during, and after treatment.

Good Practice Statement 6

Prior to initiating MDMA-AP, the psychiatrist and other clinicians involved in treatment delivery should explore patient preferences around supportive touch. Evidence is lacking about the value of supportive touch during MDMA-AP. There are important ethical and clinical considerations related to supportive touch. MDMA may heighten suggestibility, increase the perceived pleasantness of touch, and impair a patient’s capacity to provide or withdraw consent during dosing sessions. It is likely that people living with PTSD have variable values and preferences in relation to supportive touch. The default approach should be no supportive touch unless the patient explicitly opts in. If the patient opts in, clear boundaries, guided by patient preference, should be established during the informed consent process. This should be followed by a dynamic and ongoing consent process at each treatment phase (preparation, dosing, and integration). In situations where supportive touch is offered, therapists must have received appropriate training in its ethical and therapeutic application.

Good Practice Statement 7

Clinicians should assess and accommodate individual differences that may influence the experience and outcomes of therapy. This includes sensory sensitivities, communication preferences, executive functioning needs, cultural identity, and co-occurring health conditions. Particular consideration should be given to Autistic and ADHD individuals, who may have higher rates of trauma exposure and distinct sensory and cognitive profiles. Current evidence of benefits and harms may not be directly extrapolated to Autistic and ADHD individuals.

Implementation considerations when providing MDMA-AP

Good Practice Statement 8

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) and establish clear expectations for the broader care team in advance. Best practice involves inviting the general practitioner to be involved in the shared care. 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.

Good Practice Statement 9

All clinicians involved in the delivery of MDMA-AP should develop a strong therapeutic alliance with patients prior to and throughout MDMA-AP for building trust, ensuring emotional safety, and supporting the effectiveness of therapy.

Good Practice Statement 10

Safeguarding measures should be implemented during MDMA-AP sessions, including ensuring that only authorised personnel are present during dosing sessions, video-recording sessions where appropriate for accountability, and having two trained therapists who have only a professional (i.e. not a personal) relationship in the room during dosing sessions. The presence of two therapists who do not have a personal association is recommended as a risk mitigation strategy to provide a safeguard for both patients and therapists in the event of any concerns or allegations of misconduct. Safeguarding protocols should be documented and regularly audited, with particular attention to secure storage of session recordings and establishment of independent oversight mechanisms.

Good Practice Statement 11

Clinics delivering MDMA-AP should ensure the presence of appropriately trained personnel, such as medical doctors, to oversee medical or pharmacological interventions in managing adverse events. Appropriate clinical support and emergency management procedures should be rapidly available in case of medical emergencies, such as:

• Equipment and appropriately trained staff on-site to provide comprehensive clinical care, monitoring, and emergency resuscitation;
• An authorised Prescriber available to treat any complications that arise;
• Readiness to address treatment emergent adverse events and rescue medications available on-site;
• Close monitoring of patients during medication administration by appropriately trained staff; and
• Access to an accredited healthcare facility for the treatment of potential episodes of acute deterioration.

Good Practice Statement 12

Clinicians should advise patients that MDMA may impair the ability to drive or operate heavy machinery. Patients should be informed of, and comply with, relevant State legislation regarding not driving under the influence of MDMA and the potential for a positive amphetamine result on a roadside drug test.

Good Practice Statement 13

Treatment should be discontinued if a patient develops any conditions that contraindicate the use of MDMA (e.g., psychotic symptoms, significant physical health concerns). Decisions regarding discontinuation should be guided by comprehensive risk assessment, clinical judgement, and patient’s and carer’s preference.

Implementation considerations for post-treatment care

Good Practice Statement 14

Patients should only leave the treatment clinic once the acute effects of MDMA have fully worn off. This involves clinically assessing vital signs, level of awareness, mental stability, and ensuring a prearranged support person is available to accompany the patient home.

Good Practice Statement 15

Clinicians should set clear expectations about post-treatment care at the outset of treatment, including the possibility of continuing care with the therapist from MDMA-AP if a strong therapeutic alliance has been established. Clinicians providing MDMA-AP should facilitate the patient’s transition back to routine care after MDMA-AP treatment, including developing a comprehensive communication plan.

Good Practice Statement 16

Clinicians should discuss potential post-treatment care models (such as peer support groups, group integration sessions, or regular check-ins with clinicians) and communicate a clear process of follow-up or referral in order to provide patients with ongoing support after completing MDMA-AP. Clinicians should consider the model of post-treatment care for individuals living in rural and remote areas, including the role of primary health care professionals in ongoing management.

Implementation considerations for education and training

Good Practice Statement 17

The evidence in relation to MDMA-AP is rapidly evolving and there is potential value in a living evidence approach to future guideline development. Clinicians and people living with PTSD should make themselves familiar with the current best available research about possible benefits and harms as the basis for treatment decision-making.

Good Practice Statement 18

The Guideline Development Group concurs with the Royal Australian and New Zealand College of Psychiatrists (RANZCP) that the clinicians involved in the delivery of MDMA-AP should be registered with the Australian Health Practitioner Regulation Agency (AHPRA) or their equivalent governing body and operate within their recognised scope of practice. One of the therapists in the psychotherapy sessions should be a clinical psychologist or registered psychiatrist.

Good Practice Statement 19

Clinicians involved in the delivery of MDMA-AP should complete specific training. Psychiatrists should follow the Psychedelic Training Framework for Psychiatrists developed by the RANZCP. There is a need for formal and independent regulation or credentialing of training programs for psychiatrists and other clinicians to ensure consistent quality and standards for the delivery of MDMA-AP.

Good Practice Statement 20

Training should be available for the broader healthcare workforce to increase awareness and understanding of MDMA-AP, provide relevant and evidence-based information, and support making appropriate referrals. People with lived experience of PTSD emphasise the importance of clinician awareness, particularly among primary healthcare professionals who have an important role in providing evidence-based information for people living with PTSD.

Good Practice Statement 21

Patient information about MDMA-AP should be provided in a format that is accessible to the patient. Information may need to be tailored for different target populations such as culturally and linguistically diverse (CALD) communities, Aboriginal and Torres Strait Islander peoples, and emergency service workers. With permission, this information should also be made available to the patient’s support person.

Additional resources

This Guideline is intended to complement existing guidance on PTSD and psychedelic-assisted therapies. It should be read in conjunction with other relevant guidelines, memorandums, and guidance documents, including but not limited to:

• Australian Guidelines for the Treatment of Acute Stress Disorder, Posttraumatic Stress Disorder, and Complex PTSD; Phoenix Australia; 2020
• Clinical Memorandum: Therapeutic use of MDMA for PTSD and psilocybin for treatment resistant depression; Royal Australian and New Zealand College of Psychiatrists; 2023 
• Psychologists and psychedelic-assisted therapy: Position Statement; Australian Psychological Society; 2023 
• Authorised Prescriber Scheme: Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors; Therapeutic Goods Administration; 2024