June 25, 2020

MDMA-assisted therapy for PTSD edges closer

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Phase 3 clinical trials of MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) are currently underway in the USA, Canada, and Israel.1

These trials, spearheaded by the Multidisciplinary Association for Psychedelic Studies (MAPS), are the last step in determining if this treatment is safe and effective enough to merit the legal prescription of MDMA to enhance psychotherapy in the treatment of PTSD.

Pending a positive outcome from the trials, this could happen in the USA as soon as 2022.

Additionally, the American Food and Drug Administration (FDA) has given the green light to an expanded access program for people with treatment-resistant PTSD who do not meet the criteria to participate in the trials.2 This will provide compassionate access to 50 patients at multiple sites across the USA. 

Recently published follow up research with participants from phase 2 trials suggests early evidence that the assisted psychotherapy treatment can result in sustained improvements in PTSD symptoms.3

At least one year later, 67% of participants surveyed no longer met the criteria for a PTSD diagnosis.3

In light of the progression of MAPS-driven trials into phase 3 overseas, it’s worth taking a look at MDMA-assisted psychotherapy, and why it seems to help people with PTSD. 

MDMA research in Australia

While there is currently no research into MDMA-assisted psychotherapy for PTSD being conducted in Australia, there has been past interest. 

An application to conduct a trial in Australia in 2012, by MAPS in partnership with the Australian non-profit Psychedelic Research in Science and Medicine (PRISM), was rejected.4

It is critical to note that the MDMA itself is not the treatment, and no research is suggesting that it alone can ‘cure’ PTSD. Rather, MDMA appears to assist the process of psychotherapy.5, 6

MDMA and PTSD

MDMA – or 3,4-methylenedioxymethamphetamine – is a psychoactive substance classified as an empathogen. It is not the same as ecstasy.

Originally manufactured in the early 1900s to help control bleeding, MDMA became more commonly used in the 1970s and early 1980s by some psychiatrists to assist in the treatment of PTSD7 - a disorder that develops in some people who experience a traumatic event that makes them fear for their life or safety, or for those around them.

There are an estimated 1.4 million Australians suffering from PTSD.8

Symptoms can include ongoing experiences of flashbacks or distressing reminders of the event; dreams or nightmares about the event and difficulty sleeping; feelings of anger, guilt or shame; and, increased use of alcohol and other drugs.

Read more about PTSD.

How does MDMA assist with psychotherapy?

MDMA might be able to assist psychotherapy because it decreases defensiveness and anxiety, increases relaxation, and improves mood.5 It may also improve the bond between the therapist and the patient.5

What this means in practice is that a person may be more able to revisit the traumatic memories and work through the emotions attached to them without being re-traumatised or finding the associated anxiety or fear too overwhelming to continue the session.5

Because MDMA appears to reduce anxiety associated with recalling traumatic experiences, it can enable increased insight and memory.5

Negative memories may be perceived as less confronting, allowing the therapist and the patient to engage in productive therapeutic sessions, without the patient becoming hyper-aroused due to stress.

In combination with psychotherapy, the use of MDMA provides the capacity “to hold the traumatised patient in a state of emotional security, providing a state of empathic self-reflection in which, for the first time in their lives, they can be with their traumatic memories without being overwhelmed by the powerful negative affect that usually accompanies recall of their most frightening thoughts”.9

Current research

Research into the use of MDMA as a therapeutic agent ceased in the mid-1980s when the USA made the drug illegal, largely due to increased police seizures of the drug intended for use in recreational settings.10

Clinical research started to pick up again with a study published in 2010, and after successful phase 2 clinical trials demonstrated significant improvements in the symptoms of PTSD, it was designated a ‘breakthrough therapy’ by the FDA in 2017.11

Now in phase 3, clinical trials are being run as randomised, double-blind, placebo-controlled studies across 15 locations in the USA, two in Canada, and three in Israel.1 These trials are the final stage prior to the FDA deciding if it will approve MDMA to be prescribed for use alongside psychotherapy in the treatment of PTSD.

MAPS has released an infographic about its ongoing research. 

Learn more about the phases of clinical trials.

MDMA is not ecstasy

It is critical to note that clinical MDMA and ecstasy are not the same.

MDMA for clinical use is produced to a pharmaceutical standard. A regulated dose is administered in a controlled setting by trained health professionals for specific conditions only.

The dose and purity of ecstasy is unknown. 

Ecstasy may contain no, or a small amount of, MDMA and can be adulterated with other potentially dangerous ingredients. It is used in a non-clinical setting without the support of health professionals.

Media reporting and public or political fear around the toxicity or harms caused by ecstasy should not impact the willingness to explore a new clinical treatment for people who have a serious psychiatric condition. 

Similarly, clinical trials of MDMA-assisted psychotherapy cannot be confused with suggesting that MDMA alone will ‘cure’ PTSD, or that ecstasy is safe.

The use of a pharmaceutical-grade drug in a controlled, clinical setting should never be confused with the recreational use of a drug. To do so risks both holding back clinical research and spreading misinformation about the potential safety of recreationally using a drug.

Multidisciplinary Association for Psychedelic Studies (MAPS). A Phase 3 Program of MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder (PTSD): MAPS; [cited 18 Jun 2020]

PRESS RELEASE: FDA Agrees to Expanded Access Program for MDMA-Assisted Psychotherapy for PTSD [press release]. January 17 2020.

Jerome L, Feduccia AA, Wang JB, Hamilton S, Yazar-Klosinski B, Emerson A, et al. Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials. Psychopharmacology. 2020.

Multidisciplinary Association for Psychedelic Studies. Australia: Ethics Committee Confirms Rejection of Study Protocol Online: MAPS; 2012 [cited 18 Jun 2020]

Morgan L. MDMA-assisted psychotherapy for people diagnosed with treatment-resistant PTSD: what it is and what it isn't. Ann Gen Psychiatry. 2020;19:33-.

Barone W, Beck J, Mitsunaga-Whitten M, Perl P. Perceived Benefits of MDMA-Assisted Psychotherapy Beyond Symptom Reduction: Qualitative Follow-Up Study of a Clinical Trial for Individuals with Treatment-Resistant PTSD. Journal of Psychoactive Drugs. 2019;51(2):199-208.

Doblin R. A clinical plan for MDMA (ecstasy) in the treatment of posstraumatic stress disorder (PTSD): partnering with the FDA. Journal of Psychoactive Drugs. 2002;34:185-94.

Australian Bureau of Statistics. National Survey of Mental Health and Wellbeing: Summary of Results, 2007. 2007.

Sessa B. Why Psychiatry Needs 3,4-Methylenedioxymethamphetamine: A Child Psychiatrist's Perspective. Neurotherapeutics. 2017;14(3):741-9.

Sessa B, Higbed L, Nutt D. A Review of 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy. Frontiers in Psychiatry. 2019;10(138).

Mithoefer MC, Feduccia AA, Jerome L, Mithoefer A, Wagner M, Walsh Z, et al. MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology. 2019;236(9):2735-45.

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