October 21, 2021

MDMA-assisted therapy for PTSD edges closer

MDMA-therapy.jpg

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, led by the Multidisciplinary Association for Psychedelic Studies (MAPS), are the last step in figuring out if this treatment is safe and effective enough for MDMA to be legally prescribed to treat PTSD.

If there’s a positive result from the trials, this could happen in the USA as soon as 2022.

The American Food and Drug Administration (FDA) has also been given the green light to an expanded access program for a small number of people with treatment-resistant PTSD who do not meet the criteria to participate in the trials to have access to the treatment.2

Follow-up research from the Phase 2 trials showed MDMA-assisted treatment was effective in improving PTSD symptoms.3 At least one year later, 67% of Phase 2 trial participants surveyed no longer met the criteria for a PTSD diagnosis.3

With the progress 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.

Learn more about the phases of clinical trials.

MDMA research in Australia

While there’s currently no research into MDMA-assisted psychotherapy for PTSD in Australia, there has been past interest. An application to run 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’s important to note that the MDMA itself is not the treatment, and research does not suggest it’s a ‘cure’ for PTSD. What MDMA seems to do is help the process of psychotherapy.5, 6

MDMA and PTSD

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

It was first manufactured in the early 1900s to help control bleeding. It became more commonly used in the 1970s and early 1980s by some psychiatrists to help in the treatment of PTSD.7

PTSD affects an estimated 1.4 million Australians.8 People can develop PTSD after experiencing a traumatic event, making them fear for their life or safety, or for those around them.

Symptoms can include:

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

Read more about PTSD.

MDMA isn’t ecstasy

Clinical MDMA and ecstasy are not the same.

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

In contrast, the dose and purity of ecstasy is unknown.

Ecstasy may contain no, or a small amount of, MDMA and can be mixed with other potentially dangerous ingredients.

Media reporting and public or political fear around ecstasy’s toxicity or harm shouldn’t influence the new clinical treatments being explored for people who have a serious psychiatric condition.

Similarly, clinical trials of MDMA-assisted psychotherapy shouldn’t be mixed up with suggestions that MDMA alone will ‘cure’ PTSD, or that ecstasy is safe.

A pharmaceutical-grade drug used in a controlled, clinical setting should not be confused with the recreational use of a drug. Doing so risks both holding back clinical research and spreading misinformation about the potential safety of using a drug recreationally.

How does MDMA assist with psychotherapy?

MDMA can assist psychotherapy by reducing defensiveness and anxiety, increasing relaxation and improving mood.5 It can also improve the bond between the therapist and patient.5

In practice a person may be able to revisit traumatic memories and work through their emotions 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 help increase insight and memory.5

Negative memories may feel less confronting, allowing the therapist and patient to have productive therapeutic sessions without the patient becoming overly anxious due to stress.

Combined with psychotherapy MDMA can “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 stopped in the mid-1980s when the USA made the drug illegal, mainly because of increased recreational use.10

Clinical research picked up again with a study published in 2010, and after successful Phase 2 clinical trials showed huge improvements in the symptoms of PTSD. The FDA  called MDMA a ‘breakthrough therapy’  in 2017.11

Now in Phase 3, clinical trials are being run as randomised, double-blind, controlled studies across 15 locations in the USA, two in Canada, and three in Israel.1

These trials are the final stage before the FDA decides if it will approve MDMA to be prescribed for use alongside psychotherapy as a way of treating PTSD.

MAPS has released an infographic about its ongoing research.

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.

Related news


Share this