Photo by Fakurian Arts on Unsplash
Photo by Fakurian Arts on Unsplash

EXPERT REACTION: Therapy on ecstasy could treat severe PTSD

Embargoed until: Publicly released:
Peer-reviewed: This work was reviewed and scrutinised by relevant independent experts.

Randomised controlled trial: Subjects are randomly assigned to a test group, which receives the treatment, or a control group, which commonly receives a placebo. In 'blind' trials, participants do not know which group they are in; in ‘double blind’ trials, the experimenters do not know either. Blinding trials helps removes bias.

People: This is a study based on research using people.

MDMA-assisted therapy is a safe and effective treatment for people with severe post-traumatic stress disorder (PTSD), according to an 18-week clinical trial of 90 long-term sufferers. They were given three doses of MDMA or placebo, paired with three sessions of talk therapy. The researchers saw a "significant and robust" reduction in symptoms, even in people with associated conditions that can make PTSD harder to treat - like childhood trauma, dissociation, and depression. The researchers say MDMA may return the brain to a state that is usually inaccessible after adolescence - allowing patients to process and release difficult fear-related memories.

Journal/conference: Nature Medicine

Link to research (DOI): 10.1038/s41591-021-01336-3

Organisation/s: University of California - San Francisco, US

Funder: This clinical trial was sponsored by MAPS, a 501(c)(3) non-profit organization. MAPS provided the MDMA and fully funded this study from private donations.

Media release

From: Springer Nature

MDMA-assisted therapy is safe and effective for the treatment of people with severe post-traumatic stress disorder (PTSD), according to a phase 3 clinical trial published in Nature Medicine. This study was granted an FDA Breakthrough Therapy designation and provides a new treatment option for people who suffer from PTSD.

Selective serotonin-reuptake inhibitors are the FDA-approved first-line therapeutics for the treatment of PTSD, but nearly half of patients do not respond to these drugs. The substituted amphetamine MDMA also targets the serotonin system and has shown promise in animal and early clinical studies as a treatment for PTSD.

Jennifer Mitchell and colleagues conducted a phase 3 randomized clinical trial during which MDMA was administered to 90 participants, in conjunction with manualized therapy, over the course of 18 weeks. The authors found that MDMA was well tolerated in patients with severe PTSD, and observed a significant and robust reduction in symptoms relative to those of patients receiving a placebo combined with a similar therapy. This treatment approach was also effective in patients with associated comorbidities, such as childhood trauma, dissociation and depression.

These results suggest that, compared with current first-line pharmacological and behavioral therapies, MDMA-assisted therapy has the potential to be a beneficial new treatment for patients with PTSD.

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Expert Reaction

These comments have been collated by the Science Media Centre to provide a variety of expert perspectives on this issue. Feel free to use these quotes in your stories. Views expressed are the personal opinions of the experts named. They do not represent the views of the SMC or any other organisation unless specifically stated.

Professor Paul Glue, Brain Health Research Centre, University of Otago

Post-Traumatic Stress Disorder (PTSD) is a type of anxiety disorder that’s triggered by a traumatic event, such as an assault, accident, or exposure to trauma. PTSD symptoms can include flashbacks to the traumatic event, hypervigilance and nightmares. Standard treatments for PTSD include medications and various psychotherapies, however up to 70 per cent of patients may not respond.

MAPS is the Multidisciplinary Association for Psychedelic Studies, a US-based organization that has sponsored development of MDMA (ecstasy) for PTSD.  Prior to publication of this new Phase 3 clinical trial, they had published six smaller Phase 2 studies, which consistently showed that MDMA-assisted psychotherapy was more effective in reducing symptoms of PTSD compared with placebo plus psychotherapy.  The recently published Phase 3 trial results are consistent with their earlier findings and confirm that the treatment is safe and well tolerated.

It is likely that US FDA will require an additional similar Phase 3 study before they would approve MDMA-assisted psychotherapy for treating PTSD.

The results are very encouraging as they indicate that there may be a new effective treatment for a severe disorder with high levels of treatment resistance and few alternative treatments. Because this treatment requires considerable psychotherapy input along with medication (i.e., this is not just dosing with medication), if this treatment were to become available in New Zealand, we lack large numbers of clinical psychologists and/or psychotherapists to allow wide access to treatment.

Last updated: 14 May 2021 12:09pm
Declared conflicts of interest:
MAPS (sponsor of this study) have agreed to supply a research team at Otago and Auckland unis with MDMA for a clinical trial (to treat depression/anxiety in patients with terminal cancer). I am part of that research team.
Associate Professor Suresh Muthukumaraswamy, School of Pharmacy, University of Auckland

This is the latest in a series of studies sponsored by the non-profit organisation MAPS to investigate the use of MDMA-assisted psychotherapy for patients with PTSD.

Around 67 per cent of patients were successfully treated with this approach compared to 32 per cent of patients who received therapy alone. This is a really high response rate in patients who are very unwell.

It is critically important to recognize that MDMA is given under clinical supervision as an aid to a psychotherapy – each patient gets around 12 hours of therapy and the drug, which is of pharmaceutical grade quality and is never given without therapy and preparation sessions.

The study was completed under US FDA breakthrough status and MAPS hopes that the MDMA-assisted therapy approach will be approved in 2023 by the FDA.

If that timeline goes as planned, we may see an application for the introduction of MDMA-assisted therapy for PTSD in New Zealand in the years after that.

Last updated: 14 May 2021 12:06pm
Declared conflicts of interest:
No conflict of interest.

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