U.S. researchers have found that MDMA-assisted therapy significantly reduced symptoms of severe PTSD in patients.
Ninety people with severe PTSD were randomly assigned to have therapy sessions either with MDMA or placebo. The group that took MDMA under clinical supervision had a greater reduction in symptoms over the course of 18 weeks. The researchers also found the experimental treatment was “safe and well-tolerated.”
The study is available here.
The SMC asked experts to comment on the research.
Professor Paul Glue, University of Otago, comments:
“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.”
Conflict of interest statement: “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, comments:
“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.”
No conflict of interest.