Today, the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) announced the publication of the long-term follow-up results of six Phase 2 clinical trials of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) in the peer-reviewed journal Psychopharmacology. The paper is the most comprehensive analysis yet published of the safety and durability of treatment outcomes following MDMA-assisted psychotherapy for PTSD.
The results show that for a majority of participants, the benefits of MDMA-assisted psychotherapy for PTSD extended at least 12 months after the treatment sessions. Sponsored by MAPS, the controlled, randomized, double-blind trials found that, two months following their last session, 56% of 100 participants no longer met diagnostic criteria for PTSD. In the newly published analysis, 91 participants were interviewed at least 12 months later. Of these participants, 67% did not qualify for a PTSD diagnosis. One of the studies included data from an average of 3.8 years after treatment.
“Trauma exposure has emerged as one of the most pressing public health issues of our time and is now at the forefront of global consciousness due to the COVID-19 pandemic and rising visibility of systemic oppression,” said Berra Yazar-Klosinski, Ph.D., paper co-author and Deputy Director and Head of Research Development and Regulatory Affairs at MAPS. “Although our Phase 3 trials are not yet completed, these long-term data support the hypothesis that MDMA-assisted psychotherapy may provide significant advantages in treatment outcomes, safety, and durability over available PTSD treatments. This is the breakthrough that the world needs right now.”
The trials were conducted by independent investigators in South Carolina (two trials), Colorado, Canada, Switzerland, and Israel. Trial participants included women and men with chronic, treatment-resistant PTSD from a wide variety of causes.
PTSD symptoms were assessed using the Clinician-Administered PTSD Scale (CAPS-IV) at baseline, one to two months after their last MDMA-assisted psychotherapy session, and at least 12 months after their final session. The course of double-blind treatment included one to three eight-hour MDMA-assisted psychotherapy sessions spaced three to five weeks apart, combined with weekly non-drug psychotherapy sessions. Outcomes were assessed by blinded Independent Raters.
Based on these results, in August 2017, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD, acknowledging that it “may demonstrate substantial improvement over existing therapies” and agreeing to expedite its development and review. The FDA also considered MAPS’ prior published Phase 2 results when it agreed to MAPS’ Expanded Access program in January 2020. The research also received major confirmation when it passed its crucial interim analysis in May 2020.
The follow-up study found that long-term adverse events were minimal although the benefits were sustained. The most common harm reported at the long-term follow-up was worsened mood, reported by less than 4% of study participants. Further assessment of the long-term benefits and risks of MDMA-assisted psychotherapy is needed in future trials that include control groups.
The Psychopharmacology article was authored by Lisa Jerome, Ph.D., Allison Feduccia, Ph.D., Julie B. Wang, M.P.H., Ph.D., Scott Hamilton, Ph.D., Berra Yazar-Klosinski, Ph.D., Amy Emerson, B.A., Michael C. Mithoefer, M.D., and Rick Doblin, Ph.D.
"These long-term follow-up findings show that once people with PTSD learn that they can productively process traumatic memories instead of suppressing them, they can continue to heal themselves even after they have stopped receiving MDMA-assisted psychotherapy,” said co-author Rick Doblin, Ph.D., MAPS Founder and Executive Director.
MAPS is continuing its Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD at 15 sites in the U.S., Canada, and Israel. The Phase 3 trials are expected to be completed in late 2021, with FDA approval possible as early as mid-2022. MAPS is also in the process of obtaining regulatory approvals for Phase 2 trials in the Czech Republic, Netherlands, Germany, United Kingdom, Portugal, Norway, and Finland.
PTSD is a chronic mental health condition affecting 3-4% of the global population. PTSD can be caused by sexual assault, violent crime, military or law enforcement service, serious illness, and a wide variety of other causes. A new approach to treating PTSD is urgently needed, especially for those who do not respond to existing treatments.
To complete this research and make MDMA a legal medicine, MAPS, in collaboration with the Psychedelic Science Funders Collaborative (PSFC), has launched the $30 million Capstone Campaign. The Capstone Campaign has already secured the first $10 million in donations, and has brought together a diverse array of supporters committed to healing PTSD globally.
About MDMA-Assisted Psychotherapy for PTSD
MDMA-assisted psychotherapy uses MDMA to improve the effectiveness of psychotherapy for PTSD. The treatment involves up to three administrations of MDMA (75-125 mg) in conjunction with psychotherapy in a controlled clinical setting as part of a course of psychotherapy. Once approved, patients will not be able to take the MDMA home—patients won’t be filling their prescriptions at their local pharmacy. Instead, MDMA-assisted psychotherapy treatment will only be available through a doctor and only in supervised therapeutic settings from certified clinicians.
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $80 million for psychedelic therapy and medical marijuana research and education. For more information, visit maps.org.
MAPS-sponsored clinical trials are conducted by the MAPS Public Benefit Corporation (MAPS PBC), a wholly owned subsidiary of MAPS formed in 2014 for the special purpose of balancing social benefits with income from legal sales of MDMA, other psychedelics, and marijuana. For more information, visit mapspublicbenefit.com.
Links and Resources
- Long-term follow-up results published in Psychopharmacology (open access)
- Combined analysis of Phase 2 clinical trials (May 2019)
- Lay audience summary from Psychedelic.Support