- The FDA lifted the clinical hold from a MAPS-sponsored Phase 2 study of MDMA-assisted group therapy for the treatment of posttraumatic stress disorder among veterans at the VA Portland Health Care System
- This essential proof-of-principle study tests safety and logistics of group therapy, the first step in fully investigating the treatment for efficacy and broader patient access
- The data-driven negotiation strategy included substudies of participants’ no-overnight stay conducted in the first Phase 3 trial of MDMA-assisted therapy for PTSD
After months of negotiations with the U.S. Food and Drug Administration (FDA), the Multidisciplinary Association for Psychedelic Studies (MAPS) has been permitted to initiate the MAPS-sponsored Phase 2 Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder (PTSD) in Veterans (MPG1). Despite its status as the world’s leading research center for PTSD, few Veterans Affairs (VA) facilities have hosted clinical trials of MDMA-assisted therapies for PTSD.
Though the study was approved by the VA Portland Health Care System Institutional Review Board months earlier, the FDA placed a partial clinical hold due to a theoretical safety concern surrounding a perceived need for overnight stays at the trial location, a requirement that was not part of the proposed study protocol. In response to the clinical hold, MAPS submitted safety data from a Phase 3 sub-study; the FDA agreed to lift the clinical hold on June 15, 2022.
In the early Phase 2 studies, we included overnight stays as an opportunity for the participants to rest and integrate what unfolded during their MDMA-assisted therapy session. Though we had no data to suggest there was a concern about safety overnight, these stays became required from the FDA perspective. In the Phase 3 program, we’re collecting safety data from participants with and without overnight stays to gather evidence to whether overnight stays are necessary. From the data we have so far, that doesn’t seem to be the case. We are pleased that the safety data in the Phase 3 substudy without overnight stays could support the FDA in making the data driven decision to permit no overnight stays in this important group study research.
Allison Coker, Ph.D., Associate Director of Regulatory Affairs, MAPS PBC
The study is conducted by MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of MAPS, led by Chris Stauffer, M.D., and hosted within the VA Portland Health Care System. Eighteen Veterans in three cohorts of six will undergo the first of two MDMA-assisted therapy sessions individually and the second treatment session in their group cohort, along with individual and group preparation and integration sessions. If MAPS’ appeal was not granted, each cohort of six Veterans would have been obligated to stay overnight in the VA hospital after their MDMA-assisted therapy sessions.
There is so much yet to explore regarding the relational potential of MDMA-assisted therapy, and research on group therapy combined with MDMA sessions is a logical next step. What drives this work for me are the unique therapeutic properties of group cohesion that I’ve witnessed in my previous group therapy trials with oxytocin and psilocybin. If the FDA finds MDMA-assisted therapy to be safe and effective, the benefit of the group model for scalability and access could be an added bonus. My team and I are grateful that the FDA is permitting our innovative MDMA-assisted group therapy protocol, including sending Veterans home after MDMA sessions with a pre-screened and informed support person, to proceed.
Chris Stauffer, M.D., Principal Investigator for MPG1
The first Phase 3 trial of MDMA-assisted therapy for PTSD achieved encouraging results among participants with severe, chronic PTSD: two months after the final experimental session, 88% of participants experienced a ≥10 point reduction in PTSD symptoms and 67% no longer met the criteria for a diagnosis of PTSD. MDMA may be an effective catalyst for other therapy modalities commonly used in the treatment of PTSD. MAPS PBC is collaborating with experts in these modalities, trained through the MDMA Therapy Training program, to explore the potential of other treatments through proof-of-principle studies such as MPG1. Group therapy, which can be a highly effective treatment for people with common experiences, may also be highly effective at reducing costs for patients. If this trial indicates the treatment may be safe and effective, further research of group therapy will be pursued as one element of MAPS’ comprehensive patient access and health equity programs.
The safety and efficacy of MDMA-assisted therapy is currently under investigation. It has not yet been approved by the FDA or other regulatory authorities, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future regulatory approval or availability of MDMA-assisted therapy.
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. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since MAPS was founded, philanthropic donors and grantors have given more than $130 million for psychedelic and marijuana research and education. MAPS has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator.
ABOUT MAPS PUBLIC BENEFIT CORPORATION
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, commercialization, and patient access of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization. MAPS PBC is the parent company of MAPS EU, formed to organize and administer clinical trials of investigational MDMA-assisted therapy for PTSD in the United Kingdom and European Union.