We hope that you and your loved ones are taking good care and finding opportunities for connection and community. In the midst of such uncertainty, we wanted to extend our best wishes to each of you.
How the MAPS-sponsored MDMA-Assisted Therapy trials are responding to COVID-19
Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD are currently underway in the United States, Israel, and Canada. Participants enrolled in the trial will continue to receive care from their study therapists. Preparatory and integration sessions are now being conducted virtually. The MAPS Public Benefit Corporation (MAPS PBC) video deparment has moved quickly to implement new systems and new uses of existing systems to support the delivery of virtual therapy sessions and the continuity of clinical supervision and adherence rating programs.
Since MDMA-assisted psychotherapy sessions must take place in person, many experimental sessions have been postponed until further guidance from public health officials. Study therapists are maintaining regular phone contact with enrolled participants to ensure their safety and to provide support during this challenging time. Enrollment of new participants is on hold.
Planned MDMA-assisted psychotherapy for PTSD studies in the European Union are currently on hold according to guidance provided by the European Medicines Agency (EMA).
MAPS PBC is continuing to work diligently on protocol reviews, regulatory application materials, and follow-ups from previous clinical trials. With FDA granting the Expanded Access protocol in January 2020, preparations are continuing forward so that sites will be ready to initiate the study once public health status permits.
Clinical trials involving healthy volunteers are on hold to prevent participants, therapists, doctors, and other staff from being exposed to in-person contact.
Participant safety is our number one priority; digital technology provides a pathway to continue psychological support while decreasing exposure to COVID-19.
We wish everyone health, safety, and support. Our hope is that public health initiatives, the commitment and support of countless communities, and the hard work of courageous medical health professionals and researchers will bring us all to the other side of COVID-19 as safely and swiftly as possible.
MDMA Therapy Training Program
While MAPS PBC is not currently recruiting new sites and the MDMA Therapy Training Program is not actively enrolling new trainees, qualified and interested sites and therapists may still submit an application to be considered at a later date. Information about application requirements and instructions to apply and can be found on our webpage. The MAPS PBC Therapy Provider Connect Portal is a community discussion forum for therapy providers, physicians and facilities to connect with one another to develop a site or treatment staff, in order to become eligible to participate in a MAPS PBC MDMA/PTSD protocol.