Expanded Access Training Update: May 2019

The MDMA Therapy Training Program has launched a series of trainings to prepare therapy providers to become eligible to work on a MAPS-sponsored MDMA/PTSD protocol. On May 4-11, 2019, 53 therapists, doctors, and counselors gathered at Shambhala Mountain Center in Red Feather Lakes, Colorado, to receive training from Marcela Ot’alora M.A., L.P.C., and Bruce Poulter, R.N., on MDMA-assisted psychotherapy for PTSD in a six-and-a-half-day training retreat. Trainees represented more than 20 potential MDMA/PTSD research sites across 13 states. International guests hailed from Israel and Canada.

Applications remain open for the MDMA Therapy Training for Communities of Color event, taking place August 10-17, 2019 in Louisville, Kentucky, led by Marcela Ot’alora, M.A., L.P.C., and Monnica Williams, Ph.D., A.B.P.P., with support from additional trainers. More details about this event, including exact location, schedule, scholarship and registration fees, and line-up of guest presenters for the Psychedelic Medicine and Cultural Trauma Community Workshop August 10-11, will be available as they are updated on our event page. Scholarships will be available for therapy providers and community organizers of color through the generous contributions of Open Society Foundation, RiverStyx Foundation, and several other pledges that are in the works. Details on scholarship will be posted online as soon as they are available.

We are pleased to announce that an additional training retreat has been scheduled for September 29 – October 6, 2019 in Asheville, North Carolina. The training will be led by Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D. Eligible therapy providers interested in this event can submit the MDMA Therapy Training Application, and respond yes to the question about interest in this event. For those who have already completed applications, you will be automatically considered for this fall event and do not need to re-apply. Additional training retreats will be announced via the training newsletter as they are scheduled.

In January 2019, MAPS PBC submitted an MDMA-assisted psychotherapy for PTSD protocol to the U.S. Food and Drug Administration (FDA) as part of an application to participate in the FDA Expanded Access program. MAPS PBC is currently negotiating with FDA to gain clearance for the protocol. On May 16, 2019, FDA sent MAPS some comments on our proposed Expanded Access protocol. MAPS will respond in the next week or so, with a reply from FDA anticipated in early July 2019. The Expanded Access program’s purpose is to grant access to potentially beneficial investigational treatments for individuals or populations facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available. If approved, Expanded Access would allow additional qualified sites to provide MDMA-assisted psychotherapy for participants with treatment-resistant PTSD under a MAPS protocol.

Sites in the U.S. and U.S. Territories interested in being considered to participate in an MDMA PTSD Expanded Access protocol, pending approval, may now apply with MAPS PBC to assess eligibility and obtain the prerequisite training to administer MDMA-assisted psychotherapy. The basic requirements of a qualified site are 1) Treatment Facility conducive to MDMA-assisted psychotherapy, 2) therapy team, qualified and able to complete MDMA Therapy Training Program, and 3) prescribing physician who can obtain a DEA Schedule 1 license for MDMA.

Site and practitioner application procedures are posted on our webpage. Each site must submit one site questionnaire. Additionally, each therapy provider must submit an MDMA Therapy Training Application for Therapy Providers. Only applicants affiliated with a qualifying site can be considered for training at this time. MAPS PBC will review applications on an ongoing basis, as they are received.

The MDMA Therapy Training Program takes seriously our obligation to participant safety and to reflecting internally to promote ethical growth and awareness surrounding diversity and inclusion. In service to this commitment, the MDMA Therapy Training Program presented the newly published MAPS MDMA-Assisted Therapy Code of Ethics to its trainees, and is implementing procedures to have therapy providers adhere to these ethical guidelines. The Code of Ethics can be found in the Spring 2019 edition of the MAPS Bulletin, Women and Psychedelics. MAPS has just posted a statement: Public Announcement of Ethical Violation by Former MAPS-Sponsored Investigators.

Additionally, trainees in the May cohort participated in a workshop on Power, Privilege, and Diversity led by Dr. Gaia Mika.

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