Happy Winter from MAPS Public Benefit Corporation (MAPS PBC)!
We are delighted to send you this update on the status of the MDMA Therapy Training Program, and updates about upcoming opportunities through the anticipated US FDA Expanded Access Program.
The Multidisciplinary Association for Psychedelic Studies (MAPS) recently received a grant from Open Society Foundation (OSF) to support an MDMA Therapy Training event for Communities of Color in August 2019 led by Marcela Ot’alora G, LPC, and Monnica Williams, PhD, with support from additional trainers. The purpose of this training is to ensure that MDMA therapy will be available to communities of color by training therapy providers of color in this modality, to expand thinking about PTSD to include racial trauma, and to inform the ongoing development of culturally-informed curriculum within the MDMA Therapy Training Program. In addition to the training’s focus on MDMA-assisted psychotherapy, community leaders will join trainees for a workshop entitled Psychedelic Medicine and Cultural Trauma, to engage in dialogue about the social, political, cultural and historical causes of trauma, as well as to discuss barriers to acceptance of MDMA-assisted psychotherapy in communities of color while envisioning ways forward. MAPS will continue to fundraise for this specific event, and to provide training opportunities for therapy providers who come from or work with marginalized communities. More information on this event, including date, time and application information will be posted online in the coming weeks. If you would like to support MDMA Therapy Training opportunities for people of color, please consider making a donation.
From September 26 to October 3, 2018, Annie Mithoefer, BSN, and Michael Mithoefer, MD, led a weeklong in-person training in the Netherlands focused on MDMA-assisted psychotherapy for the treatment of Posttraumatic Stress Disorder (PTSD). Sixty therapists and researchers attended the training, representing fourteen countries. Many of these trainees will provide MDMA-assisted psychotherapy to participants with PTSD under a MAPS protocol at several European sites, starting in 2019.
In January 2019, the MDMA Therapy Training Program will host a training event in Israel to prepare Israeli therapists to work on an Open Access protocol. Over the next year or two, as Phase 2 and 3 trials in Europe progress and additional protocols are developed and approved internationally, the MDMA Therapy Training Program will offer more training opportunities for international providers.
As Phase 3 clinical trials begin in the United States, Israel, and Canada, 82 therapy providers are now completing their final stage of training in clinical supervision, which will continue to be an integral part of the MDMA Therapy Training Program. The results of the Phase 3 studies will support a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), to make MDMA-assisted psychotherapy into a legal prescription medicine, anticipated to take place in 2021. Participant screening and enrollment for Phase 3 has officially opened. If you know someone with PTSD interested in participating in a clinical trial, they can visit clinicaltrials.gov and search “PTSD MDMA”, then click on the sites that are recruiting to find more information to apply.
As a Public Benefit Corporation, MAPS PBC is obligated to balance profit and public benefit and commit to social responsibility, transparency, and legal accountability. The team at MAPS PBC is currently engaging in a multilevel review of the subject of ethics, including developing an ethics scorecard to assess MAPS PBC on ethical commitments related to respect for persons, radical transparency, justice and fairness, and democratic deliberation.
Given the special ethical considerations of MDMA-assisted psychotherapy, as a psychedelic organization, we take seriously our commitment to safety. The MDMA Therapy Training Program is currently drafting a Code of Ethics for MDMA therapy providers, focusing on the professional guidelines for ethical therapeutic relationship. We are committed to reflecting internally on ethical care, to incorporating ethics as a foundation for our training curriculum, and collaborating with a growing network of psychedelic psychotherapy providers. When the Code of Ethics is finalized, it will be published online.
Expanded Access Updates
Currently, the MDMA Therapy Training Program is preparing for the launch of a series of Expanded Access training events in the US next year. In the coming weeks, MAPS will apply for a special US FDA program called Expanded Access (EA), which allows the use of an investigational treatment outside of a clinical trial. The 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. You can learn more about Expanded Access on the FDA's website.
If approved, Expanded Access for MDMA-assisted psychotherapy for PTSD would allow additional qualified sites in the US to provide this treatment to eligible patients under a MAPS treatment protocol. The basic requirements of a qualified site are: 1) facility conducive to this treatment, 2) qualified and trained therapy team, 3) Medical Doctor who can obtain a DEA Schedule 1 license for MDMA. Sites must also gain Drug Enforcement Administration (DEA) approval to manage, store, and administer MDMA, a controlled substance. As MAPS gets closer to application, the requirements will be better understood. Since Expanded Access is a US FDA program, only sites in the US and US territories may participate. International programs may become available in the future.
An online application for sites in the US and US territories that are interested in the MDMA PTSD Expanded Access protocol will be published early in the new year at maps.org. The MPBC Training and Supervision Department will review applications on an ongoing basis. The training department is developing a platform for therapists and sites to connect online in the interest of establishing clinics for Expanded Access.
If you haven’t already, please read the MDMA-Assisted Psychotherapy for PTSD Treatment Manual and Investigator's Brochure, which outline the structure of therapy sessions, from practical considerations to therapeutic orientation. Applicants should be familiar and comfortable with the protocol before submitting an application.
We encourage each site, in choosing location and therapy teams, to consider diversity, inclusivity, and cultural and racial competence. One of the most robust ways to provide accessible care is to train therapists and practitioners from diverse backgrounds, including people of color and the LGBTQIA+ community. If you are a therapist from a marginalized community, we encourage you to reach out to us at firstname.lastname@example.org.
We look forward to sharing further updates as we learn more. In the meantime, you may find some of the resources and trainings listed below helpful. We will continue to send related resources and articles, as well as updates on training and Expanded Access when pertinent information is available. Thank you for your patience, and for your dedication to this work!
We wish you an inspiring and rejuvenating Winter Season and transition into 2019!
From the MDMA Therapy Training Program!
"We speak more ethically and act more ethically when we begin to see and honor the web-like context of relationship that weaves among the many facets of both caregiver and client. We naturally make more ethical decisions when we honor the intricate connections extending beyond the walls of the therapy session into family, culture, ecosystem, and even into unseen dimensions.”
- Kylea Taylor, from “The Ethics of Caring: Honoring the Web of Life in Our Professional Healing Relationships”
Upcoming Events and Trainings
Integrating Psychedelic Experiences
With Julie D. Megler, MSN, NP-BC and Mary McDermott, MFT, LPCC, CYT
Jan 12, 2018
CIIS, San Francisco, CA
From Trauma to Dharma Training, Level 1 and 2
With Manuela Mischke-Reeds, MA, MFT and Shai Lavie, MA, MFT
Various dates beginning Jan 2019
Online and in Berkeley, CA
Somatic Experiencing Trauma Trainings
Inner Ethics™: Finding the Power and Beauty of Right Relationship and Spiritual Emergency: Embracing Unexpected Transformation
With Kylea Taylor and Diane Haug
Jan 29 - Feb 3 2019, Joshua Tree, CA
Psychedelics 101 & 102 for Clinicians
Feb 9 - 10, 2019
Psychedelic Harm Reduction and Integration Consultation Group
Feb 14 - May 2, 2019
With Ingmar Gorman, PhD, and Elizabeth Nielson, PhD, CASAC
The Center for Optimal Living, New York, NY
Arizona Psychedelics Conference
Feb 8 - 10, 2019
Recommended Resources and Readings
Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study
By Alicia L. Danforth and additional authors
In the Journal of Psychopharmacology, published Sept 2018
The Dissociative Subtype of PTSD: An Update of the Literature
By Schiavone, Frewen, McKinnon, and Lanius, in PTSD Research Quarterly
MAPS Psychedelic Science Webinar Series
View past recordings
Flip the Clinic - A visual commitment to put love first, drives healthcare-wide culture shift
Sensorimotor Psychotherapy: One Method for Processing Traumatic Memory
By Pat Ogden, Ph Dand Kekuni Minton, PhD
Cultivating Inner Growth: The Inner Healing Intelligence in MDMA-Assisted Psychotherapy
By Shannon Clare Carlin, M.A.
MAPS Bulletin Winter 2018: Vol. 28, No. 3
United to Cure Planetary PTSD: Advancing the Movement in 2019
By Paula Graciela Kahn
MAPS Bulletin Winter 2018: Vol. 28, No. 3
Healing Justice: A Podcast for Stories and Practices at the Intersection of Collective Healing and Social Change
Please visit the MAPS Newsletter for other events and articles related to psychedelic research and education.