MDMA Therapy Training Program Newsletter, Spring 2019
Happy Spring 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 information about upcoming training opportunities.
The MDMA Therapy Training Program is accepting applications for new training cohorts to provide therapy providers with the opportunity to complete the required training to become eligible to work on a MAPS MDMA PTSD protocol. The MDMA Therapy Training Program has launched a series of trainings to prepare therapy providers to become eligible to work on a MAPS MDMA PTSD protocol. As part of this series, on March 3 - 10, 2019 fifty-three therapists, doctors and counselors gathered in Asheville, North Carolina to receive training from Annie Mithoefer, BSN, and Michael Mithoefer, MD, on MDMA-assisted psychotherapy for PTSD in a six-and-a-half-day training retreat. Trainees represented more than 16 potential MDMA PTSD sites across 13 states. Additional guests in attendance received training to prepare for Phase 3 protocols in Europe and Canada, for a pilot MAPS-sponsored study of MDMA in the treatment of Eating Disorders (please see donation link if you or someone you know is interested in supporting this study), and for an investigator-sponsored trial integrating Cognitive Processing Therapy with MDMA as a treatment for PTSD.
In January 2019, MAPS PBC submitted an MDMA-Assisted Psychotherapy for PTSD protocol to the US Food and Drug Administration (FDA) as part of an application to participate in the FDA Expanded Access (EA) program, which allows for 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.
If approved, Expanded Access for MDMA-assisted psychotherapy for PTSD would allow additional sites to meet the requirements to provide this treatment to eligible patients under a MAPS protocol. Only sites in the US and US territories may participate in a US FDA Expanded Access program. Over the coming years, as Phase 2 and 3 trials in Europe progress and additional protocols are developed and approved internationally, the MDMA Therapy Training Program plans to offer more training opportunities internationally. Each country has a unique set of regulations; many regions have programs similar to Expanded Access, sometimes called “Compassionate Use.”
To support the development of Compassionate Use internationally, on January 27 – February 1, 2019, the MDMA Therapy Training Program trained 47 practitioners in Israel. This training event prepared therapy providers to work on a Compassionate Use protocol in Israel, with approval and funding by the Israeli Ministry of Health to treat 50 participants. Additional Israeli and Palestinian attendees received training to prepare for a pilot study researching the potential of psychedelic-assisted reconciliation in a group process centering intergenerational trauma. The event was hosted by the community of Neve Shalom/Wahat al-Salam, “Oasis of Peace,” an intentional village co-founded by Israelis and Palestinians. The training was led by Annie Mithoefer, BSN, and Michael Mithoefer, MD, and Israel Phase 3 Clinical Investigators Keren Tzarfaty PhD, MFT, and Ido Siemion, PhD.
Trainees at Neve Shalom/Wahat al-Salam
Qualified sites in the US and US 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 for PTSD under a MAPS protocol. 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 at maps.org/training. There are two layers of application: 1) Site Questionnaire, and 2) MDMA Therapy Training Application for Therapy Providers. 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.
If you have already submitted an application for your site and therapy teams, thank you! The training team will be in touch with you.
While we look forward to enrolling more training cohorts, we are also working within research timelines to support the development of a new protocol that will ensure that all trainees have an opportunity to engage with experiential learning. The MDMA-assisted Psychotherapy for Healthy Volunteers Therapist Training protocol, referred to as “MT2,” resembles a brief version of the MDMA-assisted psychotherapy protocol outlined for the treatment of PTSD. The MT2 protocol includes a screening process, one 90-minute Preparatory Session, one 8-hour MDMA Session, one 90-minute Integration Session, and a follow-up period. This protocol was submitted to the FDA last week and is currently under review. To satisfy the Part C Experiential Learning component, each trainee will complete an experiential learning requirement by observing an MDMA-Assisted Psychotherapy Session in a Healthy Volunteer study, representing 15 hours of training and valuable mentorship from an experienced MDMA therapist.
In addition to the practicum experience, if the MT2 protocol is approved, trainees may volunteer as a study participant to receive MDMA-assisted psychotherapy in a health volunteer study, if eligible. This Phase 1 clinical research protocol provides trainees with the opportunity to gain personal experience of the effects of MDMA administered in a therapeutic setting, which is likely to make a significant contribution to a therapist’s effectiveness in conducting psychotherapy with MDMA, and to offer valuable contributions to the safety profile of MDMA in healthy volunteers. Details will become available pending protocol approval.
Thank you for your patience with the hopeful and yet unpredictable nature of clinical research!
Applications remain open for the MDMA Therapy Training for Communities of Color, taking place August 11-17, 2019 in Louisville, Kentucky. This event is for eligible therapy providers, with priority registration for providers from and serving communities of color, especially those who are affiliated with an eligible facility or clinic where an MDMA-assisted psychotherapy protocol can be provided. In addition to this therapy training retreat, a public 1 ½ day Psychedelic Medicine and Cultural Trauma Community Workshop will take place on August 10th and 11th. These events are led by: Marcela Ot'alora G., MA, LPC, Lead MDMA Therapy Trainer, Clinical Investigator, and Monnica Williams, PhD, ABPP, Lead Culturally-Informed Therapy Trainer, Psychologist, with support from additional trainers. Eligible therapy providers interested in this event can submit the MDMA Therapy Training application for providers, and respond “yes” to the question about interest in the August MDMA Therapy Training for Communities of Color, as well as the associated questions about scholarship. More details for both events, including schedule, line-up of guest presenters, scholarship and registration fees will be available as they are updated at: https://maps.org/mdma-poc-training. Scholarships will be available for therapy providers and community organizers of color through the generous contributions of Open Society Foundation and several other pledges that are in the works! Details on scholarship will be posted online as soon as they are available.
Additional training retreats in the US will be announced via this newsletter as they are scheduled. Applicants who have already applied for the training program will automatically be considered for these events and will be notified when enrollment space is available and their application has been accepted.
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 clinician from a marginalized community, we encourage you to reach out to us at email@example.com.
MAPS MDMA-Assisted Psychotherapy Code of Ethics
The MDMA Therapy Training Program takes seriously our obligation to participant safety and to reflecting internally to promote ethical growth in our programs. We are committed to providing quality and comprehensive training and supervision to support therapy providers in delivering ethical care within MAPS MDMA-assisted psychotherapy protocols. In service to this commitment, the MDMA Therapy Training Program has established the MAPS MDMA-Assisted Psychotherapy Code of Ethics. This Code will be published in the MAPS Bulletin and posted online in the coming weeks. The Code will remain a living document to grow and adapt with the ongoing integration of feedback and evolution of needs over time.
Therapy providers completing the MDMA Therapy Training Program will agree to practice MDMA-assisted psychotherapy within their scope of competence and in accordance with the MAPS MDMA-Assisted Psychotherapy Code of Ethics, and will agree to directly address concerns regarding ethical issues and use clinical judgment, supervision, and consultation when ethical dilemmas arise.
The Training Program is Hiring!
MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Training & Supervision team. The Training Coordinator plays a major role in supporting trainees through the MDMA Therapy Training Program, from enrollment through Supervision and graduation. This position requires someone excited to engage with people, able to work well in a fast environment, and adept at organizing and managing lots of information online. Interested and qualified candidates are encouraged to apply online. Candidates who applied for the previous Admissions Coordinator position in the last four months will automatically be considered for this opening and do not need to submit a new application. People of color and people who identify as LGBTQIA+ are strongly encouraged to apply.
Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD now enrolling!
FDA-regulated Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD are currently recruiting participants who live within an hour’s drive of 15 clinic sites across the United States, Canada, and Israel.
The Phase 3 clinical trials are assessing the efficacy and safety of MDMA-assisted psychotherapy in adult participants with severe PTSD. Over a 12-week treatment period, participants will be randomized to receive either MDMA with psychotherapy or psychotherapy only. Assignment to the group will be blinded throughout the study, and all participants will have twelve preparatory and integration sessions lasting 90 minutes each along with three day-long sessions about a month apart.
The Phase 3 clinics are located:
San Francisco, CA | research institution
San Francisco, CA | private practice
Boulder, CO | private practice
Fort Collins, CO | private practice
New Orleans, LA | private practice
New York, NY | research institution
New York, NY | private practice
Charleston, SC | private practice
Madison, WI | research institution
Boston, MA | private practice
Montreal, Canada | private practice
Vancouver, Canada | research institution
Be’er Ya’akov, Israel | research institution
Tel HaShomer, Israel | research institution
If you know someone with PTSD interested in participating in a clinical trial or want to refer others, please visit this clinical trials recruitment page then click “Contacts and Locations” to find out which sites are recruiting to find more information to apply.
Open Call for Mental Health Providers:
Join the Psychedelic Support Network!
Psychedelic Support brings together a Network of clinics, therapists, counselors, doctors, and other specialists to offer services (online and in-person) for psychedelic/plant medicine integration, transformational preparation, psychological and physical health, and personal growth. Providers are required to be licensed in a health profession or be experienced as a therapist/guide in psychedelic-assisted research trials. Visit the website psychedelic.support to search provider profiles, find integration events and professional trainings, and access free resources from the collective knowledge of the Psychedelic Support Network. For more information or to apply, email firstname.lastname@example.org
While there are still many unknowns pending protocol review, we look forward to sharing with you regular updates on the MDMA Therapy Training Program. In the meantime, you may find some of the resources and trainings listed below helpful. Please also visit the MAPS PBC Therapy Provider Connect Portal for networking and information on MDMA PTSD Expanded Access. If you have any questions, please considering posting in the Connect Portal or emailing email@example.com.
We are excited about the possibility of bringing MDMA-assisted psychotherapy to many more communities and providing effective and ethical treatment to those suffering from PTSD. Thank you for your dedication to healing, growth, and liberation!
From the MDMA Therapy Training Program
“The mind is at every stage a theater of simultaneous possibilities.”
Williams James, as often quoted by Ralph Metzner (1936 - 2019)
Training Resources and Events:
Holos Ecopsychology Conference
April 6 - 7, 2019
Earthrise Retreat Center (IONS), Petaluma, CA
With presentations by MDMA Therapy Training staff members
Association for Transpersonal Psychology Conference
April 12 - 14, 2019
Pacific Grove, CA
Somatic Experiencing: A Workshop with Peter Levine
April 27, 2019
California Institute of Integral Studies, San Francisco, CA
Harm Reduction International Conference
April 28 - May 1, 2019
The Power Within: The Practice of Holotropic Breathwork
With Diana Medina
May 14 - 19, 2019
Connecticut River Valley, CT
Online interview with Kylea Taylor, author of “The Ethics of Caring: Honoring the Web of Life in Our Professional Healing Relationships”
May 18, 2019
American Psychiatric Association Annual Meeting
May 18 - 22, 2019
San Francisco, CA
With presentations from MAPS and MAPS PBC staff
Meditating with the Body California Retreat
With Caroline Pfohl and Manuela Mischke-Reeds, MA, MFT
May 19 - 24, 2019 and October 27 - November 1, 2019
Scotts Valley, CA
World Ayahuasca Conference
May 31 - June 2, 2019
Queering Psychedelics Conference
June 1 - 2, 2019
San Francisco, CA
Internal Family Systems Trainings
Generative Somatics Courses
Somatic Experiencing Trauma Institute Trainings
Hakomi Institute Trainings