MDMA Therapy Training Program, Summer 2019
Warm summer greetings from the Training Team at MAPS Public Benefit Corporation (MAPS PBC)!
Please see our updates on the status of the MDMA Therapy Training Program, upcoming training opportunities, and the Expanded Access protocol.
The MDMA Therapy Training Program has launched a series of trainings to prepare therapy providers to become eligible to work on a MAPS PBC MDMA PTSD protocol. On June 23 – 29, 2019 Annie Mithoefer, BSN, and Michael Mithoefer, MD led a six-and-a-half-day training retreat in Northern California focused on MDMA-assisted psychotherapy for PTSD. This retreat was hosted by the CIIS’ Center for Psychedelic Therapies and Research (CPTR) with support from the MDMA Therapy Training Program. More than 90 practitioners travelled from across the US and internationally to receive training.
The MDMA Therapy Training for Communities of Color took place August 10-17, 2019, in Louisville, Kentucky, and was led by Marcela Ot'alora M.A., L.P.C., and Monnica Williams, Ph.D., A.B.P.P., with support from additional trainers. The 1.5-day Psychedelic Medicine and Cultural Trauma Community Workshop took place August 10-11. In addition to twelve full scholarships for therapists and affiliated community organizers, tiered tuition pricing options were offered to the entire cohort. Additional scholarships programs are under development
Update from the Expanded Access Team
The MAPS Public Benefit Corporation (MAPS PBC) Expanded Access Team is currently working through a third round of questions from the U.S. Food and Drug Administration (FDA) regarding the proposed Expanded Access protocol for MDMA-assisted psychotherapy for treatment-resistant posttraumatic stress disorder (PTSD). While the team continues to move forward with the FDA on protocol negotiations, we wanted to share a progress update to keep you informed and ensure transparency.
The letter we received on July 11, 2019, from FDA made it clear they will only allow a limited number of patients to be enrolled to initiate our Expanded Access program and, has recommended that we start out by enrolling 50 patients. Even though this is not the initial sample size we requested, MAPS PBC is committed to starting the Expanded Access program and making effective treatment options available as soon as possible. MAPS PBC will agree with the FDA’s request to start by enrolling 50 participants in Expanded Access, with a plan to submit safety data from the first 35 patients to support a request to increase the enrollment number and therefore the number of Expanded Access sites. If there are no new safety concerns identified, we anticipate FDA will accept our proposal to increase the number of Expanded Access patients throughout the process of conducting Phase 3 clinical trials and New Drug Application (NDA) process.
At this time no Expanded Access sites have been selected. Over 100 sites have submitted a Site Questionnaire to undergo pre-screening to determine site eligibility. Pending protocol approval, MAPS PBC plans to start with 8-10 Expanded Access sites and add additional sites if we are able to increase our sample size. This will allow selected therapy pairs at each site to treat a small number of patients. We expect to hear back from the FDA on our responses to their latest round of questions in September.
The Expanded Access Team is grateful for the overwhelming interest in Expanded Access and future opportunities to deliver MDMA-assisted psychotherapy. Due to the level of interest and limited capacity dictated by FDA, not all interested sites will be able to participate. Growing this modality and making effective treatment options available is an ongoing process, and there are still significant uncertainties about timing and regulatory approvals. We are hopeful about making MDMA-assisted psychotherapy into a legal prescription treatment. Submitted applications will continue to be reviewed for site feasibility as we are able to add additional sites for Expanded Access or post-approval. All interested sites must undergo eligibility review and complete the pre-requisite MDMA Therapy Training Program in order to work on an MDMA PTSD protocol, Expanded Access or post-approval.
The Expanded Access Team is planning to schedule a meeting with applicants to discuss concerns and answer any questions. The team appreciates everyone’s patience and understanding during this process. We are incredibly grateful for your interest in this work and the continuing efforts to bring effective treatment options to those who need them most. We are very excited about the future of this work and your commitment to be on the forefront of treating PTSD with MDMA-assisted psychotherapy. The Expanded Access Team at MAPS PBC can be reached at ExpandedAccess@mapsbcorp.com.
While interest in psychedelic psychotherapy grows, we wanted to share some guidelines and suggestions for talking about your pending application to participate in a future MDMA PTSD protocol or post-approval. Compliance with FDA requirements regarding public communications about the treatment is important.
Please refer to MAPS Media Policy below:
MAPS Director of Strategic Communications, Brad Burge, will manage media requests. Please let Brad Burge know if you are contacted about Expanded Access by the media before you respond to the media representative.
Public announcements, press releases, web posts, emails to listservs and media, and social media posts specific to Expanded Access must be reviewed by Brad prior to release. In addition, if you are planning an event related to MAPS, Brad must be contacted prior to the event and all event promotional materials referencing MAPS require prior approval.
Brad Burge, Director of Strategic Communications, can be contacted at email@example.com.
How to Apply
There are two layers of application: 1) Site Questionnaire, and 2) MDMA Therapy Practitioner Training Application. Each site must submit one Site Questionnaire. Additionally, each therapy practitioner must submit an MDMA Therapy Practitioner Training Application. Only applicants affiliated with a qualifying site can be considered for training at this time.
Each application takes approximately 30 minutes to complete. You can save and return to work on your application at your convenience by creating a free Formsite account (highly recommended- instructions on first page of each application). Once you have completed the application, the final page will prompt you to confirm and submit. MAPS PBC will review applications on an ongoing basis, as they are received.
Sites and therapy providers inquiring to work on an MDMA PTSD protocol should be familiar and comfortable with the Treatment Manual before submitting an application. A full course of treatment involves three 90-minute Preparatory therapy sessions, three total 8-hour MDMA therapy sessions, and nine total 90-minute Integrative therapy sessions, summing about 42 hours of therapy. All sessions are administered by a Therapy Pair, two providers for every one participant/patient, utilizing a non-directive approach and an ability to work with extreme states. More information about the therapeutic approach can be found in the MDMA-Assisted Psychotherapy Treatment Manual and in in Cultivating Inner Growth: The Inner Healing Intelligence in MDMA-Assisted Psychotherapy.
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.
Additional site and practitioner application procedures are posted at
https://mapspublicbenefit.com/. If you have already submitted an application for your site and therapy teams, thank you! The training team will be in touch with you. The MPBC clinical operations team is currently reviewing site questionnaires to screen for initial eligibility and the training team is reviewing therapy provider applications.
The MDMA Therapy Training Program Fall retreat is now scheduled for October 1 - October 8, 2019 in Asheville, North Carolina. The training will be led by Annie Mithoefer, BSN, and Michael Mithoefer, MD. Additional training retreats will be announced via the training newsletter as they are scheduled.
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 MDMA-assisted psychotherapy protocols. In service to this commitment, the MDMA Therapy Training Program has established the MDMA-Assisted Psychotherapy Code of Ethics. The Code of Ethics was published in the recent MAPS Bulletin and is available online for your reference and review.
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 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.
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 share our new recruitment website https://mdmaptsd.org/
for more information and our Phase 3 trial application.
Open Call for Mental Health Providers:
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 email@example.com
MAPS PBC Therapy Provider Connect Portal
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 an MDMA PTSD Expanded Access protocol, pending FDA approval. If you are looking for treatment staff, a physician, or a treatment facility, or for general information and Frequently Asked Questions, we hope that this platform will support you.
Within the Connect Portal there are two main sections: “General Forum” and “Regions.” The General Forum is a central place to locate information and answers to questions about eligibility, training, and the MDMA PTSD Expanded Access program that are not specific to a particular region. Resources such as planning and procedural templates for sites will be posted in the General Forum as they become available. After registering, please read the General Forum and browse the Treatment Manual.
To connect with others in your region, navigate to the Regions Forum, select your Region, then select a State or Territory. If you are seeking treatment staff, a physician, or a treatment facility, make a post in the section for that State or Territory. Use clear and descriptive language in your posting titles, such as “Somatic therapist seeking site near Omaha.”
We will continue to provide updates on the MDMA Therapy Training Program and MAPS PBC protocols when they available. In the meantime, you may find some of the resources and trainings listed below helpful. Please also visit our new website https://mapspublicbenefit.com/ and the Connect Portal for additional information. If you have any questions, please considering checking the FAQ in the Connect Portal or emailing firstname.lastname@example.org.
We appreciate your patience and continued support as we work to bring the healing potential of MDMA-Assisted Psychotherapy for PTSD to those in need.
From the MDMA Therapy Training Program
"At the height of laughter, the universe is flung into a kaleidoscope of new possibilities."
– Jean Houston
Training Resources and Events:
28th Annual Internal Family Systems Conference