MDMA Therapy Training Program, May 2019
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 MDMA PTSD protocol. On May 4 - 11, 2019 53 therapists, doctors and counselors gathered 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 sites across 13 states. International guests hailed from Israel and Canada. In service to promoting awareness surrounding ethics, diversity and inclusion, trainees from the May cohort participated in a workshop on Power, Privilege, and Diversity led by Dr. Gaia Mika and received a presentation on the newly published MAPS MDMA-Assisted Psychotherapy Code of Ethics.
In January 2019, MAPS Public Benefit Corporation (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. 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. The FDA's website has more information on its Expanded Access program.
The FDA responded to MAPS PBC’s initial submission and requested some additional clarifications and protocol changes. The Expanded Access Team at MPBC responded to the agency addressing their questions and received a response back from the agency mid-May with additional questions. The Expanded Access Team is currently working through this second round of questions from the FDA, with plans to submit early-June. A response from the FDA is expected in mid-July. MAPS/MAPS PBC is committed to working with the agency to ensure everyone involved feels comfortable with the final protocol.
While the Expanded Access Team is still negotiating certain aspects of the protocol with the FDA, we will continue to move forward. At this time no sites have been through a final selection to participate in Expanded Access. MAPS PBC will start the confirmation of sites after FDA and IRB clearance and continue throughout the program. Sites will require approval by MAPS/MAPS PBC, the site’s IRB and local DEA (including obtaining a Schedule 1 license) to complete final site selection. Expanded Access is expected to start slowly with a small number of sites and will continue to grow with the addition of more sites over the life of the program.
The Expanded Access Team appreciates everyone’s patience and understanding as we continue to navigate such a large-scale program. We are incredibly grateful for everyone’s interest in this work and the continuing efforts to bring effective treatment options to those who need them most.
Training Application Updates
Qualified sites in the US and US Territories interested in being considered to participate in an MDMA PTSD protocol, 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 the MDMA Therapy Training Program, and 3) Prescribing Physician who can obtain a DEA Schedule 1 license for MDMA.
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 email@example.com.
Additional site and practitioner application procedures are posted at maps.org/training.
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.
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 MA, LPC, and Monnica Williams, PhD, ABPP, with support from additional trainers. There are two parts to this event: a 1 ½ day Psychedelic Medicine and Cultural Trauma Community Workshop (guest presenters will be added to this website as they are announced) and a week-long MDMA-assisted Psychotherapy Training Retreat with a focus on Therapists of Color. The Workshop is open to the public; the MDMA Therapy Training is for eligible therapy providers who have been accepted into the training program, with a focus on providers from and serving communities of color, with priority registration for providers who are affiliated with a potential Expanded Access site. 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 this event, including exact location, schedule, scholarship and registration fees will be available as they are updated at: https://maps.org/mdma-poc-training. Scholarships and tiered tuition rates are currently available for the Communities of Color training through funding from the Open Society Foundation, Libra Foundation, Riverstyx, Psychedelic Science Funders Collaborative, and Dr. Bronner’s Magic Soaps. Applicants who applied for this event will receive more information about the scholarship process. Additional scholarship programs are under development.
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, BSN, and Michael Mithoefer, MD. 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.
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 visit this clinical trials recruitment page then click on the sites that are recruiting to find more information to apply.
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 firstname.lastname@example.org
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 maps.org/training and the MAPS PBC Therapy Provider Connect Portal for additional information. If you have any questions, please considering checking the FAQ in the Connect Portal or emailing email@example.com.
We deeply appreciate your continued interest and support in the healing potential of MDMA-Assisted Psychotherapy for PTSD.
From the MDMA Therapy Training Program
“Ours is not the task of fixing the entire world all at once, but of stretching out to mend the part of the world that is within our reach. Any small, calm thing that one soul can do to help another soul, to assist some portion of this poor suffering world, will help immensely. It is not given to us to know which acts or by whom, will cause the critical mass to tip toward an enduring good.
What is needed for dramatic change is an accumulation of acts, adding, adding to, adding more, continuing. We know that it does not take everyone on Earth to bring justice and peace, but only a small, determined group who will not give up during the first, second, or hundredth gale.
One of the most calming and powerful actions you can do to intervene in a stormy world is to stand up and show your soul.
Struggling souls catch light from other souls who are fully lit and willing to show it.”
-Dr. Clarissa Pinkola Estés
Training Resources and Events:
Chapel of Sacred Mirrors (CoSM)
5 part online series. May 30th, June 6th, 13th, 20th, 27th.