Summer 2018 Update
Happy Summer from MAPS Public Benefit Corporation (MPBC)!
We are delighted to send you this update on current and planned clinical trials exploring MDMA-assisted psychotherapy, as well as the status of the MDMA Therapy Training Program and upcoming opportunities through the U.S. Food and Drug Administration (FDA) Expanded Access (EA) Program, pending approval.
The MDMA Therapy Training Program functions to train researchers to conduct MDMA-assisted psychotherapy in approved clinical trials. For the past two years, the training program’s goal has been to prepare researchers to work on a multi-site MAPS-sponsored Phase 3 trial researching MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD), planned to start in the coming months in the United States, Canada, and Israel. These 82 therapists are in the midst of our supervision program, which will be an integral part of our training program going forward. The results of the Phase 3 studies will support a New Drug Application (NDA) to the FDA to make MDMA-assisted psychotherapy into a legal prescription medicine, anticipated to take place in 2021. 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.
From June 24-20, 2018, MAPS-sponsored researchers Dr. Michael Mithoefer and Annie Mithoefer, BSN, led a training in Marshall, Calif., in MDMA-assisted psychotherapy for PTSD for approximately 90 students, the largest group MDMA therapy training ever conducted. The trainees consisted of students in the California Institute of Integral Studies (CIIS)’ Certificate in Psychedelic-assisted Therapies and Research (CPTR) program, plus about 30 guests, including a large proportion of medical doctors and psychotherapists, including visiting clinicians and researchers from Israel, the Czech Republic, and Puerto Rico.
From July 16-19, 2018, MAPS-sponsored researchers Dr. Michael Mithoefer and Annie Mithoefer, BSN, Marcela Ot’alora, and Bruce Poulter, together with MAPS Executive Director Rick Doblin, Ph.D., MPBC Executive Director Amy Emerson and MPBC Associate Director of Training and Supervision Shannon Carlin participated in a four-day meeting in Boulder, Colo., to further develop the training program for MAPS-sponsored MDMA researchers and potential Expanded Access sites. Work included adapting the program for a larger audience, planning refinements to the Treatment Manual (maps.org/treatmentmanual), conducting a revision of the online training module (Part A), and building a standard format for in-person therapy trainings. The purpose of these adaptations is to prepare for the upcoming FDA Expanded Access program in 2019, which will involve a massive expansion of the number of people participating in these trainings.
MAPS and MPBC are excited to support the development of MDMA-assisted psychotherapy for PTSD research in Europe and South America. Approximately 60 therapists and researchers will attend a training in the Netherlands this fall, led by Annie Mithoefer, BSN and Michael Mithoefer, BSN to prepare potential sites to conduct Phase 3 trials in Europe. Another training is planned this fall, led by Marcela Ot’alora, LPC to prepare researchers in Columbia and Chile.
Currently MPBC is updating its website, including web pages for the Therapy Training Program. We intend to have an online training application for eligible sites and providers later this year.
Complete applications for potential sites to work on a U.S. FDA Expanded Access protocol for MDMA-assisted psychotherapy will be reviewed on an ongoing basis, starting late 2018 and continuing through the duration of the protocol, pending approval. Registration for the first training cohort will take place early 2019. An outline of the training program is provided below. The next residential training event will take place in the U.S. March 2019, exact location and dates to be determined. Additional training events will take place following March 2019, in locations across the U.S..
MDMA Therapy Training Program Outline:
(subject to change)
- Part A: Online Course (14 hours) outlines chemistry and history of MDMA, common reactions, possible mechanisms of action, and study design. The online course was developed out of content from the Treatment Manual, study protocols, and scientific literature on the subject.
- Part B: Residential Training (7 days- 50 hours) therapy video review and live dialogue with Senior MDMA-assisted Psychotherapy Researchers, covers topics in the Treatment Manual. Trainees are taught how to conduct study sessions, provide non-directive therapy, and adhere to study protocol.
- Part C: Experiential Elective, each trainee must complete an experiential elective, options include: participating in FDA-regulated clinical trial offering MDMA-assisted psychotherapy to professionals training to become providers in the modality, Holotropic Breathwork workshop, or equivalent experience to be determined.
- Part D: Role Play (6 hours) Therapy Teams from a given site gather to conduct role play didactic training. Role play scenarios will be provided, each trainee gets a chance to play the role of provider, participant, and observer. The role plays will be video and audio recorded so that recording may be reviewed by a Supervisor.
- Part E: Supervision and Evaluation, trainees receive in-depth video review and clinical supervision during the treatment of their first participant receiving MDMA-assisted psychotherapy. Therapy sessions for that participant would be audio and video recorded so that recordings may be viewed by a Senior MDMA-assisted Psychotherapy Researcher. A final evaluation is provided at the completion of supervision; trainees who have satisfied all of the training requirements are granted a certificate of completion.
To date, the MDMA Therapy Training Program has enrolled 370 trainees, all of whom have attended a week-long residential training. Forty-four trainees have completed Supervision and another 40 are currently undergoing Supervision. Sixty-five participants have been treated in our FDA-regulated clinical trial offering MDMA-assisted psychotherapy for professionals training to become providers in the modality.
The MDMA Therapy Training Program is not currently accepting applications. For those in the U.S. interested in Expanded Access, the information below will help familiarize yourself with our current understanding of the program and anticipated application requirements.
Expanded Access Updates
In the coming year, MAPS will apply for a special U.S. Food and Drug Administration (FDA) program called Expanded Access, which allows the use of an investigational medical product (one that has not yet been approved by the FDA) outside of a clinical trial. The program’s purpose is to grant access to potentially beneficial investigational treatments for people 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.
If Expanded Access for MDMA-assisted psychotherapy for PTSD is approved, new sites in the U.S. meeting the requirements may obtain approval and undergo training to administer open-label MDMA-assisted psychotherapy to eligible patients with treatment-resistant PTSD, under a MAPS protocol. Qualified applicants will have a team of therapy providers, a physician, and a facility suitable to conduct MDMA-assisted psychotherapy with approval by regulatory agencies. In the coming years, MAPS may be able to apply for similar programs abroad.
The basic requirements of a qualified clinic are: 1) a suitable facility to conduct MDMA-assisted psychotherapy and meet drug storage requirements, 2) qualified therapy team who have completed the MDMA PTSD Therapy Training Program, operated by MPBC, 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.
Please read the MDMA-Assisted Psychotherapy for PTSD Treatment Manual and Investigator's Brochure for a full description of the modality. Applicants should be familiar and comfortable with the protocol. It is important to understand that a full course of treatment in the MDMA-assisted psychotherapy protocol (pending revisions) involves three 90-minute preparatory therapy sessions, three total 8-hour MDMA therapy sessions, and nine total 90-minute integrative therapy sessions, summing 42 hours of therapy across 13-26 weeks. There may be additional visits for screening, follow-up, phone contact, and in case of emergency. All sessions are administered as a Therapy Pair, two providers for every one participant/client, utilizing a non-directive approach and an ability to work with extreme states.
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 from the LGBTQ community. If you are a therapist from a marginalized community, we encourage you to reach out to us.
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 Summer season and 2018!
From the MDMA Therapy Training Program!
As great scientists have said and as all children know, it is above all by the imagination that we achieve perception, and compassion, and hope.
- Ursula Le Guin
Conferences and Events:
Moshe Kasher and Friends: a Benefit for MAPS
Los Angeles, CA
August 13, 2018
Rethinking Drug Policy: Social Justice in the Psychedelic Renaissance
With Natalie Ginsberg and Ismail Ali, MAPS Policy and Advocacy Team
San Diego, CA
August 15, 2018
Cultural and Political Perspectives on Psychedelic Science
CIIS, San Francisco, CA
August 18 – 19, 2018
Horizons: Perspectives on Psychedelics
New York, NY
October 5 – 7, 2018
Colloquium on Psychedelic Psychiatry
October 13 – 14, 2018
Science and Nonduality Conference
San Jose, CA
October 24 – 28, 2018
Portland Psychedelic Society Conference
October 27, 2018
Kriya: Ketamine Research Conference
November 3 – 4, 2018
Understanding and Assessing Racial Trauma
With MAPS Therapist Monnica Williams PhD
at International Society for Traumatic Stress Studies
November 8 – 10, 2018
Resources and Articles:
MAPS Psychedelic Integration Resource List
Conversations on Compassion
Online speaker series
Do Psychedelics Have the Power to Change Minds?
By Alli Feduccia, PhD
Maggie Elizabeth tells us about doctors giving her MDMA to treat her PTSD
Facing the Shadow: Community Discussions on Diversity, Race, and Privilege
Video of AWARE Project Panel including Ismail Ali, J.D., MAPS Policy and Advocacy Counsel
The Ethics of Caring: Honoring the Web of Life in Our Professional Healing Relationships
Book by by Kylea Taylor, focuses on ethics of working therapeutically with non-ordinary states of consciousness
Healing Complex & Developmental Trauma with NARM with Brad Kammer
Addicted Mind Podcast
Please visit the MAPS Newsletter for other events and articles related to psychedelic research and education.