Spring 2018 Update
Happy Spring from MAPS Public Benefit Corporation (MPBC)!
It is a pleasure 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 updates about upcoming opportunities through the anticipated US FDA Expanded Access Program.
The MDMA Therapy Training Program, operated by MPBC, 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 Phase 3 trial sponsored by MAPS, which is set to begin this summer. 82 researchers will provide MDMA-assisted psychotherapy for severe PTSD at 16 sites across the US, Canada, and Israel. We have completed the selection of the team of Phase 3 therapists, who are currently completing the supervision phase of training. Once Phase 3 participant recruitment is complete, MAPS will apply for the FDA Expanded Access Program. 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.
Expanded Access Updates
Expanded Access is a US FDA program that allows the use of an investigational drug under a Treatment Protocol. The program is designed to address urgent and life-threatening conditions in patients who do not currently have promising treatment options. Only sites within the US and US territories are eligible to participate in the US FDA Expanded Access Program. We hope to apply for similar programs internationally, at a later date. You can learn more about Expanded Access on the FDA’s
If Expanded Access is approved, new sites meeting the requirements listed below may seek approval to participate in MPBC's multi-center Expanded Access protocol, which would allow them to administer open-label MDMA-assisted psychotherapy for PTSD. 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.
Currently MPBC is updating its website, including web pages for the Therapy Training Program. We hope to have an online training application for eligible Expanded Access sites and providers later this year. Training for Expanded Access providers is anticipated to start in 2019. While we are not yet accepting applications and do not have a wait list for potential Expanded Access providers, here are some details so you can familiarize yourself with the Expanded Access requirements for sites and therapy teams:
- One or more therapy pairs, each pair consisting of two providers
- One person per therapy pair is required to be licensed to provide psychotherapy, according to state and local requirements
- If one person on the therapy pair is unlicensed, they must display sufficient training in therapeutic communication, ethics, and trauma, and will work alongside of the licensed team member
- All providers must complete the MDMA Therapy Training Program (approx. 100 hours plus Supervision)
- All providers must undergo Supervision, which requires the treatment of the first patient to be completed pro-bono, and video-taped for review by a Supervisor
- At least one person at each site licensed to manage and administer controlled substances
- Ability to obtain DEA Schedule 1 license after the protocol is approved
- DEA Schedule 1 license holder would be responsible for the management, administration, and storage of MDMA at the site
- A physician to assess participant safety
- Accessible and private
- An established business entity, with standard business operations
- Has a system in place for paying providers and billing clients
- Meets zoning and rental stipulations for medical treatment and therapy
- Drug storage in line with regulatory requirements
- Can pass DEA inspection for Schedule 1 license
- Has at least one room where 8-hour psychotherapy sessions can take place, with enough space for a couch or futon, and two comfortable chairs (one for each therapy provider)
- If possible/needed, space for more than one therapy pair to treat patients
- Two rooms for overnight stays (participant and night attendant)
- Bathroom that is easily accessible from the therapy room
- High-speed wired Ethernet (in addition to Wi-Fi)
- Ability to install recording and sound equipment in the therapy room
- Office area for administrative needs, medical records storage
If you haven’t familiarized yourself with the MDMA-assisted psychotherapy Treatment Manual
and Investigator's Brochure
, we encourage you to read these materials! These documents outline the structure of therapy sessions, from practical considerations to therapeutic orientation.
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 Spring season and 2018!
From the MDMA Therapy Training Program!
How surely gravity’s law,
strong as an ocean current,
takes hold of the smallest thing
and pulls it toward the heart of the world...
- Rainer Maria Rilke
In a voiced community, we all flourish.
- Terry Tempest Williams
Resources and Extracurricular Trainings
Articles and Lectures:
MDMA Therapy Training Program: Update on Supervision Process and Expanded Access
Shannon Clare Carlin, MDMA Therapy Training Program Manager
Potential Psychiatric Uses for MDMA
by Berra Yazar-Kloskinski and Michael C. Mithoefer
VA PTSD Consultation Program Lecture Series
Watch past lectures, including:
Present-Centered Therapy for PTSD by Paula Schnurr, PhD and Tracie Shea, PhD
Written Exposure Therapy for PTSD by Denise Sloan, PhD, and Brian Marx, PhD
Assessing and Managing Violence Risk in Veterans with PTSD by Eric Elbogen, PhD
Responding to the Yountville Shooting: Taking Care of Your Patients and Yourself after Tragedy by Sonya Norman, PhD and Patricia Watson, PhD
Posttraumatic Stress Disorder: An Integrated Overview of the Neurobiological Rationale for Pharmacology
by Kelmendi, Adams, Southwick, Abdallah, Krystal
MDMA-assisted psychotherapy for PTSD: Are memory reconsolidation and fear extinction underlying mechanisms?
by Allison A. Feduccia and Michael C. Mithoefer
Trainings and Events:
Holotropic Breathwork Workshops and Integration with Mireya A. Marcet
Grof Transpersonal Training
Sensorimotor Psychotherapy Institute Upcoming Trainings
Somatic Experiencing Upcoming Trainings
Hakomi Institute of California’s “From Trauma to Dharma” Training
taught by Manuela Mischke-Reeds, MA, MFT
Internal Family Systems International Trainings
Appearances by Dr. Richard Schwartz
Webinar on "The Power of Internal Family Systems"
with Richard Schwartz and Pamela Krause
Beyond Psychedelics Conference
Prague, Czech Republic
June 22 - 24, 2018
Los Angeles Psychedelic Science Symposium (LAPSS)
UCLA, Los Angeles, CA
June 22 - 23, 2018
Please visit the MAPS Newsletter
for other events and articles related to psychedelic research and education.