MDMA Therapy Training Program

Fall 2017 Update



Season’s Greetings from MAPS Public Benefit Corporation (MPBC)! We hope you are well, enjoying good health and prosperity!



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 future opportunities in the US and abroad.



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. Eighty-two researchers will provide MDMA-assisted psychotherapy for severe PTSD at sites across the US and Canada. The first study participants are in screening now!



Although there are no current job openings for researchers with MAPS, and the MDMA Therapy Training Program is not accepting applications at this time, there are opportunities to look forward to! Read on…!



If you haven’t familiarized yourself with the MDMA-assisted psychotherapy Treatment Manual and Investigator’s Brochure, I encourage you to read these materials! These documents outline the structure of therapy sessions, from practical considerations to therapeutic orientation. The course of treatment consists of about 65 hours of therapy across four to five months. Every therapy session is conducted by a Therapy Pair, two providers for every one participant. Experimental Sessions are 8-hour therapy sessions, and take place a total of three times. The study participant stays overnight at the study site after their experimental session and undergoes an extensive integration process lasting three to five weeks.



Expanded Access



Expanded Access is an FDA program that allows the use of an investigational drug outside of a clinical trial. The program is designed to address urgent and life-threatening conditions in patients who don’t currently have promising treatment options. You can learn more about Expanded Access on the FDA's website.



If Expanded Access is approved, new sites meeting the requirements below can seek approval to be part of MPBC's multi-center Expanded Access protocol, which will 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.



Therapy Team - 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 will work under the direct supervision of the licensed team member

Medical Doctor (MD) or Doctor of Osteopathy (DO)

- One person licensed to manage and administer controlled substances for each site

- Ability to obtain DEA Schedule 1 license after the protocol is approved

- A physician to assess participant safety



Facility

- Accessible and Private

- 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

- Note distance to nearest hospital

- If possible/needed, space for more than one therapy pair to treat patients

- Two rooms for overnight stays (participant and night attendant)

- High-speed wired Ethernet (in addition to Wi-Fi)

- Ability to install recording and sound equipment in the therapy room

- Office area for administration needs of the business, medical records storage

On December 20th MPBC will meet with the FDA to discuss Phase 3 and Expanded Access. We look forward to sharing further updates as we learn more. MPBC is not currently accepting applications for the training program or Expanded Access, there is not a waiting list. Thank you for your patience, please stay tuned!



In the meantime, you may expand your skill and knowledge through the tools and trainings listed below. 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 interest and dedication to this work!



We wish you a restful and rejuvenating Holiday Season!





From the MDMA Therapy Training Program!



If a thing is worth doing, it is worth doing well. If it is worth having, it is worth waiting for. If it is worth attaining, it is worth fighting for. If it is worth experiencing, it is worth putting aside time for.

-Oscar Wilde



There is some good in this world, and it's worth fighting for.

-J. R. R. Tolkien

RESOURCES

The resources listed below are materials related to the topics of trauma, non-ordinary states of consciousness, clinical research, and bodywork. The organizations listed are not affiliated with MPBC.



Holotropic Breathwork

https://www.holotropic.com/schedule.shtml

January 20-21 The Holotropic Shift and The Power Within; Tav Sparks, Michael Stone, & Stacia Butterfield in San Francisco

January 30-February 4 Spiritual Emergency: Embracing Unexpected Transformation; Tav Sparks, Diane Haug in Joshua Tree, CA

February 6-11 The Psychedelic Experience: Promises and Pitfalls; Diane Haug in Joshua Tree, CA

May 15-20 Music and Transcendence; Tav Sparks, Stacia Butterfield in Chester, CT



Workshops at Esalen

https://www.esalen.org

Psychedelic Medicines and the Mind

February 2-4 with David Presti and Kristi Panik MD

The I in the Storm: Bringing Self Leadership to Everyday Life

February 4-9 with Richard Schwartz

Trauma, Memory and the Restoration fo One’s Self

February 4-9 with Bessel van der Kolk and Licia Sky



Diaphragmatic Breathing App by DCoE

Breath2Relax App (free)

Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury

Monthly Webinars: http://www.dcoe.mil/training/education

Mind-Body Skills for Regulating the Autonomic Nervous System



National Center for PTSD

https://www.ptsd.va.gov/professional/index.asp



VA/DoD Clinical Practice Guidelines

Management of Posttraumatic Stress Disorder and Acute Stress Reaction 2017



Somatic Experiencing (SE)

Somatic Experiencing for Posttraumatic Stress Disorder: A Randomized Controlled Outcome Study

Training Programs



Polyvagal Theory

Stephen Porges

http://stephenporges.com/index.php/videos



Trauma Resilience Model (TRM) and Community Resilience Model (CRM)

https://www.traumaresourceinstitute.com/home/

Trainings in the US for clinicians and community members.

iChill app



Tension and Trauma Release Exercises (TRE)

Workshops and trainings in the US, Europe, Asia.

https://traumaprevention.com/event-calender/







Wishing you well,



Shannon Clare Carlin, MA

MDMA Therapy Training Program

MAPS Public Benefit Corporation (MPBC)

training@mapsbcorp.com