Researchers Prepare for Decisive FDA Meeting this Month
Promising results from Phase 2 trials of MDMA-assisted psychotherapy for PTSD
November 10, 2016
Dear friends and supporters,
As the dust settles from a traumatizing election year, we have many opportunities to turn our attention towards healing, and to creating a more compassionate world. That’s why I’m grateful to share with you the unprecedented progress the Multidisciplinary Association for Psychedelic Studies (MAPS) has been making with the support of our global community.
This month, on November 29, we’ll meet with the U.S. Food and Drug Administration (FDA) to agree on the design of our upcoming Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). Phase 3 trials are the final stage of research required by the FDA, prior to deciding whether to make MDMA-assisted psychotherapy a legally available treatment option.
Our overall Phase 2 study results have been extremely promising, having treated 107 subjects with chronic PTSD. 53% of 74 participants no longer qualified for PTSD after two to three MDMA-assisted psychotherapy sessions, compared to 23% who received placebo or comparator dose. Of 65 subjects interviewed one year after treatment, 66% no longer had PTSD.
In the November 2016 edition of the MAPS Email Newsletter, you’ll also learn:
- Advance Tickets for Psychedelic Science 2017 are available until November 15 at midnight PST — register before the deadline to save 15%!
- Two more participants enroll in our ongoing MDMA-assisted psychotherapy training study for clinical trial therapists
- The 12th participant is enrolled in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness
- The 12th and final participated is treated in our study of MDMA-assisted therapy for social anxiety in autistic adults
- The newest MAPS-published book, The Ketamine Papers: Science, Therapy, and Transformation, edited by Phil Wolfson, M.D., and Glenn Hartelius, Ph.D., is now available for pre-orders in the MAPS Store.
Spread the word and stay connected by following us on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.
Our culture is undeniably at a moment of change. By healing trauma, expanding opportunities for creativity, spirituality, and personal growth, and reducing the stigma on psychedelic experiences, we can create a safer, more compassionate world for ourselves and for future generations.
Always upwards,
Brad Burge
MAPS Director of Communications and Marketing
P.S. Tickets are selling fast for Psychedelic Science 2017 — with especially limited capacity for the Sunset Cruise and Psychedelic Comedy Banquet.
Contents
Treating PTSD with MDMA-Assisted Therapy
1 Phase 3 Trials: FDA Receives End of Phase 2 Documents
2 U.S. Veterans: Study Officially Completed
3 Canada: Final Participant Completes 12-Month Follow-Up
4 Boulder: 20th Participant Completes 12-Month Follow-Up
5 Israel: Fourth Participant Completes 12-Month Follow-Up
7 Therapy Training Program: Group Training Takes Place in New York
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
8 Marin: 12th Participant Treated
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
9 Social Anxiety in Autistic Adults: 12th Participant Treated
Ayahuasca Research
Psychedelic Harm Reduction
11 Zendo Project: Fundraising Success, Event Updates, and More
Support MAPS
12 October Giving Report: Support for the Future of Psychedelic Medicine
Media
13 KQED, Rolling Stone, Mad in America, and more…
MAPS Store
14 Ayahuasca Reader: Encounters with the Amazon’s Sacred Vine
15 NEW The Ketamine Papers: Science, Therapy, and Transformation
Events
16 Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
17 “A Good Trip” Tour with Comedian Shane Mauss: November 10, 2016-January 25, 2017
19 Discovering the Way of the Psychonaut
20 KRIYA Institute Ketamine Conference: November 12-13, 2016, Hillsborough, CA
21 MDMA-Assisted Therapy for Social Anxiety in Autistic Adults: November 18, 2016, San Francisco, CA
More News
23 MAPS Public Benefit Corporation (MPBC) is Hiring
24 The Shulgin Archive Launches Crowdfunding Campaign
25 CIIS Certificate Program Opens Enrollment
26 Journal of Psychedelic Studies Accepting Manuscript Submissions
Research-grade MDMA is prepared for upcoming MDMA-assisted psychotherapy treatment sessions.
Treating PTSD with MDMA-Assisted Therapy
Phase 3 Trials: FDA Receives End of Phase 2 Documents
On October 12, 2016, the U.S. Food and Drug Administration (FDA) confirmed their receipt of MAPS’ materials in support of our End of Phase 2 meeting with the FDA, scheduled for November 29, 2016. The submission included a 90-page summary of initial indications of safety and efficacy based on our Phase 2 results, plus what is now known about the toxicology, pharmacology, and abuse liability of MDMA from over 5000 peer-reviewed scientific papers published on MDMA or Ecstasy. We also had multiple attachments consisting of our Chemistry, Manufacturing, and Control (CMC) proposal for MDMA production under current Good Manufacturing Practice (cGMP) standards for Phase 3 and post-approval formulation, toxicological study proposals, key elements of MDMA-assisted psychotherapy, and key references. The goal of our End of Phase 2 Meeting will be to come to an agreement on the design of our upcoming Phase 3 trials, the final stage of research required to gather evidence proving safety and efficacy sufficient for FDA to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD. Learn more…
U.S. Veterans: Study Officially Completed
On October 27, 2016, MAPS Public Benefit Corporation (MPBC) staff met with investigators in Charleston, South Carolina for the formal closeout of our largest Phase 2 study of MDMA-assisted psychotherapy in 24 U.S. veterans, firefighters, and police officers with chronic, treatment-resistant PTSD. Conducted by Clinical Trial Leaders Rebecca Matthews and Alli Feduccia, Ph.D., the closeout included a thorough review of the study’s documentation, database, files, and adherence to regulations. All treatment sessions and long-term follow-up interviews for this study have now been completed. Led by Principal Investigator Michael Mithoefer, M.D., and Co-investigator Annie Mithoefer, B.S.N., in Charleston, South Carolina, the data from this study are now being prepared for analysis and publication in a peer-reviewed scientific journal. Learn more…
$1,449,000estimated study cost | $1,449,000raised | Funding Complete |
Donate Nowhelp fund more research |
Canada: Final Participant Completes 12-Month Follow-Up
On October 17, 2016, the sixth and final participant completed their 12-month follow-up interview in our Phase 2 pilot study of MDMA-assisted psychotherapy for PTSD in Vancouver, Canada. All participants have completed treatments and long-term follow-up interviews. This small pilot study gave Canadian therapists experience delivering MDMA-assisted psychotherapy for PTSD, with data collected from three women and three men. The final results are being prepared for publication as a part of a global meta-analysis of MDMA-assisted psychotherapy results. Learn more…
$479,000estimated study cost | $48,000raised$69,000raised by partners | $353,000still needed |
Donate
|
Boulder: 20th Participant Completes 12-Month Follow-Up
On October 17, 2016, the 20th participant out of 23 completed their 12-month follow-up interview in our Phase 2 study of MDMA-assisted psychotherapy in 23 subjects with chronic, treatment-resistant PTSD in Boulder, Colorado. These data will provide additional information to guide the design of our upcoming Phase 3 trials. The final results are being prepared for publication, which is expected in 2017. Learn more…
$802,000estimated study cost | $802,000raised | Funding Complete |
Donate Nowhelp fund more research |
Israel: Fourth Participant Completes 12-Month Follow-Up
On October 21, 2016, the fourth of 10 participants completed their 12-month follow-up interview in our Israeli Phase 2 study of MDMA-assisted psychotherapy for PTSD. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study has treated 10 subjects with chronic, treatment-resistant PTSD from any cause. Learn more…
$509,000estimated study cost | $509,000raised | Funding Complete |
Donate Nowhelp fund more research |
Therapist Training Study: Two More Participants Enrolled
On September 28, 2016, the 15th participant was enrolled at our study site in Charleston, South Carolina in our ongoing Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. The Charleston site is led by Principal Investigator Michael Mithoefer, M.D. On October 23, the third participant was enrolled at the recently initiated Boulder, Colorado study site. Marcela Ot’alora, M.A., L.P.C., is serving as Principal Investigator of the Boulder site. Enrollment in this study is limited by invitation only to therapists in training to work on MAPS-sponsored clinical trials of MDMA-assisted psychotherapy for PTSD. This study has currently enrolled 18 out of 100 participants across both study sites. Learn more…
$429,000estimated study cost | $35,000raised | $394,000still needed |
Donate Nowhelp fund more research |
Therapy Training Program: Group Training Takes Place in New York
From October 16-22, 2016, 25 trainees gathered in Stony Point, New York, to participate in Part B of the MDMA Therapy Training Program. The five-part training program is currently preparing therapy teams for upcoming MAPS-sponsored Phase 3 trials of MDMA-assisted psychotherapy for PTSD. Part B of the program is a week-long training led by MAPS-sponsored researchers Michael Mithoefer, M.D., Annie Mithoefer, B.S.N., and Marcela Ot’alora, M.A., L.P.C. Since December 2014, the training program has enrolled 121 people with a background in mental health or medicine. Another 40 trainees are registered for a Part B training taking place in January 2017, the last cohort entering the program before Phase 3 is planned to start next year. The program is a prerequisite for anyone working on a therapy team in a MAPS-sponsored Phase 3 trial. All Phase 3 researchers will also complete Parts C-E of the training program, which include an external workshop, a second week-long training, a final evaluation, and clinical supervision. At this point the training program is not accepting applications, however you can sign up to receive updates when future training opportunities become available. Sign up and learn more…
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: 12th Participant Treated
On October 24, 2016, the 12th participant was treated in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif. Led by Principal Investigator Phil Wolfson, M.D., with Co-therapist Julane Andries, L.M.F.T., this study is gathering preliminary data about the safety and efficacy of MDMA-assisted psychotherapy for anxiety in 18 subjects diagnosed with a life-threatening illness. We are currently screening additional participants for this study. Learn more…
$627,000estimated study cost | $218,000raised | $409,000still needed |
Donate Nowhelp fund more research |
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
Social Anxiety in Autistic Adults: Final Participant Treated
On October 29, 2016, the 12th and final participant received their last blinded experimental session in our ongoing study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum. Sponsored by MAPS, this is a collaborative study between MAPS and the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, with plasma biomarker collaboration with researchers at Stanford University. Learn more…
$400,000estimated study cost | $13,000raised$15,000raised by partners | $372,000still needed |
Donate
|
Ayahuasca Research
Survey: Ayahuasca for PTSD
We are currently accepting responses for our new anonymous questionnaire about the potential risks and benefits associated with taking ayahuasca as a therapy for posttraumatic stress disorder (PTSD). The data collection is being sponsored by MAPS, and Jessica Nielson, Ph.D., is the Principal Investigator for this study. Take the survey…
Learn more about current and upcoming research at maps.org.
Psychedelic Harm Reduction
Zendo Project: Fundraising Success, Event Updates, and More
We are proud to announce that the Zendo Project fundraising campaign raised $31,170 to support psychedelic harm reduction this year! This has been a huge year of growth and transformation for the Zendo Project. The RiverStyx Foundation matched the first $15,000 in gifts to fund the Zendo Project’s psychedelic harm reduction services at Burning Man 2016, and we exceeded our $30,000 goal. We express our sincere gratitude for our volunteers, donors, and community for their overwhelming support our work. You can still make a donation to support the expansion of our services and educational outreach programs. Donate today…
From October 13-16, 2016, the Zendo Project provided psychedelic harm reduction services at YOUtopia, the San Diego Regional Burning Man event. Twenty-five volunteers, including many joining us for the first time, offered compassionate care for 28 guests throughout the event. Zendo Project volunteers worked alongside RGX Medical staff and Rangers, and was located between Medical and DanceSafe. The event was a successful collaboration of safety services.
From November 11-13, 2016, the Zendo Project will be at Catharsis on the Mall, an event taking place in Washington, D.C. Zendo Project Director Sara Gael will be giving a talk about psychedelic harm reduction on Saturday, November 12, at 3:00 PM, and Zendo Project volunteers will be present on both nights for those feeling overwhelmed and in need of a safe space.
For the fifth consecutive year, the Zendo Project will provide psychedelic harm reduction services at Envision Festival in Costa Rica, an event taking place in February 2017. Volunteer applications for this event are now being accepted. Apply to volunteer…
Learn about psychedelic harm reduction by signing up for the Zendo Project Email Newsletter, and following the Zendo Project on Facebook, Twitter, and Instagram
MAPS Founder Rick Doblin, Ph.D., Bia Labate, Ph.D., Kenneth Tupper, Ph.D., and Alicia Danforth, Ph.D., at the Future of Psychedelic Medicine event in New York City.
Support MAPS
October Giving Report: Support for the Future of Psychedelic Medicine
In October 2016, MAPS received nearly $372,000 in new donations and pledges from 313 supporters.
In the month of October, MAPS held its annual New York City fundraising dinner, the Future of Psychedelic Medicine. This event was held in conjunction with the Horizons: Perspectives on Psychedelics conference. The dinner was graciously hosted by Giancarlo and Stephanie Canavesio and raised nearly $83,000 for MAPS’ purchase of one kilogram of GMP MDMA to be used in our final Phase 3 studies exploring MDMA-assisted psychotherapy for the treatment of PTSD. The success of this event was thanks in part to a two-for-one matching grant from Laura and Ed Littlefield, who pledged to donate $40,000 if MAPS could raise $20,000.
We witnessed some great connections and incredible generosity at the New York dinner, driven by a shared passion for the future of psychedelic medicine. We give special gratitude to our hosts, Giancarlo and Stephanie. You can read an interview with Giancarlo, co-producer of the 2013 documentary film Neurons to Nirvana, in our upcoming winter Bulletin. We also appreciate the presence of our host
committee members: Maeve Rockefeller, Jim Apteker, Susan Brody, Sheila Burgel, Darren Fortunato, Stefanie Frank, Bailey Gimbel, Neal M. Goldsmith, Ph.D., Joshua Mailman, Rodrigo Niño, Daniel Pinchbeck, Patricia Steele, and Monica Winsor.
We extend a special thanks to those who so generously supported MAPS this past month:
General Support
- Emil Arfvidsson ($3,000)
- Adam Strauss ($1,241)
- Jerry Greenfield ($1,000)
- Gary Heine ($1,000)
- Dan Mottsman ($1,000)
MDMA/PTSD Phase 3 GMP MDMA:
- Laura and Ed Littlefield ($40,000)
- Rodrigo Niño ($10,000)
- Maeve Rockefeller ($5,000)
- Kevin Herbert ($5,000)
- Giancarlo Canavesio ($1,000)
- Scott Shannon ($1,000)
- Patrick Vernon ($1,000)
- Clifford Perlman ($1,000)
MDMA/PTSD Phase 3 Therapist Training Program:
- Smart Family Foundation ($125,000)
- William H. Donner Foundation ($55,000)
MDMA/PTSD Phase 3 Research:
- Mental Insight Foundation ($50,000)
- Social Venture Partners Portland ($25,000)
MDMA/End of Life Anxiety Study:
- Mental Insight Foundation ($30,000)
Marijuana for PTSD:
- Adam Denmark Cohen ($2,500)
Zendo Project:
- Tyler Norris ($1,000)
- Connor Hill ($1,000)
MAPS relies on the generosity of individual donors to achieve our mission. Psychedelic science is again being conducted under federal guidelines, but no funding for psychedelic psychotherapy research is yet available from governments or major foundations that aren’t family foundations. Learn how to how to include MAPS in your will or estate plans. Learn more about hosting a Global Psychedelic Dinner to bring your community together in support of psychedelic science and medicine.
Media
KQED, Rolling Stone, Mad in America, and more…
FEATURED
Mad in America
Psychedelic Series #1: Over the Mountain
Meaghan Buisson | October 7, 2016
FEATURED
KQED Science
Can Ecstasy Help Relieve Social Anxiety Epidemic Among Autistic People?
April Dembosky | October 24, 2016
Rolling Stone
LSD Now: How the Psychedelic Renaissance Changed Acid
Jesse Jarnow | October 6, 2016
The Science Explorer
Your Brain on Ayahuasca: The Amazonian Hallucinogenic Plant Mixture
Kelly Tatera | October 5, 2016
Circa
MDMA by Prescription? Psychedelic Therapy Shows Promise for Treating PTSD and Addiction
Emily Faber | October 13, 2016
Psych Congress
Using Psychedelics in Psychotherapy
Andrew Penn and Saundra Jain | October 23, 2016
Ars Technica
Studying Marijuana Remains a Drag
Beth Mole | November 5, 2016 < /p>
Explore MAPS in the Media for more psychedelic and medical marijuana research news.
MAPS Store
Ayahuasca Reader: Encounters with the Amazon’s Sacred Vine
Edited by Luis Eduardo Luna and Steven F. White
Paperback | 496 pages | Synergetic Press
The new, expanded edition of Ayahuasca Reader shares many distinct voices of the global ayahuasca movement: researchers conducting clinical studies on its healing effects, painters depicting the ineffable experience with visionary images, indigenous people carrying the wisdom of ancestral traditions, and the stories of how ayahuasca has opened these individuals to their connection with the natural world and their true selves.
“An incredibly fascinating anthology of human attempts to express ineffable experiences facilitated by ayahuasca in verbal reports, scientific reflections, poems, songs and art. A rich, interdisciplinary resource for anyone intrigued by the frontiers of consciousness and its exploration.” —William A. Richards, Ph.D., Johns Hopkins School of Medicine, author of Sacred Knowledge: Psychedelics and Religious Experiences
$26.95 | Now available
NEW The Ketamine Papers: Science, Therapy, and Transformation
Edited by Phil Wolfson, M.D., and Glenn Hartelius, Ph.D.
Paperback | 448 pages | Published by MAPS
The Ketamine Papers opens the door to a broad understanding of this medicine’s growing use in psychiatry and its decades of history providing transformative personal experiences.
This comprehensive volume is the ideal introduction for patients and clinicians alike, and for anyone interested in the therapeutic and transformative healing power of this revolutionary medicine.
“The Ketamine Papers is a valuable addition to our understanding of this medicine. Wolfson and Hartelius have cultivated an all-star lineup of ketamine experts to convey all the nuances of this exciting new paradigm in psychiatric treatment.” —Julie Holland, M.D., author of Moody Bitches, Weekends at Bellevue, and Ecstasy: The Complete Guide
$24.95 | Pre-order now
Release Date: November 18, 2016
Events
Browse our Event Calendar for more upcoming events.
Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
Join us from April 19-24, 2017, in Oakland, California, for Psychedelic Science 2017, a six-day international gathering featuring three days of Conference programming, three full days of Workshops, a Sunset Cruise on the San Francisco Bay, the world’s first Psychedelic Comedy Banquet, a free and expansive Marketplace of goods and ideas, participant-led Community Sessions, and much more. Scientists, doctors, therapists, students, educators, policymakers, artists, and others from around the world will share recently completed and ongoing research into the risks and benefits of psychedelics and medical marijuana for science, medicine, spirituality, creativity, and more. Psychedelic Science 2017 is the third international Psychedelic Science conference, building on the success of Psychedelic Science in the 21st Century (2010) and Psychedelic Science 2013. Past Psychedelic Science conferences sold out early, so reserve your tickets soon. Register now for a 15% discount…
Psychedelic Science 2017 is presented by MAPS and The Beckley Foundation
“A Good Trip” Tour with Comedian Shane Mauss: November 10, 2016-January 25, 2017
Comedian Shane Mauss hosts a hilarious journey through the stigma, history, laws, and science of psychedelics in his new nationwide tour. Shane will share personal experiences and talk about the effects of psychedelics such as mushrooms, LSD, and DMT. Shane is an advocate for psychedelic studies and rights, and psychedelics are also the source of some of the most hilarious, thought-provoking, and well-received material of his career. MAPS is proud to be an honorary sponsor of “A Good Trip.” Register Now…
Catharsis on the Mall: A Vigil for Healing: November 11-13, 2016, Washington, D.C.
MAPS is a sponsor and co-organizer of the second annual Catharsis on the Mall: A Vigil for Healing, an event taking place in Washington, D.C., from November 11-13, 2016. The Zendo Project will be present on both nights for those feeling overwhelmed and in need of a safe space. Learn more…
Discovering the Way of the Psychonaut: Virtual Event
Join psychedelic research pioneer Stanislav Grof, M.D., Ph.D., for Discovering the Way of the Psychonaut, a free virtual event for people interested in learning about psychedelic research. Register….
KRIYA Institute Ketamine Conference: November 12-13, 2016, Hillsborough, CA
Researcher Phil Wolfson, M.D., will be presenting at KRIYA Ketamine Conference about ketamine-assisted psychotherapy, and also presenting his new book, forthcoming from MAPS this November and co-edited by Glenn Hartelius, Ph.D.: The Ketamine Papers: Science, Therapy, and Transformation. Learn More…
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults: November 18, 2016, San Francisco, CA
This presentation will focus first on pioneering MAPS-sponsored research into MDMA-assisted therapy for treating social anxiety in autistic adults. Scholar and author Nick Walker will present on his key role in the study and his perspective on why the study is so important. MAPS-sponsored researcher Alicia Danforth, Ph.D., will share insights on how working with diverse populations and neurodive
rgent individuals in clinical research has challenged best practice standards for set and setting in psychedelic research in general. This event is an educational program of the CIIS Center for Psychedelic Therapies and Research in collaboration with CIIS Public Programs and Performances. Register now…
Preparing for a Post-Prohibition World: The Past, Present, and Future of MDMA-Assisted Therapy: December 2, 2016, San Francisco, CA
Join MAPS Founder Rick Doblin, Ph.D., for a conversation about what inspired him to found MAPS in 1986, the current state of MAPS’ drug development plan for MDMA-assisted psychotherapy for PTSD, and the future of psychedelic-assisted therapy. This event is an educational program of the CIIS Center for Psychedelic Therapies and Research in collaboration with CIIS Public Programs and Performances. Register now…
More News
MAPS Public Benefit Corporation (MPBC) is Hiring
MAPS Public Benefit Corporation (MPBC), a wholly owned subsidiary of MAPS, is currently hiring a Clinical Operations Associate (COA) to work from our office in Santa Cruz, Calif., and support the MPBC clinical research team. The candidate should be comfortable working in a small but fast paced environment while maintaining a positive outlook and attention to detail. The successful candidate will have strong analytical competencies, as well as knowledge in clinical development. The COA is responsible for supporting the Clinical Teams and Clinical Research Sites interactions with Accounting. Learn more….
The Shulgin Archive Launches Crowdfunding Campaign
The Shulgin Archive is dedicated to creating a global-access digital library of psychedelic research pioneer Alexander “Sasha” Shulgin and his wife Ann Shulgin’s extensive documentation of their research on psychedelics to support the ongoing efforts of psychotherapists, researchers, and social activists interested developing a foundation for therapeutic psychedelic use in society. Learn more…
CIIS Certificate Program Opens Enrollment
The California Institute of Integral Studies (CIIS) is enrolling applicants for the Psychedelic-Assisted Therapies and Research Certificate program taking place in San Francisco, Calif. Learn more…
Journal of Psychedelic Studies Accepting Manuscript Submissions
The Journal of Psychedelic Studies is currently accepting manuscript submissions for upcoming publications. The journal seeks to provide an interdisciplinary forum for the exchange of information about psychedelic substances and the biological, neurochemical and psychological changes they facilitate, as well as their social implications. Learn more…