FDA Grants Request for End of Phase 2 Meeting This November
Zendo Project psychedelic harm reduction service assists 180 attendees at Symbiosis Festival
October 5, 2016
Dear friends and supporters,
This week, we reached an important milestone in our work to make MDMA-assisted psychotherapy an approved treatment for posttraumatic stress disorder (PTSD). On October 3, the U.S. Food and Drug Administration (FDA) granted our request for an End of Phase 2 meeting to agree on the design of our upcoming Phase 3 trials, the final stage of research required to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD. The meeting is scheduled for November 29, and Phase 3 trials expected to begin early next year.
MAPS’ Phase 3 clinical trials will require many new researchers trained in the principles and practice of MDMA-assisted psychotherapy for PTSD. Last month, 31 therapists in training to be Phase 3 researchers participated in the MAPS Therapist Training Program (pictured above). Additional participants were also treated in our ongoing therapist training study in preparation for Phase 3.
In the October 2016 edition of the MAPS Email Newsletter, you’ll also learn:
- The first pair of participants receive their second experimental treatment in our new study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD
- The 11th participant is treated in our ongoing trial of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness
- The 12th participant is enrolled in our ongoing study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum
- Participant screening begins at the Phoenix, Ariz., site of our upcoming trial of smoked marijuana for symptoms of PTSD in U.S. veterans
Spread the word and stay connected by following us on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.
Do you want to present your research at Psychedelic Science 2017? Abstracts are due November 1. Also, get 15% off registration for Psychedelic Science 2017 until November 15.
There have never been so many opportunities for scientific research into the therapeutic benefits of psychedelics and marijuana-and that means your support is more important than ever. Find out how you can help.
With excitement and dedication,
Brad Burge
MAPS Director of Communications and Marketing
P.S. Last month, the Zendo Project provided psychedelic harm reduction services at Symbiosis Festival in California, with 62 volunteers and 180 guests.
Contents
Treating PTSD with MDMA-Assisted Therapy
1 Phase 3 Trials: FDA Grants Request for End of Phase 2 Meeting
2 Therapist Training Program: Group Training Takes Place in Los Angeles
3 Therapist Training Study: Participants Enrolled in Colorado and South Carolina
4 Conjoint Therapy for PTSD: First Pair of Participants Complete Active Treatment
5 Boulder: 19th Participant Completes Long-Term Follow-Up Interview
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
6 Marin: 11th Participant Treated; 12th Participant Enrolled
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
7 Social Anxiety in Autistic Adults: 12th and Final Participant Enrolled
Medical Marijuana
8 Marijuana for PTSD: Participant Screening Begins in Phoenix, Arizona
Ayahuasca Research
9 Ayahuasca for PTSD: Survey Update
Psychedelic Harm Reduction
10 Zendo Project: Symbiosis Gathering Integrates Psychedelic Harm Reduction
Support MAPS
11 September Giving Report: From Clinical Research to Harm Reduction, You Make Our Work Possible
Media
12 The Guardian, VolteFace, The Verge, and more…
MAPS Store
14 Manifesting Minds: A Review of Psychedelics in Science, Medicine, Sex, and Spirituality
Events
15 Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
16 “A Good Trip” Tour with Comedian Shane Mauss: October 5, 2016-January 25, 2017
17 Horizons: Perspectives on Psychedelics: October 7-9, 2016, New York, NY
18 Psychedelic Stories with Duncan Trussell & Friends: October 8, 2016, Brooklyn, NY
19 The Research Frontier: Entheogens and Empathogens: October 9, 2016, New York, NY
20 Psychedelic Psychotherapy Forum: October 14-15, 2016, Victoria, BC
21 World Ayahuasca Conference: October 17-22, 2016, Rio Branco, Brazil
22 Science and Non-Duality (SAND) Gathering: October 19-23, 2016, San Jose, CA
Researchers prepare the marijuana before subject screening begins at our study site in Phoenix, Ariz.
Treating PTSD with MDMA-Assisted Therapy
Phase 3 Trials: FDA Grants Request for End of Phase 2 Meeting
On October 3, 2016, the U.S. Food and Drug Administration (FDA) granted our request for an End of Phase 2 Meeting, with the meeting scheduled for November 29, 2016. The goal of this meeting will be to come to an agreement on the design of our upcoming Phase 3 trials, the final stage of research required to make MDMA-assisted psychotherapy a legal prescription treatment for PTSD. Staff and researchers at MAPS and the MAPS Public Benefit Corporation (MPBC) will travel to the FDA’s White Oak Campus in Silver Spring, Maryland, for a 90-minute meeting to review the promising data from our six completed Phase 2 studies, and to decide on an efficient and scientifically rigorous design for our Phase 3 trials, which we anticipate starting in 2017. “We will receive the FDA’s questions on our End of Phase 2 submission package just two days before the meeting, giving our team very little time to prepare our responses for the meeting,” says MPBC Executive Director Amy Emerson. “It’s both challenging and exciting, since after the meeting we’ll have clear direction on the design of our Phase 3 trials.” Learn more…
Therapist Training Program: Group Training Takes Place in Los Angeles
From September 19-25, 2016, 30 trainees participated in Part B of the MAPS Therapist Training Program in the principles and practice of MDMA-assisted psychotherapy for PTSD. The training program is currently focused on preparing researchers for a position in upcoming MAPS-sponsored Phase 3 trials. Led by MAPS-sponsored researchers Michael Mithoefer, M.D., Annie Mithoefer, B.S.N., and Marcela Ot’alora, M.A., L.P.C., in Los Angeles, Calif., trainees learned the techniques of MDMA-assisted psychotherapy as outlined in the Treatment Manual, watched videos of therapy sessions from Phase 2 trials, and dialogued with other therapists in training about the therapeutic approach. MAPS’ five-part training program includes two in-person trainings, and is required for co-therapists who will be working on MAPS’ Phase 3 trials of MDMA-assisted psychotherapy PTSD, which are planned to start in 2017. Additional trainings will be provided in October 2016, and January 2017 to accommodate researchers preparing for Phase 3 trials. If you are interested in receiving updates in the future when external trainings become available, please sign up on our website. Learn more…
Therapist Training Study: Participants Treated in Colorado and South Carolina
On September 28, 2016, the 14th participant was enrolled in our ongoing Phase 1 study of the psychological effects of MDMA when taken in a therapeutic setting by healthy volunteers in Charleston, South Carolina. The Charleston site is led by Michael Mithoefer, M.D. On September 26 and September 28, 2016, the first and second participants were enrolled and treated 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. Learn more…
| $200,000estimated study cost | $165,000raised | $35,000still needed |
Donate Nowhelp fund more research |
Conjoint Therapy for PTSD: First Pair of Participants Receive Second Treatment
On August 23, 2016, the first pair of participants received their second experimental treatment in our new study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD in Charleston, South Carolina. Final outcome measures for this pair (dyad) will be collected during the one-month follow-up taking place on October 9, 2016. The study will enroll 10 dyads, with one participant diagnosed with PTSD and one concerned significant other who does not have PTSD but does experience psychosocial distress. The primary goal of this study is to develop a combined method of MDMA with CBCT for PTSD. MDMA will be administered to both participants to help facilitate communication and connection between participants and therapists. We are currently screening additional local participants for this study. Learn more…
| $200,000estimated study cost | $165,000raised | $35,000still needed |
Donate Nowhelp fund more research |
Boulder: 19th Participant Completes Long-Term Follow-Up Interview
On October 3, 2016, the 19th participant completed their long-term (12-month) follow-up interview in our Phase 2 study of MDMA-assisted psychotherapy for 23 subjects with chronic, treatment-resistant PTSD in Boulder, Colorado. Long-term follow-up 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 |
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: 11th Participant Treated; 12th Participant Enrolled
On September 15, 2016, the 11th participant was treated in our ongoing study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness in Marin, Calif. On August 26, 2016, the 12th participant was officially enrolled. Led by Principal Investigator Phil Wolfson, M.D., with co-therapist Julane Andries, LMFT, 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: 12th and Final Participant Enrolled
On September 13, 2016, the 12th and final participant was enrolled in our ongoing study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum. A generous donation in support of this study has allowed us to add this final participant. Sponsored by MAPS, this is a collaborative study between MAPS and the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, with blood plasma biomarker analysis conducted by researchers at Stanford University. MAPS-sponsored researcher Alicia Danforth, Ph.D., will present preliminary results from this study on October 8, 2016, at Horizons: Perspectives on Psychedelics in New York City. Learn more…
| $400,000estimated study cost | $13,000raised$15,000raised by partners | $372,000still needed |
Donate Nowhelp fund more research |
Medical Marijuana
Trial participants will use small pipes to self-administer
marijuana as needed for PTSD symptoms.
Marijuana for PTSD: Participant Screening Begins in Phoenix, Arizona
On October 3, 2016, researchers at the Phoenix, Ariz., site of our upcoming trial of smoked marijuana for symptoms of PTSD in U.S. veterans began screening participants. On September 29, the Phoenix site received the final delivery of study supplies, including the pipes that participants will use for self-administering marijuana. Former Clinical Research Associate Ben Shechet of MAPS Public Benefit Corporation (MPBC) has transitioned his role to become the new Study Coordinator for our study site in Phoenix. Learn more…
Ayahuasca Research
As of September 29, 2016, we have received 153 completed 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. “Preliminary trends indicate reductions in PTSD symptoms, depression, suicidal thoughts, and alcohol and prescription drug use,” reports Nielson. Take the survey…
Psychedelic Harm Reduction
The Zendo Project provided psychedelic harm reduction services at Symbiosis Gathering in Oakdale, Calif.
Zendo Project: Symbiosis Gathering Integrates Psychedelic Harm Reduction
Over $30,000 already raised from 130+ supporters!
From September 22-26, 2016, the Zendo Project provided psychedelic harm reduction services at Symbiosis Gathering in Oakdale, Calif. A total of 62 volunteers donated their time and energy to the project, and we were able to assist 180 guests throughout the weekend. We thank Symbiosis, our volunteers, and all of our guests for showing up to do this important work.
The RiverStyx Foundation matched the first $15,000 in gifts to fund the Zendo Project’s psychedelic harm reduction services provided at Burning Man 2016, and we have now met our $30,000 goal!
Learn about psychedelic harm reduction by signing up for the Zendo Project Email Newsletter, and following the Zendo Project on Facebook, Twitter, and Instagram
Support MAPS
September Giving Report: From Clinical Research to Harm Reduction, You Make Our Work Possible
In September 2016, MAPS received nearly $30,000 in new donations from 245 supporters. We’ve met our $30,000 goal to expand the Zendo Project’s services at Burning Man, thanks to the $15,000 matching grant from the Riverstyx Fou
ndation. You can still make a donation to the Zendo Project now!
We extend a special thanks to those who so generously supported MAPS this past month:
General Support
- TinMan Fund ($15,000)
MDMA/PTSD Study, Vancouver, BC Canada
- Scott Shannon ($1,200)
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. 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.
The Summer 2016 Research Edition of the MAPS Bulletin is now available online, featuring original articles from MDMA-assisted psychotherapy study participants, psychedelic harm reduction volunteers, and more.
Media
The Guardian, VolteFace, The Verge, and more…
FEATURED
The Guardian
‘My Therapist Gave Me a Pill’: Can MDMA Help Cure Trauma?
Olivia Solon | September 16, 2016
VolteFace
Legitimising MDMA, ‘The Love Drug’, For Couples Therapy
Rosalind Stone | September 20, 2016
The Verge
Why Banning the Opiate-Like Plant Kratom Might Do More Harm Than Good
Alessandra Potenza | September 22, 2016
Stars and Stripes
Can Marijuana Improve PTSD Symptoms for Veterans?
Matthew M. Burke | September 5, 2016
Float Conference
Float Conference 2016: Rick Doblin
September 19, 2016
The Cognitive Rampage
Adam Lowery | September 6, 2016
Here We Are with Shane Mauss
Here We Are Podcast with Berra Yazar-Klosinski + Amy Emerson
Shane Mauss | September 12, 2016
Explore MAPS in the Media for more psychedelic and medical marijuana research news.
MAPS Store
MAPS Hooded Fleece
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Stay warm and show your support for MAPS in this stylish and extremely soft hooded fleece.
Made in the USA and screen-printed by hand in Santa Cruz, Calif., by local artist Clay Chollar. Available in limited sizes and quantities.
$60.00 | Now available
Manifesting Minds: A Review of Psychedelics in Science, Medicine, Sex, and Spirituality
Edited by Rick Doblin, Ph.D., and Brad Burge
Paperback | 304 pages | North Atlantic Books (2014)
| |
Featuring essays and interviews with Timothy Leary, Aldous Huxley, Ram Dass, Albert Hofmann, Alexander (Sasha) Shulgin, Daniel Pinchbeck, Tim Robbins, Arne Naess, and electronic musician Simon Posford, as well as groundbreaking research and personal accounts, this one-of-a-kind anthology is a “best of” collection of articles and essays published by the Multidisciplinary Association for Psychedelic Studies (MAPS).
This book is 25% off during the month of October.
$19.95 $14.96 | Now available
Events
Explore our Event Calendar for more events. Do you have an event you’d like to share? Please send event suggestions to askmaps@maps.org.
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. View the Call for Papers | Register now….
Psychedelic Science 2017 is presented by MAPS and The Beckley Foundation
“A Good Trip” Tour with Comedian Shane Mauss: October 5, 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…
Horizons: Perspectives on Psychedelics: October 7-9, 2016, New York, NY
Horizons: Perspectives on Psychedelics is an annual forum in New York City that examines the role of psychedelic drugs in science, healing, culture and spirituality. Horizons brings together the brightest minds and the boldest voices of this movement to share their research, insights, and dreams
for the future. Speakers include MAPS founder Rick Doblin, Ph.D., MDMA researcher Alicia Danforth, Ph.D., MAPS Policy and Advocacy Manager Natalie Ginsberg, ayahuasca researcher Bia Labate, Ph.D., MDMA and PTSD researcher Michael Mithoefer, M.D., U.S. Army Brigadier General (Ret.) Loree Sutton, M.D., and many more. MAPS is a proud partner of Horizons 2016. Register…
Psychedelic Stories with Duncan Trussell & Friends: October 8, 2016, Brooklyn, NY
Join MAPS in New York City on Saturday, October 8, 2016, for Psychedelic Stories with Duncan Trussell & Friends, a benefit afterparty taking place during Horizons: Perspectives on Psychedelics 2016. The event is hosted by Psymposia, and will feature stories from MAPS Founder Rick Doblin, Ph.D., comedians, researchers, and artists. Register….
The Research Frontier: Entheogens and Empathogens: October 9, 2016, New York, NY
Following the last day of events at the Horizons: Perspectives on Psychedelics conference, Brad Burge of MAPS will moderate a lively conversation with leading experts on psychedelic medical research. This event will gather psychedelic researchers Rick Doblin, Ph.D., Dr. Julie Holland, Jeremy Wolff, Bia Labate, Ph.D., and Fabian Piorkowsky for a discussion about psilocybin, ayahuasca, MDMA, and cannabis as they relate to relationships, communication, empathy, connection and communion. Register…
Psychedelic Psychotherapy Forum: October 14-15, 2016, Victoria, BC
MAPS Founder and Executive Director Rick Doblin, Ph.D., will give the keynote address at this year’s forum. Highlighted topics will include the current state of MDMA research for alleviating PTSD; ayahuasca therapy to treat eating disorders; psilocybin studies and their implications for cancer patients and end-of-life issues; training possibilities for psychedelic psychotherapists; and how to support clients in successfully integrating the psychedelic experience. Register… | Watch the live stream…
World Ayahuasca Conference: October 17-22, 2016, Rio Branco, Brazil
MAPS is a proud co-sponsor of the 2016 World Ayahuasca Conference. Two years after the first World Ayahuasca Conference, held in Ibiza, Spain, the international ayahuasca community will come together in the spirit of the dialogue and exchange of knowledge and experience initiated in the first edition. In times of a rapid globalization of the use of ayahuasca, the dialogue about cultural recognition and protection of traditional practices worldwide is more important than ever. Register…
Science and Non-Duality (SAND) Gathering: October 19-23, 2016, San Jose, CA
MAPS is a proud partner of the 2016 Science and Nonduality (SAND) Gathering, which provides a forum where preeminent scientists, philosophers, teachers, artists, and the international community gather to explore and advance the new paradigm emerging in spirituality, that is both grounded in cutting-edge science and consistent with the ancient wisdom of Nonduality—the deep understanding of the interconnectedness of life. This year’s theme is “On the Edge of the Unknown.” MAPS researcher Ben Shechet will facilitate a community discussion on “Psychedelics: Tools for Exploration & Well-Being.” Learn more and register…