FDA Comments on Special Protocol Assessment for Phase 3 Trials of MDMA-Assisted Therapy for PTSD
The Zendo Project provides psychedelic peer support for over 260 guests at Lightning in a Bottle
June 16, 2017
Dear friends and supporters,
This is MAPS’ most important summer in our 31-year history. Through our collaboration with the U.S. Food and Drug Administration (FDA), we are nearing the completion of the Special Protocol Assessment (SPA) process for our Phase 3 trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). In addition, FDA will be reviewing our application for Breakthrough Therapy designation for MDMA-assisted psychotherapy for PTSD.
The results from our two ibogaine observational studies have now been published in the American Journal of Drug and Alcohol Abuse, highlighting how the therapeutic use of ibogaine can be helpful in the treatment of opioid addiction.
For the fourth consecutive year, the Zendo Project collaborated with the Lightning in a Bottle festival to provide psychedelic peer support and harm reduction education for attendees. During the five-day event, Zendo Project staff and volunteers assisted over 260 guests across two locations.
In the June 2017 edition of the MAPS Email Newsletter, you’ll also learn:
- The DEA conducts a formal inspection of the study site at Emory University for our upcoming Phase 1 study on the effect of MDMA on startle testing.
- Four more participants receive marijuana in our ongoing clinical trial of smoked marijuana for PTSD in U.S. veterans.
- Our MDMA therapy training study enrolls one new participant
- The MAPS Store now includes The Manual of Psychedelic Support.
Your support makes our mission possible.
MAPS Associate Director of Communications and Marketing
Psychedelic Science 2017 is highlighted in a new short documentary film produced by Cinematic Syndicate.
Treating PTSD with MDMA-Assisted Therapy
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Treating PTSD with MDMA-Assisted Therapy
FDA Comments on Special Protocol Assessment (SPA) for Phase 3 Trials of MDMA-Assisted Therapy for PTSD
On June 13, as part of FDA’s Special Protocol Assessment process, MAPS submitted to FDA a revised Phase 3 protocol evaluating MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The protocol was revised based on discussions between MAPS and FDA during our May 11, 2017 Type A meeting and on FDA’s official meeting minutes we received on May 30, 2017. Based on the agreements reached during the May 11 Type A meeting we’re hopeful this will be our final revision.
Donations are currently being sought to reach MAPS’ goal of raising $25 million, with $10 million already raised, to successfully execute the Phase 3 studies required to gain approval from FDA for MDMA-assisted psychotherapy by 2021. Learn more…
Therapist Training Study: One New Participant Enrolls
On June 9, 2017, the 30th of 100 participants enrolled in our ongoing Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. 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. The new participants were enrolled at the Boulder, Colorado, study site led by Principal Investigator Marcela Ot’alora, M.A., L.P.C. Michael Mithoefer, M.D., is serving as Principal Investigator at the site in Charleston, South Carolina with Sub-Investigator Ann Mithoefer, B.S.N. Learn more…
Startle Testing with MDMA: DEA Completes Site Inspection
On June 5, 2017, the U.S. Drug Enforcement Administration (DEA) conducted a formal inspection of the study site at Emory University for our upcoming Phase 1 study on the effect of MDMA on startle testing in healthy volunteers. Principal Investigator Barbara Rothbaum, Ph.D., a leading PTSD researcher, will conduct the MAPS-sponsored study at Emory University in Atlanta, Georgia. The study will begin after DEA approval. This study will be followed by one exploring the combination of MDMA with Prolonged Exposure in PTSD patients. Learn more…
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: 18th and Final Participant Completes Treatment
On May 1, 2017, the 18th and final participant received their last experimental treatment in our ongoing Marin, Calif., study of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness. 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 associated with a diagnosis of a life-threatening illness. Learn more…
Four New Participants Enroll in Smoked Marijuana Trial for Chronic PTSD in Veterans
As of June 1, 2017, a total of 18 of 76 participants have enrolled and received study drug in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. Four new participants have enrolled since May 4, and participant screening is ongoing. Taking place at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, this clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans. Learn more…
Survey: Ayahuasca for PTSD
We are accepting responses for our anonymous questionnaire about the potential risks and benefits associated with using ayahuasca as a therapy for posttraumatic stress disorder (PTSD). The data collection is being sponsored by MAPS, with Jessica Nielson, Ph.D., as the Principal Investigator for this study. Take the survey…
Two New MAPS-Sponsored Studies Show Ibogaine’s Promise As Treatment for Opioid Addiction
The promising results of two MAPS-sponsored observational studies into treating opioid dependence with ibogaine, a naturally occurring psychedelic compound, have been published in the peer-reviewed American Journal of Drug and Alcohol Abuse. Both studies show that ibogaine should be further studied as a potential treatment for opioid dependence through rigorously controlled studies. Read the Press Release…
Learn more about current and upcoming research at maps.org.
Psychedelic Peer Support Provided for Over 260 Attendees at Lightning in a Bottle
From May 24-29, 2017, 70 Zendo Project staff and volunteers returned to the Lightning in a Bottle festival in Bradley, Calif., and provided psychedelic peer support for over 260 attendees. For the first time at the event, the Zendo Project created safe spaces in two separate locations across the festival, allowing a more comprehensive approach for harm reduction services. The Zendo Project worked alongside medical staff (RGX Medical), DanceSafe, Lightning in a Bottle Rangers, and High Rock Security to help maintain a safe environment for attendees.
On May 25, Zendo Project Director Sara Gael, Zendo Project Manager Ryan Beauregard, and Zendo Project Logistics Coordinator Erica Siegal led a public training on the principles of psychedelic peer counseling, including techniques, volunteer self-care, and integration support. In addition to the 2-hour training, the Zendo Project also hosted an intention setting circle and an hour-long participation-based workshop.
Over the course of the five-day event, the Zendo Project’s trained volunteers donated approximately 1,800 hours to provide compassionate care and peer-to-peer support for individuals having a difficult psychedelic experience or needing other psychological support. These services are part of our effort to further develop community engagement, education, and awareness about psychedelic experiences and harm reduction.Apply to volunteer…
May Giving Report: End of the Fiscal Year
In May 2017, MAPS raised $499,646 in new donations and pledges from 310 supporters. May 31 marked the end of the Fiscal Year.
On June 6, soon after the start of the new Fiscal Year, MAPS received a $1 million check from Dr. Bronner’s. This is their first gift in fulfilling their five-year $5 million pledge made last month during the Psychedelic Science 2017 conference.
MAPS is moving forward with its research on MDMA-assisted psychotherapy for the treatment of PTSD. Phase 3 studies will cost between $25-$35 million for both FDA and European Medicines Agency (EMA) approval. With $10 million in hand, there’s still a funding gap we need to close.
We extend a special thanks to those who so generously supported MAPS last month:
- Scorpio Rising Fund ($250,000)
- George Goldsmith & Katya Malievskaia ($25,000)
- Carey & Claudia Turnbull ($25,000)
- Jeffrey C. Crawford ($5,000)
- Nori Muster ($3,100)
- Paul & Emily Eastham ($3,000)
- Anonymous ($2,000)
- AmazonSmile Foundation ($1,810)
- Matthew London & Sylvia Wen ($1,000)
- Paul Kuhn, Jr. ($1,000)
MDMA/PTSD Phase 3 Studies
- Andrew Mason ($42,050)
- John Gilmore ($10,000)
- Naguib Sawiris ($5,000)
- The Thomas P. Waters Foundation ($3,000)
- Darius Contractor ($1,500)
- Britt Selvitelle ($1,000)
- Justin Rosenstein ($1,000)
- Hilary Silver ($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.
Help make MDMA a medicine by 2021 by starting a monthly gift of $10 or more. maps.org/donate
CBS Bay Area, Comedy Central, Playboy, and more…
CBS San Francisco Bay Area
Psychedelic Science 2017: Collector’s Tumbler
These gorgeous hand-crafted, limited edition mugs are a beautiful reminder of the community that came together to share research findings and celebrate at Psychedelic Science 2017, the world’s largest conference ever on psychedelic research. Each mug is individually numbered (X out of 500) and features the MAPS, Beckley Foundation, and Psychedelic Science 2017 logos, and signatures from Rick Doblin and Amanda Feilding. Measuring approximately 7 inches high and 3.5 inches in diameter. These were created with love by artist Ipek Kotan.
$30.00 | Purchase today
Psychedelic Science 2017: Shirt
Show your support for Psychedelic Science with this soft, V-neck shirt! They are lightweight and durable with a casual, yet professional look. Made from 65% polyester and 35% combed ring-spun cotton, in the USA by Next Level Apparel, and screen printed locally in Santa Cruz, by The Print Gallery.
$30.00 | Purchase today
The Manual of Psychedelic Support
The Manual of Psychedelic Support is a new harm reduction resource providing a comprehensive overview of how people can provide compassionate care to people undergoing difficult psychedelic experiences during large-scale music festivals and events.
$25.95 | Purchase today
Browse our Event Calendar for more upcoming events.
A Good Trip with Shane Mauss (USA
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.” Learn more…
Breaking Convention: June 30 – July 2, 2017, London, England
Breaking Convention is a biennial multidisciplinary conference on psychedelic consciousness, featuring more than 150 presenters from around the world. One of the biggest psychedelic meetings in the world, the conference features more than a dozen interactive workshops, a visionary art exhibition, installation gallery, psychedelic film festival, theatre and performance programme, evening banquet, and celebrations every night at the SU bar. Learn more…
International Transpersonal Conference: September 28 – October 1, 2017, Prague, Czech Republic
The mission of the conference is to present an exclusive series of lectures, panel discussions and experiential workshops delivered by legendary founders of transpersonal psychology and key figures of the current transpersonal movement, as well as by young and progressive adepts. Our aim is to facilitate a major gathering of scholars, researchers, practitioners, supporters and all other kinds of people interested in transpersonal movement and new paradigm sciences.
We would like to honor and celebrate 50 years of the existence of transpersonal psychology as well as to follow the tradition of large international transpersonal conferences of the past. After exactly 25 years from the first and highly successful conference at “the heart of Europe”, we are again calling a transpersonal assembly in our beautiful and “magic” city Prague, famous for its important role in the history of spirituality, alchemy and science. Learn more…
Horizons: Perspectives on Psychedelics: October 7 – 9, 2017, 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. In recent years, a growing community of scientists, doctors, artists, activists, seekers and scholars have orchestrated a renaissance in psychedelic thought and practice. Horizons brings together the brightest minds and the boldest voices of this movement to share their research, insights, and dreams for the future. Learn more…
International Drug Policy Reform Conference: October 11 – 14, 2017, Atlanta, GA
The International Drug Policy Reform Conference is a biennial event that brings together people from around the world who believe that the war on drugs is doing more harm than good. This year attendees will have the opportunity to spend three days interacting with people committed to finding alternatives to the war on drugs while participating in sessions given by leading experts from around the world. Don’t miss the opportunity to be a part of this event. Learn more…
Entheogenesis Australis Outdoor Psychedelic Symposium: December 8 – 10, 2017, Australia
We are excited to officially announce Australia’s premier psychedelic symposium Entheogenesis Australis (EGA) 2017. The 2017 EGA Outdoor Psychedelic Symposium (Retreat) is set to unfold on a beautiful bushland property 2 hours drive east of CBD Melbourne Australia. The event will cover a diverse range of fields from the botanical, academic, and philosophical, to arts and drug law reform. Learn more…
Global Psychedelic Dinners
By hosting your own Global Psychedelic Dinner, you’ll join people around the world in gathering your community, having an open conversation about psychedelics, and raising funds to support MAPS. Host a dinner…