FDA and MAPS Agree on Protocol for Phase 3 Trials of MDMA-Assisted Therapy for PTSD
Over 100 videos from Psychedelic Science 2017 are now online
May 17, 2017
Dear friends and supporters,
Psychedelic Science 2017 was truly amazing. Thank you to everyone who attended or helped make possible the largest psychedelic conference in history, with over 3,000 people from 40+ countries coming together for a whirlwind six days of learning, discovery, exploration, and community-building. The New York Times called it “America’s premiere psychedelics conference”; New York Magazine called it “the psychedelics state of the union.” Plus, there’s always more to explore— over 100 videos are now available online free!
After such an inspiring gathering, we are even more motivated and working with the U.S. Food and Drug Administration to launch the first MAPS-sponsored Phase 3 trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD)—with over a dozen sites across North America and Israel. In addition to protocol discussions with the FDA, we are continuing to prepare researchers through our MDMA Therapy Training Program and our recent Investigator’s Meeting at Psychedelic Science 2017.
The Zendo Project is getting ready for a busy summer providing psychedelic harm reduction at festivals. Stay tuned for our upcoming crowdfunding campaign to learn how you can help the Zendo Project keep festival attendees safer this season.
In the May 2017 edition of the MAPS Email Newsletter, you’ll also learn:
- MAPS receives a response from the FDA as part of the Special Protocol Assessment (SPA) for our Phase 3 trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD)
- The The first pair of participants completes their six-month follow-up interview in our ongoing study of MDMA and Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD
- Three more participants receive marijuana in our ongoing clinical trial of smoked marijuana for PTSD in U.S. veterans
- Our MDMA therapy training study enrolls two more participants
Join the momentum — connect with MAPS on Facebook, Twitter, YouTube, reddit, Tumblr, Pinterest, Google+, LinkedIn, and Instagram.
Always upwards,
Brad Burge
MAPS Director of Communications and Marketing
Psychedelic Science 2017 is highlighted in a new short documentary film produced by Cinematic Syndicate.
Contents
Psychedelic Science 2017: A Moment in History
Treating PTSD with MDMA-Assisted Therapy
FDA and MAPS Agree on Protocol for Phase 3 Trials of MDMA-Assisted Therapy for PTSD
Therapist Training Study: Three New Participants Enrolled
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
Social Anxiety in Autistic Adults: Final Participant Completes Study
Medical Marijuana
7 New Participants Enroll in Smoked Marijuana Trial for Chronic PTSD in Veterans
Ayahuasca Research
Support MAPS
April Giving Report: Dr. Bronner’s Steps Up with $5 Million for Phase 3
MAPS Store
Psychedelic Science 2017: Collector’s Tumbler
The Manual of Psychedelic Support (Pre-Sale)
Events
Breaking Convention: June 30 – July 2, 2017, London, England
International Transpersonal Conference: September 28 – October 1, 2017, Prague, Czech Republic
Horizons: Perspectives on Psychedelics: October 7 – 9, 2017, New York, NY
International Drug Policy Reform Conference: October 11 – 14, 2017, Atlanta, GA
Entheogenesis Australis Outdoor Psychedelic Symposium: December 8 – 10, 2017, Australia
Researchers meet at Psychedelic Science 2017 in Oakland, California on April 24, 2017.
Treating PTSD with MDMA-Assisted Therapy
FDA and MAPS Agree on Protocol for Phase 3 Trials of MDMA-Assisted Therapy for PTSD
On May 11, 2017 MAPS and MPBC staff held a Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the upcoming Phase 3 clinical trial of MDMA-assisted psychotherapy for PTSD. At the meeting, all of the FDA’s concerns were addressed and no outstanding questions remain.
There are no road blocks to moving forward with Phase 3 as the FDA gave favorable feedback to MAPS and MPBC’s responses to FDA questions. With this collaborative meeting, we will be able to move forward with re-submitting the protocol and our Statistical Analysis Plan, the next step in the Special Protocol Assessment process. MAPS’ submission will go to FDA after it sends us official minutes of the May 11 teleconference by mid-June.
The review period after the next submission will be a month and a half. MAPS and MPBC staff are optimistic and excited to reach this milestone toward bringing healing to those diagnosed with PTSD through MDMA-assisted Psychotherapy. 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: Three New Participants Enrolled
On April 12, April 26, and May 5, 2017, the 27th, 28th, and 29th participants were enrolled in our ongoing Phase 1 study of the psychological effects of MDMA when used in a therapeutic setting by healthy volunteers. The new participant was 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. 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 26 out of 100 participants across the study sites in Colorado and South Carolina. Learn more…
| $429,000 estimated study cost | $160,000 raised | $269,000 still needed |
Donate Now |
MDMA-Assisted Therapy for Social Anxiety in Autistic Adults
Social Anxiety in Autistic Adults: Final Participant Completes Study
On April 28, 2017, the 12th and final participant completed the final follow-up visit and unblinding 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…
Medical Marijuana
7 New Participants Enroll in Smoked Marijuana Trial for Chronic PTSD in Veterans
As of May 4, 2017, a total of 14 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. Seven new participants have enrolled since April 10, 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…
Ayahuasca Research
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…
Learn more about current and upcoming research at maps.org.
Support MAPS
April Giving Report: Dr. Bronner’s Steps Up with $5 Million for Phase 3
In April 2017, MAPS co-hosted with Beckley Foundation the Psychedelic Science 2017 conference in Oakland, California. The conference was a gathering of thousands of scientists and experts sharing the newest findings in scientific and medical research investigating psychedelics and marijuana.
During Psychedelic Science 2017, David Bronner, CEO of Dr. Bronner’s, stepped up with a $5 million pledge to support MAPS’ efforts, after receiving the green light from the U.S. Food and Drug Administration (FDA) to move onto Phase 3 studies of MDMA-assisted psychotherapy for the treatment of PTSD. Over the next five years, Dr. Bronner’s will generously donate $1 million per year. David Bronner has been a trailblazer in drug policy in his own right, and it is with gratitude that MAPS accepts his incredible leadership towards legalization of MDMA as a medicine.
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.
An additional $197,000 in new donations and pledges were received from 268 supporters last month. We extend a special thanks to those who so generously supported MAPS in April:
General Support
- Jason Dorsett ($2,000)
- Ofir Kedar ($1,000)
MDMA/PTSD Phase 3 Studies
- Anja Saunders ($1,000)
- Dr. Bronner’s ($5 million)
- Rodrigo Nino ($100,000)
- Anonymous ($40,000)
- Social Venture Partners Portland ($12,500)
- Jud Ireland ($10,000)
- Daniel McMurtrie ($10,000)
- Allan M. Badiner ($1,000)
- Bertram Meyer ($1,000)
- Magaly Mauer ($1,000)
MDMA/PTSD Phase 3 GMP MDMA
- Hilary Silver ($10,000)
- Leander Fortmann ($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
Learn how to include MAPS in your will or estate plans.
Learn more about hosting a Global Psychedelic Dinner to fundraise for MAPS.
MAPS Store
Psychedelic Science 2017: Collector’s Tumbler
These gorgeous hand-crafted mugs are a beautiful reminder of the researchers who came together to share their studies and celebrate at Psychedelic Science 2017. Each one features the MAPS, Beckley Foundation, and Psychedelic Science 2017 logos. Measuring approximately 7 inches high and 3.5 inches in diameter. These were created with love by artist Ipek Kotan.
$30.00 | Purchase today
The Manual of Psychedelic Support (Pre-Sale)
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
Events
Browse our Event Calendar for more upcoming events.
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…