FDA Responds to Special Protocol Assessment for Phase 3 Clinical Trials
Psychedelic Science 2017 conference tickets are now sold out
April 15, 2017
Dear friends and supporters,
Psychedelic Science 2017 is just three days away! We’re immensely excited to welcome over 2,800 attendees from over 40 countries for what will be the largest-ever gathering focused on psychedelic science, medicine, spirituality, and creativity.
Conference tickets are now sold out, but there are still many ways you can participate! Join us in the free Marketplace from April 21-23, spend the evening with us at the free Celebrations on April 21 and April 22, or come dance at the Integration After-Party on April 23. You can also watch the entire conference online free shortly after the event on YouTube.
Meanwhile, we’re making great progress towards launching our Phase 3 trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) later this year. From ongoing discussions with the U.S. Food and Drug Administration (FDA) to continued therapist training, our clinical research team is hard at work preparing to initiate Phase 3 trials this autumn.
In the April 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 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
- Psychedelic Science 2017 researchers describe their work in a new article series on Chacruna.net
MAPS Director of Communications and Marketing
Treating PTSD with MDMA-Assisted Therapy
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Treating PTSD with MDMA-Assisted Therapy
FDA Responds About Special Protocol Assessment (SPA) for Phase 3 Trials of MDMA-Assisted Therapy for PTSD
On March 9, 2017, MAPS received a response from the U.S. Food and Drug Administration (FDA) as part of our Special Protocol Assessment (SPA) for our Phase 3 trial of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). The FDA provided comments based on a rigorous and lengthy review of the Phase 3 trial design to ensure the Phase 3 data will be accepted at the time of the New Drug Application (NDA). The first round of SPA comments has been received, and key design elements of the Phase 3 protocol have been finalized. We have been granted a Type A Meeting with the FDA on May 11 to discuss the comments.We are currently preparing for a Type A Meeting with FDA to discuss the comments. Learn more…
Therapist Training Study: 25th and 26th Participants Enrolled in Boulder
On March 1 and March 29, 2017, the 25th and 26th 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., and Ann Mithoefer, B.S.N., isare serving as Principal Investigators 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||
Conjoint Therapy for PTSD: First Pair of Participants Complete Six-Month Follow-Up Interview
On March 11, 2017, the first pair of participants completed their six-month follow-up interview in our new study of MDMA combined with Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD in our Charleston, South Carolina site led by Principal Investigator, Michael Mithoefer, M.D., and Sub-Investigator, Candice Monson, Ph.D. 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. Three dyads have completed treatment so far. 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. Learn more…
|$235,000 estimated study cost||$165,000 raised||$70,000 still needed||
MDMA/PTSD Phase 3 Therapy Training Program: Part D Training Begins
From March 18-23, 2017, 42 trainees from 7 U.S. states, 3 Canadian provinces, Israel, and the Netherlands participated in MAPS’ MDMA/PTSD Phase 3 Therapy Training (Part D) in Stony Point, New York. From April 1-7, another 42 Phase 3 therapists from the US, Canada, and Israel were trained at the YMCA of the Rockies, Estes Park, Colorado. These were the first times MAPS offered a Part D training, which consists of five and a half days of experiential learning in non-directive therapy, working with a co-therapist, bodywork, art, and non-ordinary states of consciousness. One day at each training consisted of Holotropic Breathwork™, facilitated by Diane Haug, Stacia Butterfield, Sharanya Naik (at Stony Point), and Colleen (at YMCA of the Rockies). Trainees got to experience non-ordinary states induced by breathing, alternating with the experience of sitting for another person. As is the case with MAPS’ Therapist Training Study, it is important for therapists to understand non-ordinary states of consciousness before treating subjects with MDMA-assisted psychotherapy. Holotropic Breathwork™ provides an accessible avenue for more trainees to gain this kind of hands-on training. Experiential work continued with role plays of situations that take place during MDMA-assisted psychotherapy sessions.
Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., shared case studies highlighting the non-directive approach as well as some of the unique challenges Phase 3 therapy teams might face, such as transference/countertransference and working with transpersonal experiences. Marcela Ot’alora, M.A., L.P.C., led a dialogue on team development.
MAPS Public Benefit Corporation (MPBC) Executive Director Amy Emerson and MPBC Clinical Data Specialist Alli Feduccia, Ph.D., joined the training staff to provide important information about screening, study design, and protocol. MPBC Training Program Coordinator Shannon Clare Petitt oriented trainees on the therapeutic use of music in psychedelic psychotherapy. MAPS Founder Rick Doblin, Ph.D., joined each group for the first several days of the training. Learn more…
MDMA-Assisted Therapy for Anxiety Associated with Life-Threatening Illness
Marin: 18th and Final Participant Treated
On March 13, 2017, the 18th and final participant was treated in our ongoing Marin, CA, 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…
|$627,000estimated study cost||$248,000raised||$379,000still needed||
4th, 5th, and 6th Participants Enrolled in Smoked Marijuana Trial for Chronic PTSD in Veterans
On March 13, March 15, and March 30, 2017, the fourth, fifth, and sixth participants were enrolled at the Scottsdale Research Institute (SRI) in Phoenix, Arizona, in the first-ever clinical trial of smoked marijuana (cannabis) for posttraumatic stress disorder (PTSD) in U.S. veterans. This clinical trial will evaluate the safety and efficacy of four different potencies of marijuana for symptoms of PTSD in 76 U.S. veterans.
On March 10, before enrolling a single subject, Johns Hopkins University elected to not participate as a clinical trial site for this study. JHU researchers wanted to focus just on the science but MAPS felt it necessary to focus both on the science and on the politics of the quality of NIDA’s marijuana and on ending NIDA’s monopoly on the supply of federally legal marijuana for FDA-regulated research. The funding agency, the Colorado Department of Public Health and Environment, signed a new contract with MAPS with SRI in Phoenix being the sole site where all subjects will now be recruited. Learn more…
To maintain transparency to the public and to ensure the reporting of accurate information, MAPS has released the results of the five rounds of secondary analytical testing of the chemical composition of NIDA cannabis. Read the statement…
Survey: Ayahuasca for PTSD
As of March 28, 2017, we have received 327 completed 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.
March Giving Report: Preparing for Phase 3
In March 2017, MAPS received $21,000 in new donations and pledges from 245 supporters. The new year marked our final negotiations with the U.S. Food and Drug Administration (FDA) as we move onto our final Phase 3 trials of MDMA-assisted psychotherapy for PTSD. We are still on track to make MDMA a medicine by 2021, and in the coming years our funding needs will grow substantially. Our Phase 3 trials will cost at least $25 million. With $10 million in hand, there’s still a funding gap we need to close.
We extend a special thanks to those who generously supported MAPS this past month:
- Bailey Gimbel ($2,500)
- Kirk Ahlberg ($1,000)
- David Carrico ($1,000)
- Oskar Demmer ($1,000)
MDMA/PTSD Phase 3 GMP MDMA
- Anja Saunders ($1,000)
- Jacob Sablosky ($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
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Browse our Event Calendar for more upcoming events.
Psychedelic Science 2017: April 19-24, 2017, Oakland, CA
CONFERENCE TICKETS NOW SOLD OUT
Even though tickets for the Three-Day Conference are now sold out, you can still be part of Psychedelic Science 2017. Join us in the free Marketplace from April 21-23, spend the evening with us at the free Celebrations on April 21 and April 22, or come dance at the Integration After-Party on April 23. You can also watch the entire conference online free shortly after the event on YouTube. You can also donate to help make psychedelic therapy a legal treatment.
Psychedelic Science 2017 is 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 Forums, 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. Learn how you can participate…
Psychedelic Science 2017 is presented by MAPS and The Beckley Foundation
Book Launch: The World Ayahuasca Diaspora: April 26, San Francisco, CA
Co-authors Beatriz Labate and Clancy Cavnar will present their new edited publication, The World Ayahuasca Diaspora: Reinventions and Controversies (Routledge, 2017). Leopardo Yawa Bane, from the Huni Kuin (Kaxinawa) tribe in the Brazilian Amazon will present reflections on the globalization of ayahuasca from an indigenous perspective. Leopardo Yawa Bane will be a featured presenter on the Psymposia Stage in the Marketplace at Psychedelic Science 2017. The book tackles questions surrounding the rapid expansion of the use of ayahuasca — a psychoactive sacrament that has long been associated with Amazonian shamanism. In it, scholars discuss the legal issues, economic inequalities, and other controversies tied to its expansion. Learn more…
Symposium: Psychedelic Science Research: April 25, 2017, San Francisco, CA
This symposium, hosted by the Psychedelic and Entheogen Academic Council (PEAC) at the University of California San Francisco (UCSF), and the Multidisciplinary Association for Psychedelic Studies (MAPS), will be focused on advancing the discussions around doing clinical trials in the United States to assess the safety and efficacy of ayahuasca in healthy participants and PTSD patients. The meeting aims to leverage the expertise of Brazilian researchers who have successfully conducted clinical trials on ayahuasca, and other related topics in the field of psychedelic science. This is a free event and will take place the day after Psychedelic Science 2017 ends. 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. Learn more…
International Drug Policy Reform Conference: October 11-14, 2017, Atlanta, GA
The International Drug Policy Reform Conference is a biennial conference hosted by the Drug Policy Alliance (DPA), a leading drug policy reform organization. Taking place in Atlanta, Georgia, this event unites researchers, politicians, activists, and others for educational discussions about the global effects of the war on drugs. MAPS is a proud to be an official Co-Host of this event. 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…