This issue of the Multidisciplinary Association for Psychedelic Studies (MAPS) Bulletin presents our annual financial report for Fiscal Year 2018 (June 1, 2017–May 31, 2018). As you will see, this has been MAPS’ most successful year ever. Astonishingly, we have now raised $27 million for U.S. Food and Drug Administration (FDA) Phase 3 research into MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD)!
In the last few months, we have made unprecedented progress in growing public acceptance for research into psychedelic psychotherapy, especially MDMA-assisted psychotherapy for PTSD. The most satisfying moment for me was on October 8 in Orlando, Florida, when I spoke at the annual conference of the International Association of Chiefs of Police (IACP), along with Jon Lubecky, a veteran who was successfully treated for PTSD in our Phase 2 research; Dr. Zhenya Gelfand, a psychiatrist working at our South Carolina Phase 3 site; Tony Coulson, our retired senior DEA official consulting for MAPS. Together, we discussed how MDMA-assisted psychotherapy could be used to help police officers suffering from PTSD. (President Trump decided unexpectedly at the last minute to speak at the same conference and his talk was scheduled at the same time as ours!) After our talk, one police therapist approached us to mention his interest in going through our therapist training program. It was an incredible experience to speak at IACP, and to feel that our presence was both welcomed and appreciated.
Two days after the police chiefs conference, I was back home speaking in Cambridge, Mass., at the Broad Institute, a genomics research center with scientists from MIT and Harvard, at a conference sponsored by the Harvard Brain Science Initiative, Harvard Medical School, the Broad Institute, the Gift Holotropic Association, and MAPS. Also speaking was Michael Pollan, author of the New York Times bestseller How to Change Your Mind (a book which has changed lots of minds), along with psychedelic researchers Matt Johnson from Johns Hopkins, Robin Carhart-Harris from Imperial College London, Dr. Franklin King from Massachusetts General Hospital, Anja Loizaga-Velder from the Nierika Institute in Mexico, and moderator Julie Holland. From IACP to Harvard, psychedelic research has obtained academic respectability and mainstream acceptance.
The remarkable progress we are making in public education was exemplified in an excellent seven-minute video from The Economist (“How MDMA is being used to treat PTSD,” October 11) and a CBS Evening News “Eye on America” special report (September 18), and much more. You can view these and other recent news items on our website (maps.org/media).
Excitement about MDMA-assisted psychotherapy for PTSD research is growing internationally as well as in the U.S. At the end of September, our therapist training team led a six-day therapist training program in the Netherlands for about 60 therapists from 14 different countries. This training was preparation for our efforts to conduct Phase 3 MDMA-assisted psychotherapy for PTSD trials in Europe through the European Medicines Agency (EMA).
Before I went to the European training, I was in China speaking about our research efforts to Chinese psychiatrists and PTSD experts at a conference organized by the Chinese Society of Psychiatry and Chinese Medical Association. Joining me was Dr. Moshe Kotler, Principal Investigator of our completed Israeli Phase 2 MDMA trial. Amy Emerson, Executive Director of the MAPS Public Benefit Corporation (MPBC), was also in China speaking to Chinese psychiatrists and PTSD experts two weeks before Dr. Kotler and I arrived. Our presentations were sufficiently inspiring, and there is now interest among Chinese therapists and researchers in participating in our therapist training program. Our travel was funded by a MAPS donor who wants to help bring MDMA-assisted psychotherapy for PTSD research to China.
By the time you are reading this, MAPS’ Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD will finally have begun screening participants. This is a momentous milestone for MAPS. We anticipate our U.S. Phase 3 trials will take about two years to complete, at which point the data will be submitted to the FDA along with our request to approve MDMA-assisted psychotherapy as a legal treatment for PTSD. We anticipate that our European Phase 3 trials will start in the second half of 2019 or early 2020, depending on how long it takes for regulatory approvals, and for MAPS to raise another $9 million in donations to fund the European trials.
We’ve also recently enrolled the 76th and final participant in our Phase 2 clinical trial of four different varieties of smoked cannabis for veterans with chronic, treatment-resistant PTSD. We will be able to remove the blind and begin data analysis in the first few months of 2019.
The greatest challenge we now face is to successfully manage our organizational growth, with over 45 staff at MAPS and MPBC combined, and more to come as we scale up for Phase 3 trials, Expanded Access, and therapist training. As we approach 2019, the opportunities are ever-increasing, as is the need to make psychedelic-assisted psychotherapy a legally available treatment for PTSD and many other conditions. With the continued support of MAPS donors, I am confident that next year will be even more astonishing than this one.
Rick Doblin, Ph.D.
MAPS Founder & Executive Director