MAPS is making increasing progress as we enter the final phase of our 36-year-long — and ongoing — journey to medicalize the therapeutic use of MDMA-assisted therapy, initially for PTSD and then for other clinical indications.
Yet in the face of so much progress, we continually seek to improve the safety and efficacy of our therapeutic work. While we are thrilled with the positive results, we are sobered to know that this treatment simply does not work for everyone. Some, we have learned, feel that additional sessions, fewer sessions, or more flexibility with the timing of sessions would have been more supportive. For others, the path to improved symptoms may be circuitous or especially difficult after the treatment ends. We have worked to allow some additional integration sessions within the trials, but the restrictions associated with clinical trial protocols limit our ability to work with clinicians to personalize treatment programs. Nonetheless, we can learn as much — if not more — from the experiences of participants who do not experience clinically significant symptom improvement.
We are encouraging all subjects who have been treated in our PTSD studies to participate in our long-term follow-up so that we can gather accurate information about the durability of the treatment effect, if any, and about challenging outcomes for participants, all of whom had severe PTSD prior to enrolling in the study.
As we have received news that the National Center for PTSD now estimates that 12 million Americans are living with PTSD, we are as dedicated as ever to ushering this novel treatment for PTSD through regulatory approvals (and always learning along the way). In the U.S., Canada and Israel, MAPS has already enrolled the 100 people — all with moderate to severe PTSD — required for our second Phase 3 study. An interim analysis was conducted in May and the final data point will be gathered near the end of 2022. If the second Phase 3 study is statistically significant and no new safety problems arise, MAPS will have conducted two successful Phase 3 studies. If so, while not assured, we are on track to receive regulatory approval from FDA, Health Canada, and the Israeli Ministry of Health. Mike Mullette, the new COO of the MAPS Public Benefit Corporation, formerly Vice President and Managing Director of North America for Moderna, is expertly helping us to prepare for post-approval access by prescription, building a large new team for patient access and commercialization.
In the US Veterans Administration, veterans with PTSD have already been treated at the Loma Linda VA outside of Los Angeles and at the Bronx VA. In March, the Bronx VA hosted a therapist training program for about 60 VA therapists from 18 VA medical centers around the country. The FDA recently indicated that it will approve a protocol for research into MDMA-assisted group therapy for PTSD at the Portland, Oregon VA. The Principal Investigator (PI) of the Portland OR VA group therapy study, Dr. Chris Stauffer, presented an enthusiastically received webinar on MDMA-assisted therapy for PTSD that was attended by over 975 VA therapists.
In Europe and England, MAPS is in the process of training therapists in seven countries (Netherlands, Czech Republic, Germany, Portugal, Spain, Norway, and England) in preparation for launching a Phase 3 trial within a year. Ten people living with PTSD have already been treated in Phase 2 trials, and another 30 or so will be treated in conjunction with training of therapists in these seven countries. Regulatory approval by EMA is targeted for about a year or two after approval in the US. Research into MDMA-assisted therapy for PTSD is also starting in Australia and has already been conducted in Brazil. MAPS is also working to start humanitarian research to treat people with PTSD in Armenia, Ukraine, Somaliland, South Africa, and elsewhere around the world where PTSD is widespread.
MAPS is moving forward with planning for what we anticipate will be the world’s largest psychedelic conference ever held, Psychedelic Science 2023, from June 17-25, in Denver at the Denver Convention Center. The field of psychedelic research is at the doorway of potential regulatory approval for prescription use. Drug policy reform is moving forward with the decriminalization of plant-based psychedelics in an increasing number of U.S. state and local jurisdictions. State-legal access to therapy with psilocybin is being implemented in Oregon and on the ballot for Colorado in November 2022. Psychedelic Science 2023 will provide space for the leaders and learners across the spectrum of the psychedelic renaissance.
Beyond Psychedelic Science 2023, we’re also starting to plan for the celebration of MAPS’ 38th anniversary on April 8, 2024, when the universe itself is celebrating with a full solar eclipse visible along a band of the US. Another full solar eclipse won’t take place across the US for another 20 years, and not on MAPS’ anniversary. All are invited to join us at a location still to be determined for MAPS’ 38th anniversary and the full solar eclipse.
Rick Doblin, Ph.D.
MAPS Founder and Executive Director
Rick Doblin, Ph.D., is the founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS). He received his doctorate in Public Policy from Harvard’s Kennedy School of Government, where he wrote his dissertation on the regulation of the medical uses of psychedelics and marijuana and his Master’s thesis on a survey of oncologists about smoked marijuana vs. the oral THC pill in nausea control for cancer patients. His undergraduate thesis at New College of Florida was a 25-year follow-up to the classic Good Friday Experiment, which evaluated the potential of psychedelic drugs to catalyze religious experiences. He also conducted a thirty-four year follow-up study to Timothy Leary’s Concord Prison Experiment. Rick studied with Dr. Stanislav Grof and was among the first to be certified as a Holotropic Breathwork practitioner. His professional goal is to help develop legal contexts for the beneficial uses of psychedelics and marijuana, primarily as prescription medicines but also for personal growth for otherwise healthy people, and eventually to become a legally licensed psychedelic therapist. He founded MAPS in 1986, and currently resides in Boston with his wife and three children.