The psychedelic research renaissance, initially funded only by philanthropy and government grants, is generating increasingly promising data about therapeutic applications, and new understandings of the mechanisms of action. The recent rise of for-profit psychedelic companies has generated previously unobtainable amounts of capital for psychedelic drug development research and associated establishment of psychedelic therapy clinics, starting with ketamine clinics for the treatment of depression.
The FDA has awarded Breakthrough Therapy status to MDMA-assisted therapy for PTSD and psilocybin-assisted therapy for treatment-resistant depression and for major depressive disorder. On May 4, 2021, the New York Times published an article about the outstanding results of MAPS’ first Phase 3 study. On May 10, 2021, Nature Medicine published our scientific paper about our Phase 3 results: “MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study,” and the New York Times published a front page article entitled, “The Psychedelic Revolution Is Coming. Psychiatry May Never Be the Same.”
Only a few years of additional research and regulatory review is necessary before FDA, the European Medicines Agency (EMA), and other international regulatory agencies will decide whether or not to approve the prescription availability of these treatments.
Planning ahead in the eventuality of approval, it’s immediately apparent that training a sufficient number of therapists is the primary challenge to meet the needs of millions and millions of patients around the world with PTSD and depression.There are about 8 million people in the US suffering from PTSD and more than a million veterans currently receiving disability payments for PTSD totaling in the range of $17 Billion a year, with around 350 million people worldwide with PTSD. Even more therapists need to be trained if regulatory approval is also obtained for other clinical indications such as substance use disorders, eating disorders, obsessive-compulsive disorders, social anxiety. Still more therapists will be needed if we eventually build a post-prohibition world with legal access to psychedelic therapy for the normal struggles of life such as the search for meaning and purpose, couples therapy, grief, aging, illness, and death.
The field of psychedelic therapy that is developing will ideally involve therapists becoming cross-trained in delivering MDMA, psilocybin, ketamine, and other psychedelics that may become approved over the years to come. Future psychedelic clinics are unlikely to be specialized to use just one psychedelic but will be able to offer personalized treatment plans that may involve a sequence of psychedelics over time.
The responsibility for training therapists lies in part with the pharmaceutical sponsors of the research who developed the treatment and obtained regulatory approval for prescription uses. These sponsors will train therapists in the specific methods used in the Phase 3 trials designed to try to prove safety and efficacy. Sponsors will also engage in discussions with FDA regarding minimum licensing credentials for psychedelic therapists. To scale the training, the content of the sponsors’ training programs can also be delivered by academic and medical institutions, incorporated into training programs offered by other trainers, or government agencies like the VA.
The training of new therapists is on the critical path to actually treating more people. What follows is a discussion of what credentials will likely be necessary to legally provide psychedelic therapy, and options for obtaining these credentials. This discussion is intended for students as well as practicing physicians, therapists, and chaplains. It’s also intended for a group of people to whom this new field of psychedelic-assisted therapy owes a debt of gratitude, the courageous pioneers who operate as underground therapists. Many have a great deal of experience and skill, but who may lack the necessary credentials to operate in regulated clinics.
In addition to the renaissance in psychedelic research, we are also seeing an expansion in the use of plant psychedelics in legally-protected religious contexts, such as ayahuasca in the Unio De Vegetal (UDV) and Santo Daime religions. The use of peyote in the Native American Church is also legally-protected. The credentials for leading ayahuasca and peyote circles are determined by those religions and are not discussed below.
The Clinic Model: FDA Current Requirements
The future of legally-licensed psychedelic psychotherapy will be based on a team model with physicians and therapists operating together with a physical clinic with in-person therapists for preparation, treatment and integration of psychedelic sessions supplemented by some virtual non-drug preparation and integration sessions. A Physician Prescriber will hold the DEA license for the psychedelic(s), which will remain a controlled substance. Physicians will be responsible for the medical screening of patients and will be on call during MDMA sessions.
Currently, the team’s minimum requirements are:
- One physician licensed to manage and administer controlled substances for each site, To become authorized to be a prescriber of MDMA, psychiatrists and other physicians need to pass a several hour training program conducted by the sponsor focusing on safety.
- A physician to assess participant safety at screening with either a physician on call or on site during the psychedelic sessions
- Two-person therapy teams for individual therapy, different ratios of facilitators to patients in group therapy contexts
- One person per therapy team is required to be licensed to provide psychotherapy according to state and local requirements with FDA withdrawing its requirement that the lead facilitator be an MD or PhD after MAPS filed a Formal Dispute Resolution Request with FDA.
- If one person on the therapy team is unlicensed, they will need to have a bachelor’s degree and be in a program for licensure, or have 1000 hours of mental health treatment experience. They would work under the direct supervision of the licensed team member
- All facilitators, licensed or not, who will interact with patients during MDMA sessions will need to go through a training program designed by the sponsor in the specific treatment method used in the Phase 3 studies.
At present, there will need to be a doctor writing the prescription for a psychedelic. Initially, only doctors will be able to prescribe psychedelics. There are only five states—Louisiana, New Mexico, Illinois, Iowa, and Idaho—that permit psychotherapists with special educational and training requirements to prescribe a limited set of psychiatric medications. However, these medications are not controlled substances such as MDMA and psilocybin, which will initially remain federally controlled substances even if rescheduled to permit medical use by prescription. As a result, a physician will need to be part of the teams that will be required for the therapeutic administration of psychedelic-assisted psychotherapy. This is currently the case for prescribing ketamine for depression which was approved as a pharmacological treatment without associated psychotherapy.
FDA is no longer seeking to impose a new requirement that there be a doctor on site for administrations of MDMA. In 2017, for MAPS’ Phase 3 studies of MDMA-assisted therapy for PTSD, FDA signed a formal Agreement Letter with MAPS to successfully conclude the Special Protocol Assessment (SPA) process in which we agreed that a doctor was required to be on call during the MDMA sessions but not on site.
Since that time, FDA has imposed on psilocybin research conducted by for-profit Compass Pathways and non-profit Usona the requirement that there be a physician on site during the administration of psilocybin. FDA then imposed that physician on site requirement on all new non-Phase 3 studies of MDMA conducted by MAPS. Unless successfully challenged, FDA might try to impose the requirement of a physician on site for all post-approval prescription use, effectively making it too expensive for sole practitioners or small groups of therapists to compete economically with large clinics, leading to chains of large treatment centers.
In the context of an FDA Formal Dispute Resolution process, MAPS successfully challenged the FDA’s new requirement that there be a doctor on site. The physician would need to conduct a medical screening process for health contraindications and monitor patients who will be required to taper off of their other psychiatric medications. MAPS proposed, and senior FDA leadership agreed, that the physician be required to be on call during the administration of the MDMA but not on site.
In the same FDA Formal Dispute Resolution process, MAPS also challenged the FDA’s new requirement that the lead therapist be either an MD or a PhD. FDA agreed in the SPA process that for MAPS’ Phase 3 studies, the lead therapist needs to be licensed to conduct psychotherapy but doesn’t need to be an MD or PhD. Since that agreement, FDA has imposed this new licensing requirement of an MD or PhD for the lead therapist on all new MDMA studies and on psilocybin studies. FDA has been engaging in bureaucratic self-protectionism with this requirement of an MD or PhD as the lead facilitator. This policy is not based on actual data about how these credentials will lead to increased safety or efficacy, or on any actual data about how the lack of these credentials has led to increased safety risk or decreased efficacy. Fortunately, FDA has now abandoned this requirement of an MD or PhD for the lead therapist for research with MDMA, with positive implications for psilocybin.
In the current two-facilitator model, the second person does not need to be a fully licensed therapist. The second person currently needs to have a bachelor’s degree, a requirement that MAPS and perhaps other sponsors will eventually challenge but which has of yet not been challenged. The second person either needs to be enrolled in a program to obtain a license to conduct therapy or have 1000 hours of experience in mental health, not precisely specified.
In order for a single therapist to treat a patient with psychedelic-assisted therapy, sponsors of research would need to conduct clinical trials with a single therapist and then compare results on both safety and efficacy to that produced by a two-person therapy team. Research into the use of a group therapy model has begun with psilocybin and is in the process of protocol development for MDMA. In the psilocybin group therapy model, there were four subjects treated simultaneously in separate rooms each with a single therapist in the room. In addition, there was a senior supervisor and assistant observing the events in each room through live video feed and entering a treatment room in order to provide additional support or guidance when helpful or necessary. In this study, all therapists were fully licensed. Future studies of group therapy may involve facilitators who are not yet or don’t ever plan to become licensed to provide therapy working under the supervision of licensed therapists.
Sponsor-Provided Training Requirements
MAPS, Compass Pathways, and Usona, and other psychedelic research companies, are all developing their own therapeutic approaches for use in Phase 2 and Phase 3 studies. Should any of these companies obtain approval for prescription use of psychedelic-assisted therapy, therapists who want to administer these treatments by prescription will need to go through training programs designed by the sponsors into the treatment methods that were approved by FDA. Information about these training programs is posted on the websites of these companies. MAPS has posted its Treatment Manual on its website along with information about our therapy training program. Usona Institute discusses facilitator qualifications and training in the FAQ section of the About page on their website. Compass Pathways has published a paper about their training program.
Sponsors will also offer shorter and separate trainings for prescribers who don’t want to offer therapy.
Academic Institutions with Psychedelic Therapy Training Programs
The California Institute for Integral Studies (CIIS) has been a pioneering academic institution that has created a certificate (non-degree) program in Psychedelic-Assisted Therapies and Research. CIIS and MAPS have collaborated on including a part of MAPS’ therapist training program into the curriculum offered by CIIS. People who receive the CIIS certificate are considered by MAPS to have completed part but not all of its training program.
MAPS has also collaborated with Naropa University in offering a part of its MDMA therapist training program. As with CIIS, the program offered by Naropa is not yet part of their degree programs but is a certificate program. Both CIIS and Naropa are exploring the possibility of adding training in psychedelic-assisted therapy into their degree programs.
MAPS is in the early stages of discussions with the University of Baltimore about adding part of all of our therapist training program into their counseling program for academic credit.
Rachel Yehuda, Ph.D, a researcher at the Bronx VA and the Icahn School of Medicine at Mount Sinai, is working to implement MAPS’ therapist training program inside the VA system, potentially to train thousands of VA therapists in MDMA-assisted therapy.
Independent Therapist Training Programs
A new company, Fluence, with trainers who have gone through MAPS and Compass training programs, offers “Professional Education in Psychedelic-Assisted Psychotherapy and Integration”. Fluence’s training program, while informed by MAPS and Compass’s training program, does not yet substitute for the training programs of these sponsors. One day, these sponsors may one day authorize graduates to be considered to have completed parts or all of their training programs.
A new therapist training program is the Integrative Psychiatry Institute (IPI) Online Psychedelic-Assisted Therapy Training, which is open to a wide range of professionals (LPC, LMFT, LCSW, Clinical Psychologists, Counseling PhD and PsyD, Psychiatrists, Psychiatric Nurses, MDiv., MD, and BCC-Board Certified Chaplains). This certificate course offers an outstanding general education that doesn’t currently substitute for sponsor training programs, though MAPS is in discussion with IPI about collaborating to offer part of its MDMA therapist training program in the curriculum offered by IPI.
Lila Vega, a Columbian therapist trained by psychedelic research pioneer Dr. Claudio Naranjo, has created the Onca Foundation which offers an experiential training program called Psychedelic Therapy Training Into the Transpersonal. This training program is described as follows: “Half of the program (600 hours) is committed to our non-residential program led by leaders and pioneers in the psychedelic field. The other half is committed to experiential work in our intensives: therapy retreats, dietas, initiations, and pilgrimages. Half of the intensives are focused on experiential transpersonal therapy, the other half take place in indigenous territories: Cofan reservations in the Amazon, a Bwiti village in Africa, and Wirikuta the peyote pilgrimage site in Mexico.”
Hakomi, Somatic Experiencing, and the Grof Legacy Training in holotropic breathwork are other training programs that teach useful lessons for future psychedelic therapists. A large list of other psychedelic therapy training programs is offered on the website of the Organization of Psychedelic & Entheogenic Nurses Organization (OPEN). None of these programs substitute for sponsor training programs but they are excellent preparation for those programs.
MAPS’ Zendo Project provides training in acute psychedelic harm reduction that will become a certificate program. This is aimed at training people for peer support and is a good preparation for learning how to provide psychedelic therapy. MAPS is also developing a MAPS Psychonaut training based in part on psychedelic harm reduction principles but also providing information about benefit enhancement.
Personal Experience as Fundamental Training
This discussion of training opportunities for future psychedelic therapists would not be complete without mentioning that personal experience is one of the most important elements in training. Starting with Freud’s development of psychoanalysis where practitioners were required to go through their own psychoanalysis, personal experience has been a central feature of training psychoanalysts and psychotherapists.
MAPS’ training program has involved an FDA-approved protocol to study the effect of MDMA administered to healthy volunteers on the Profile of Mood States-Bi Polar Version, on personality traits as measured by the Neuroticism-Extroversion-Openness Personality Inventory (NEO), and on scores on the Measure of State Interpersonal Closeness (IPC). The protocol limits enrollment to people in MAPS’ therapist training program. About 90 people have volunteered for this protocol with a survey of these participants endorsing the value of their participation both to their professional skills and to themselves personally. This protocol has been approved by the FDA for up to 120 subjects. FDA has now removed its Clinical Hold on a new protocol to study MDMA and self-compassion in another 150 people. Offering this protocol is the most expensive part of MAPS’ training program and also one of the most valuable. Nevertheless, MAPS’ view is that it should never be required that therapists receive MDMA as part of their training and that it should always remain optional.
Other sponsors of psilocybin and other psychedelic research have not yet created a protocol for their therapists in training to volunteer to receive psilocybin or other psychedelics. In part this is because of the expense, also because of the concern that this sort of protocol is controversial, that there are legal options in Jamaica and the Netherlands for therapists to travel to receive psilocybin, and there are US state and city options for self-experimentation in areas that have decriminalized mushrooms or made them the lowest enforcement priority.
Other forms of personal experience outside of protocols, like religious use of ayahuasca, are also valuable for the training of therapists.
As the field of psychedelic research continues to expand, with the likelihood that MDMA and psilocybin will be approved by the FDA and EMA for prescription use in the next 2-4 years, the need for psychedelic therapists will continue to grow. The most certain plan going forward for people to work as psychedelic therapists in this emerging industry will be to obtain academic and professional credentials that allow work as a therapist, and then to obtain specialized training in psychedelic therapy from the sponsors who obtained permission for prescription use. These training programs will eventually be part of academic programs for psychiatrists and therapists that will incorporate training in psychedelic therapy.
Fortunately, there will also be a role for unlicensed but experienced and trained facilitators who would work under the direction of licensed psychedelic therapists as interns, students, apprentices and helpers. These roles for unlicensed facilitators will be possible in settings of both individual and group therapy. FDA requirement of a bachelor’s degree for the co-facilitator seems difficult to defend and should eventually be challenged.
The degree to which psychedelic therapy can scale to treat the hundreds of millions of people around the world with PTSD, depression, substance abuse, anxiety, and many other clinical indications will depend on the ability to train skilled, sensitive therapists.
We’re just at the beginning of the psychedelic renaissance!