09 May 2025
The Psychedelic Revolution Will Not be Standardized
Lessons from MDMA-Assisted Therapy’s Trial by Regulation
By: Sara Gael, MA, LPC
Joseph McCowan, Psy.D
MAPS Bulletin: Volume XXXIV
Revolutions are not born of mere impatience. They are born of necessity. When the current conditions can no longer contain what is pressing to emerge, the old must give way to the new. In physics, a revolution is a return, a turning back to where things began — with the momentum and wisdom of nature in motion. In politics and culture, a revolution is a rupture, a breaking open of the known so that something freer and truer might emerge. In science, it appears as a paradigm shift, when the evidence becomes too loud to ignore and the old models crack under the weight of the new. Not often, and not easily, we see revolutions in medicine as well. When they arise, they demand that we loosen our grip on what is familiar in order to grasp what is possible.
Revolutions are not smooth. They threaten what is familiar. They demand our collective courage to reimagine. They make systems tremble and defenders of the status quo uneasy. Copernicus sparked a revolution when attempting to prove the Earth was in revolution around the Sun. He was subsequently silenced and slandered, but the theory lived on, and the revolution continued — not because it was accepted, but because it was true. Our eventual embrace of this reality forever changed our view of the universe, and our relationship to the cosmos.
Revolutions arrive not when our systems are ready, but when people begin to see more clearly. We now find ourselves here again, where something both ancient and new has come knocking. MDMA-assisted therapy and other psychedelic-assisted therapies have brought the field of mental health to the edge of a new threshold, and crossing that threshold could redefine health care as we know it. With the emergence of these treatments, the psychedelic revolution is here — offering a new way of understanding the very nature of healing. However, as with many revolutions before, it comes with little fanfare, and much critique. It comes challenging dogma, while layered with stigma. It asks us to question our assumptions. We are now faced with a decision: Do we deny the complexity of psychedelic-assisted therapy in order to fit it into a broken and failing system, or do we look to it as guides toward a new model of healing?
After the FDA’s decision to reject the new drug application submitted by Lykos Therapeutics for MDMA-assisted therapy for the treatment of PTSD, the psychedelic field experienced a shock. Those who worked directly on the clinical trials — including the three dozen or so therapists who had spent thousands of collective hours holding space for hundreds of participants — were left struggling to understand. Similar to the aftershocks of a traumatic event itself, many were left trying to make sense of what had happened, attempting to piece together fragments in search of meaning and a path forward.
While all of the factors that informed the FDA’s decision to not approve the novel drug + therapy are still debated and may never be fully understood, one thing is known —that the FDA’s instructions to Lykos should they ever want MDMA to be reconsidered—more research, more data on the potential for addiction, addressing functional unblinding, and combining MDMA with an evidence-based therapy are all on the table. While Lykos remains in gridlock with the FDA, millions continue to suffer, awaiting a treatment that has already demonstrated extraordinary potential.
MDMA-assisted therapy’s entry into the formal halls of medicine and science — down the sterile corridors of the FDA, and through the double-blind rigor of Phase 3 trials — has been nothing short of revolutionary. Not because it snuck in, but because it walked through the front door, bearing every credential, every safeguard, every scientific requirement demanded of it. And still, it was met with skepticism — and ultimately, rejection. Yet time has shown that revolutions are not stopped by skepticism, only delayed by it.
One of the most significant barriers MDMA-assisted therapy faced was that it was the first-ever new drug application for a combined drug + psychotherapy treatment. The FDA, which regulates drugs but not psychotherapy, had no precedent for how to evaluate such a model. The cards were stacked against it from the start. And beneath that structural confusion lies a deeper truth: MDMA is still a Schedule I substance. Were it not for the War on Drugs and the criminalization of psychedelics, MDMA and other psychedelic treatments might already be widely available. Now, decades and millions of dollars later, we are being asked to re-prove what many already know — and what communities across time and culture have long known — that psychedelics can help us heal. And with the guidance of skilled practitioners, that healing process can be magnified through a supportive, healing relationship.
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Faced with this regulatory impasse, the psychedelic field has splintered. On one side, organizations like MAPS and Lykos are doubling down on advancing the research while keeping the therapeutic model intact, holding fast to the belief that the relational component is crucial. Others — such as Compass and MindMed — are experimenting with stripping psychotherapy away altogether, favoring drug-only models with minimal support. Still others are advocating for fully autonomous models, removing human involvement entirely. The therapist/client healing relationship is undergoing trial-by-research.
As therapists, we are trained to support clients through cognitive dissonance — the discomfort that arises when two opposing truths are held at once. Our task is not to collapse the contradiction, but to help the person sit within it, until a more integrated truth can emerge. In this spirit, we invite the field — and the reader — to join us in that crucible. At the center of the dilemma between drug-only and therapy-enhanced models lies not just a scientific debate, but a deeper invitation: to imagine a third path — one that holds complexity, relationship, and mystery — without flattening them in the name of standardization and evidence.
Because one thing is becoming increasingly clear: research struggles to measure the “assisted” part of psychedelic-assisted therapy. It is messy, relational, and somatically rooted. It doesn’t neatly translate into quantitative metrics. The true psychedelic revolution is not what is published in the research. It is in the transformation of individual lives and in the messy and complex process of healing, which does not lend itself nicely to western reductionism. It is not found in graphs. It is in the quiet, nonlinear unfolding of a person’s return to themselves. It includes the spiritual, the transpersonal, and the relational. It includes the sacred. Psychedelics remind us that healing doesn’t happen in isolation. It happens in community, in relationship — with therapists, shamans, caregivers, ancestors. The therapeutic alliance is not a backdrop; it serves to help reconnect the client/participant to their humanity. It offers a mirror, a reflection, a reconnection. To remove it for convenience is to miss the point entirely.
The FDA’s rejection was not a failure of the therapy. It was a signal of the system’s unreadiness — a system still clinging to a paradigm that sees healing as something done to a person, rather than awakened within them. They look at the butterfly and ask it to fly like the caterpillar. But this is not how revolutions move. They do not wait for comfort. They do not ask for assimilation. They arrive when the world is aching for a new way forward. And we are aching. PTSD affects 12 million Americans each year. Suicide rates climb. The treatments we have are not enough.
And yet, the data is clear: Over 65% of participants in MDMA-assisted therapy no longer met criteria for PTSD after just three sessions. These were not mild cases. These were Veterans, survivors — people long failed by the standard of care. They did not find a miracle given to them — they found healing awakened within them.
MDMA-assisted therapy is not just a new treatment. It is a new way of understanding suffering — and a new way of being with it. It is built not on dominance, but on trust. Not on symptom suppression, but on transformation. It is built on the radical premise that people can heal, if given the space, the support, and the tools to do so.
To witness this transformation is to witness the sacred. It is not mechanical. It is not linear. It is the slow stirring of something that remembers itself. The medicine softens the noise so the soul can speak. The therapist holds the lantern while the psyche finds its way. And from that cocoon, something new is born. And yet — despite all of this — the FDA turned it away. Not because the therapy failed, but because they did not know how to receive it.
While understanding mechanisms of action is undoubtedly important — and while research is vital — it is also true that the last 20 years of psychedelic research has largely been about legitimacy. We submitted psychedelics to the lens of Western scientific reductionism not because it was the best fit, but because it is the dominant and societally accepted lens. But psychedelics teach us about the limits of our lenses. They show us what lies beyond the rational mind, beyond ego, beyond convention. Psychedelics were never meant to be reduced to fit our current standards and models. They are meant to expand perspective — to reveal what our current paradigms cannot see.
Of course, science has a very important role in our understanding of psychedelics. But when we elevate only the scientific— and exclude spirit, relationship, and mystery — we fragment the whole. And in doing so, we re-enact the very trauma these medicines are trying to heal. In this way, psychedelics are recovering from trauma too — the trauma of being forced into a model that refuses to see their full complexity. Psychedelics ask us to reunite what’s been divided — not just within people, but within systems.
Western science’s engagement with psychedelics is a mere flash in the pan compared to millennia of Indigenous knowledge. Indigenous wisdom calls for the inclusion of the unseen-of spirit, and the recognition of the sentience of all things. This animistic lens is ancient, cross-cultural, and pre-colonial. This lens and worldview has, for over half of a millennium, been actively targeted by colonial powers which have insisted on the superiority of their lenses. These medicines were once banned, demonized, and stripped from cultures that held them as sacred. And now — in a tragic twist — the same systems that once criminalized them now demand to be convinced of their validity. Let us not forget: this system is the one that failed so many in the first place. Psychedelics gained momentum because the mental health system isn’t working. Any lens that does not account for this reality — or the role of colonialism and white supremacy in shaping that system — is incomplete.
To those standing at the gates of this new world — regulators, researchers, clinicians — we invite you to look again. Look not with the eyes trained only on the past, but with the courage to see what is emerging. Look as light through a prism, not a beam of white certainty. Let complexity show its colors. Let ambiguity stretch your definitions. Let the data speak — but let the people speak too.
This revolution does not come to fit into your systems. It comes to reveal where your systems must grow. It asks not for favor, but for vision. Not for permission, but for presence.
Electricity was once dismissed as dangerous magic — until we learned to conduct it, not contain it.
The energy of healing calls for us to be conductors, not controllers — allowing the current of transformation to move through us, even if we have not yet mapped out all its circuits. Let us meet this moment with the humility it deserves. Let us not be the ones who clipped the butterfly’s wings before it ever took flight —mistaking fragility for failure, and potential for threat. Can we be the prism, not the pane —the vessel that reveals the full spectrum, color, and complexity? Will we abandon the sky because we don’t yet see clearly? Or will we raise the telescope, adjust the lens, and be curious about what comes into focus?
Sara Gael, MA, LPC
Sara Gael MA, LPC is a psychedelic therapist, educator, and organizational leader with expertise in risk reduction, peer support, and community movement-building. She is co-founder and Lead of Strategic Development at Memoru Center for Visionary Healing Arts. Sara holds a Master’s degree from Naropa University in Transpersonal Counseling Psychology with a concentration in Nature-Based Therapy. While at Naropa she co-founded the student group, Naropa Alliance for Psychedelic Studies (NAPS). She was an Investigator/therapist for Lykos MDMA-Assisted Therapy for PTSD Clinical Trials and serves as a Lykos Lead Educator, Training Consultant and Associate Supervisor.
Sara worked at the Multidisciplinary Association for Psychedelic Studies (MAPS) for ten years, serving as Director of Harm Reduction and stewarding the work of the Zendo Project. She was an appointed representative on the Denver Psilocybin Mushroom Policy Review Panel from 2019-2024 and she spearheaded the MAPS City of Denver First Responder Psychedelic Crisis Assessment and Intervention Training. She served as board president for DanceSafe and supports multiple organizations in the psychedelic field as an advisor and consultant. Sara was the founding Course Director for the Integrative Psychiatry Institute’s Psychedelic Assisted Therapy Training, overseeing a global faculty of over 30+ esteemed mental health experts and developing over 300 hours of curriculum, impacting over 2,000 students.
Sara comes from mixed white/Hispanic ancestry and was raised in Northern New Mexico where her ancestors have lived for over 20 generations. Central to her own healing journey has been connection to land and the natural world. She has held a relationship with psychedelics for over 25 years and they have supported her in navigating her own personal and transgenerational trauma. She believes in the potential of psychedelics as catalysts for individual, community, and collective healing and is committed to equitable access for historically and currently marginalized communities.
Dr. Joseph McCowan, Psy.D.
Dr. Joseph McCowan, Psy.D., is a licensed clinical psychologist based in Los Angeles. Joseph brings extensive experience in psychedelic-assisted therapy, education, and clinical research. Dr. McCowan served as a Co-Therapist and Supervisor in the MAPS-sponsored Phase 3 clinical trials of MDMA-Assisted Therapy for PTSD, and supported the MAPS MDMA Therapy Training and Education program as a Lead Educator and Consultant. In addition, Dr. McCowan played a pivotal role in advancing diversity within the MAPS clinical studies as a member of the MAPS Diversity Working Group, focusing on increasing representation among therapists and participants from underrepresented communities.
Currently, Joseph is a therapist in the Compass Pathways Phase 3 studies of Psilocybin-Assisted Therapy for Treatment-Resistant Depression and serves as a Lead Trainer with Fluence, providing education in Psychedelic-Assisted Therapy. Previously, Dr. McCowan offered Ketamine-Assisted Therapy and Psychedelic Integration Therapy at the California Center for Psychedelic Therapy. His work is deeply rooted in his commitment to increasing awareness and accessibility of psychedelic therapies, particularly within communities of color and historically underserved populations.
Dr. McCowan earned his undergraduate degree in psychology from the University of California, Santa Barbara, and his Doctorate in Clinical Psychology from the Chicago School of Professional Psychology. He serves on the Board of Directors for Lykos Therapeutics and Chacruna.
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