Op-Ed: Psychedelics in Practice: What the State Programs Are Teaching Us

Here at Psychedelic Alpha, we spend a great deal of time writing about the pursuit of regulatory approval for psychedelic medicines, with a key focus on the FDA pipeline, but we also cover other pathways to psychedelic access that don’t hinge on traditional marketing authorisation.

While some of those pathways have emerged internationally—such as in Switzerland, Germany, and Australia—certain U.S. states are acting as ‘laboratories of democracy’ by establishing state-regulated access programs. The first such program was established in Oregon, where psilocybin service centres opened their doors to clients in 2023. In 2025, Colorado’s ‘natural medicine program’ launched, and New Mexico’s medical psilocybin program is expected to get off the ground in December 2026, a year ahead of schedule.

With the exception of New Mexico’s Medical Psilocybin Act, these systems are not explicitly medical in nature, and many healthcare professionals have struggled to become involved due to concerns over their licenses, due to the federal illegality of psilocybin. Still, the majority of clients accessing psilocybin services via state-legal models report doing so in an attempt to deal with mental health conditions or for some kind of wellbeing-related reason, with the total number of clients served far outpacing clinical trial participant counts.

One group that has played a substantial role in the implementation of these programs is the Healing Advocacy Fund. Here, in the first of a series of Op-Eds that focus on alternative psychedelics access models, the nonprofit’s Executive Director, Taylor West, shares her views on how these state programs are shaping up and what we might learn from them.

Note: This is a guest article. As such, the views expressed herein do not necessarily reflect the views of Psychedelic Alpha or its editors.

While the FDA captures headlines, Oregon, Colorado, and New Mexico are quietly proving what works in real-world psychedelic therapy and shaping the future of care.

Much of the psychedelic sector spent 2025 riding the FDA rollercoaster, tracking trial timelines, parsing regulatory signals, and speculating about approval pathways. Meanwhile, with far less attention, state-regulated psychedelic therapy programs have been quietly revolutionizing the field.

Right now, these programs are doing what no federal pathway yet has—delivering legal, regulated, therapeutic psychedelic care at scale.

This matters more than many in the field currently appreciate. While FDA approval may determine whether a molecule becomes legal, it will not, on its own, determine what psychedelic therapy actually becomes. That future is being shaped in the states today.

Across Oregon and Colorado, more than 15,000 people have already received legal, regulated, therapeutic psychedelic care. Most of these clients have come through Oregon’s program, which opened in 2023. In Colorado, Healing Advocacy Fund estimates that more than 400 people have been treated since this summer, with client numbers expected to grow quickly under Colorado’s more flexible licensing structure.

These programs are not clinical trials or tightly controlled pilots. They are functioning systems, operating in the open, serving people with complex lives, co-occurring conditions, and needs that don’t fit neatly into diagnostic boxes. They are helping people who are seeking relief, healing, and a way forward where other treatments have fallen short.

At the same time, states like New Mexico are experimenting with different regulatory approaches, introducing new ideas about how psychedelic therapy might integrate with existing healthcare systems.

These programs are doing two things at once: helping thousands of people today, and laying the foundation for what psychedelic therapy could and should look like for millions in the future.

What’s Actually Happening in the States

Oregon and Colorado are currently the only U.S. jurisdictions providing psychedelic therapy at meaningful scale through legal, regulated frameworks.

In just a few years, these programs have moved beyond theory into practice, serving thousands of people across a wide range of backgrounds and needs. Early data show consistently high client satisfaction, extremely low rates of serious adverse events¹, and growing evidence of benefit across depression, anxiety, addiction, trauma, and end-of-life distress.

Just as important, these programs are doing something clinical trials cannot: They are testing how psychedelic therapy works in real life, across diverse populations, practice settings, facilitator backgrounds, and regulatory environments.

In Oregon, for example, Healing Advocacy Fund led nearly two years of collaboration among facilitators, service centers, healthcare providers, and policymakers to create and pass legislation refining safety standards, clarifying regulations, and strengthening the psilocybin program’s integration with broader health systems. These efforts show how state programs are actively evolving to meet participant needs while generating insights that other states and future federal frameworks can build on.

More broadly, the state programs allow a fundamental shift from proving that psychedelic therapy can work, to showing how it does work in real communities.

Multiple Models, Shared Momentum

New Mexico is taking a different approach from Oregon and Colorado, emphasizing medical and behavioral health integration from the outset. The program is exploring how psychedelic therapy might connect more directly with licensed healthcare systems, traditional care pathways, and, eventually, public and private insurance coverage.

This is not an evolution toward a “better” model, nor a repudiation of earlier state approaches; it is another data point in a growing ecosystem of experimentation.

Together, Oregon, Colorado, and New Mexico represent a spectrum of possible futures for psychedelic therapy, including community-based access, medically integrated care, and hybrid approaches that blend the two.

And while full health insurance coverage is likely still years away, state programs are developing models in which the therapeutic portion of the care may be eligible for reimbursement before any decisions are made on the medicine.

The Research and Policy Engine the Field Actually Needs

One of the most underappreciated roles of state programs is how they function as a real-world research and policy engine for the field, producing evidence the FDA pathway simply cannot.

Clinical trials are, by design, narrow. They focus on specific diagnoses, exclude complex cases, and often reduce therapy to a standardized protocol optimized for regulatory approval. State programs serve people as they are, with messy histories, overlapping conditions, and non-binary outcomes. These are precisely the populations that make up real mental health need.

They also preserve the full therapeutic process – preparation, facilitation, and integration – in a structured care model that can be defined, costed, regulated, and evaluated over time. These are all critical prerequisites for gaining insurance and Medicaid reimbursement for care that goes beyond ‘drug plus brief supervision.’

The result is a rapidly growing body of evidence about what drives outcomes in psychedelic therapy. Not just whether a molecule works, but how specific components of care affect safety, durability, and real-world effectiveness.

In Oregon, Healing Advocacy Fund has partnered on research into psilocybin therapy for adults struggling with alcohol use disorder, with results expected in early 2026. Other studies are producing promising findings on depression in low-income, Medicaid-eligible clients and veterans, as well as brain scans suggesting the reversal of traumatic brain injuries among professional athletes. This real-world research complements clinical trial data, strengthening our understanding of psychedelic therapy’s applications.

This kind of evidence is essential. It informs standards of care, supports coverage and reimbursement decisions, and helps insurers and health systems understand how to integrate psychedelic therapy into behavioral health benefit structures rather than treating it as an exception.

The Coming Tension: Therapy vs. the Pharmaceutical Model

As federal momentum builds, a central tension is coming into focus. FDA approval will almost certainly arrive molecule-first, indication-specific, and framed through a pharmaceutical lens.

That pathway is not inherently wrong, but it is incomplete.

There is a real risk that psychedelic therapy becomes absorbed into a drug-only, disease-focused model that covers the molecule while stripping away the therapeutic context that many of us believe makes it safest and most effective. In that scenario, insurance may reimburse the molecule but not the care. Preparation and integration become optional add-ons. Access narrows to those who fit rigid diagnostic categories. The very features that make psychedelic therapy transformative could be sidelined.

State programs offer the strongest counterweight to this outcome.

They can provide real-world evidence about how outcomes are shaped by the therapeutic process, not just the compound. They demonstrate safety emerging from regulation, training, and preparation. And they show that people benefit even when they fall outside specific diagnoses.

As federal policymaking accelerates, these programs become more than access pathways. They become the evidence base, the policy reference point, and the leverage needed to argue for a whole-person approach.

State Programs as the Foundation for National Advocacy

Strong state programs alone will not guarantee a favorable national outcome. Even with compelling data, coordinated advocacy will still be required to shape coverage, standards, and reimbursement.

But these programs generate the data needed to challenge narrow coverage decisions and establish standards that can inform federal policy. They also elevate lived patient experience in a way no clinical trial ever could.

This is the infrastructure required to fight for insurance coverage of full care models, for equity and access, and for flexibility beyond strict diagnostic silos.

In this sense, state programs are not a detour from the FDA pathway. They are the scaffolding that will determine whether FDA approval leads to another pharmaceutical tool or to a transformative change in mental health treatment.

From Thousands Today to Millions Tomorrow

Thousands of people are being helped by state-regulated psychedelic therapy programs today. Not someday, not after federal approval, but now. Entirely new models of care are being tested, refined, and evaluated in public view.

The choices being made in the states about standards, outcomes, integration, and access will echo far beyond their borders. They will determine whether psychedelic therapy emerges as a holistic, person-centered model of care or is reduced to a narrowly reimbursed pharmaceutical product.

This revolution in psychedelic care isn’t waiting for FDA approval. It’s already underway in the states. The future of the field depends on defending, strengthening, and learning from these integrated, real-world models of care. The states are showing us what healing can look like, and what we choose to build on now will shape everything that follows.

Taylor West is executive director of Healing Advocacy Fund, a nonprofit that aims to support safe, high-quality, and accessible psychedelic therapy for all who can benefit. Founded in 2020, Healing Advocacy Fund works across the state-regulated psychedelics access programs on matters related to implementation and education.