Psychedelic therapy is often described in terms of the drug, the compound, the dose, the brain effects, the promise of a breakthrough for people who have not been helped by existing treatments.

But Heidi Allen thinks that framing leaves out the part that may matter the most, the therapeutic care model around the experience.

Not as an add on to the chemistry, not as something separate from the treatment itself, but as a clinical structure that helps determine whether a psychedelic experience becomes safe, meaningful, and durable care. That structure includes preparation before the session, screening and consent, support during the experience, integration afterward, ethical boundaries, and trained clinicians who know how to work with people in unusually vulnerable states.

At the Columbia School of Social Work, Heidi is helping build that clinical workforce.

Her training program asks what psychedelic assisted therapy should look like if it is going to move beyond boutique care and become part of real mental health systems.

In this conversation with Jay Walker, Heidi explains why psychedelics may open a window for change, why that window still needs therapeutic support, and why the field is now facing a difficult question.

As companies try to make psychedelic treatments easier for the FDA to evaluate, some are reducing the role of therapy in the protocols themselves. Heidi worries that this could shape not only what gets approved, but what insurers pay for, what clinicians are trained to provide, and what patients can actually access.

At the center of the conversation is a deceptively simple question.

If psychedelic therapy works through the relationship between biology, experience, and care, what happens when the system learns how to regulate the drug but not the therapeutic care model around it?

Jay Walker begins there with Heidi Allen.

Heidi, I’m glad you’re here. So looking forward to today’s conversation, I think a lot of people start off misunderstanding what it is you do. So what do people most often misunderstand when they hear psychedelic therapy?

Well, I think that most people understand what a psychedelic is, and I think that’s the therapy part that people find most confusing because there has been a number of regulatory pathways by which people have access to psychedelics, and some of them are not regulated, like underground use. And the language of healing and wellness and therapy have been kinda ubiquitously and intermittently applied to very different contacts. So ketamine is an FDA approved treatment for treatment resistant depression. Some people understand that you could go to a therapist’s office and you could get a ketamine in the context of therapy. Other people may go to a physician’s office and get ketamine outside of therapy purely as a medical, not behavioral intervention. Some people will talk about going to Mexico or Peru and experiencing these life changing impacts, what they describe as therapy. Underground ceremonies are often described as two years of therapy in one night.

The fact that people are confused is truly understandable.

So do people tend to get lost on thinking about the drug as opposed to the therapeutic process because there are so many different therapeutic processes?

Well, I mean, I think that one thing that confused a lot of people was the MDMA application that was put forward to the FDA with Lycos.

And that model really paired MDMA as a enhancer of therapy. So it wasn’t positioned as just this is a drug that, you know, we provide therapeutic support around, but it was around this is a drug that is gonna make therapy better. And so I think that that is the way that the ecosystem was framing it for a while. But when the FDA denied Lycos application, partly because they didn’t understand what to do with the therapeutic element of the protocol, they didn’t understand how to factor in, you know, over twenty four hours of two therapists combined with the medicine sessions, not even including all the therapy that happened before and after, then I think that the psychedelic drug companies started backing out of therapy very quickly to think of how could we produce an application to the FDA that is something that they will understand, and what they understand is drug trials.

They don’t understand therapy intervention trials. They don’t understand how to regulate therapy. And so that’s really moved us into this model of psychedelics in the context of psychological support. And we you know, I’m sure that this will come up again because this is a really important change.

And as these molecules get approved through the FDA, how they get approved, you know, the way that the protocols are conducted will have a huge implication on how they are implemented into routine clinical practice.

So when you talk about understanding sort of the therapeutic process, that’s one dimension of it. But there’s also understanding the mechanism of action itself.

What are the leading theories about why this is such an effective therapy in certain situations?

Yeah. It’s a very exciting field that is developing quickly.

There are a lot of very smart people using their scientific expertise to come at the problem. So that means that we have neuroimaging. We have psychologists doing social experiments in the lab. We have mice and other animal models. We have therapists. So there’s been an effort recently, I think, to really try to integrate those theories into something that brings evidence from all of those different scientific fields together. And I I think you can start with we believe psychedelics work because, one, when you ingest one of these molecules, it changes the brain.

And you can understand that the brain is highly efficient at keeping things out, you know, really helping you focus on what you need to think about and and taking everything else out of the equation so that you can function in the world.

And when you have people that have things like depression, anxiety, obsessive compulsive disorders, eating disorders, when they’ve been exposed to trauma, the brain becomes really centralized around those experiences and because they’re very salient experiences, and they’re experiences that could put you in danger. It’s similar to aging in that your brain becomes less flexible, becomes more rigid. We all know this as we get older. People get more set in their ways. They have their beliefs, and that’s really common. And in these mental health conditions, there’s this, like, looping that happens.

And what they believe happens is that psychedelics, when they’re ingested, that the parts of your brain that are usually in command telling you how to think and how to respond instantly, they become looser. And you have neurotransmitters that weren’t talking to each other talking to each other. You have new growth of neurotransmitters. You have releasing of neurotransmitters and the absorption in neurotransmitters.

And all of these brain changes create this window of opportunity that we’re not sure how long it lasts, but by which you can learn things in a way that you learn them when your brain was much younger, when it was much more flexible. Think about how a child learns languages so much easier than an adult. We have periods in our life where our brains are just really sponges. Right?

And they’re taking in everything. And then as they become more calcified, then it’s harder. And so it introduces this chaos, and all of a sudden, brain is making all these connections it hasn’t made. And as a result, with classic psychedelics, after the experience, you are in a position to what I think is benefit from therapy in a way that you may not have been able to benefit from before.

Or there is some evidence that the psychedelic itself can simply improve mental health outcomes. The brain is one major mechanism of change. And then the second is the more experiential element of it. The ability to access difficult emotions and memories from a place where you are more regulated, the ability to form deeper connections with your therapist where you’re more open, the ability to feel more self compassion and compassion for others, and essentially a way to change your story and change your narrative and think differently about yourself and others. A significant number of people experience awe or what they would term a religious or spiritual mystical experience, and that certainly could play a part as well.

So I not only have the experience of the psychedelic, whatever that is, but I have the experience of all my prior experiences, all my beliefs, my knowledge, my emotions, all of the things that I bring to the party are actually acting as part of a concert of all of my own subjective experiences is what I’m hearing you exactly right in that no two people are gonna have the same psychedelic experience.

They can take the same molecule. They can take it at the same dose. They can take it through the same route of administration, and every person’s experience is gonna be different. We do a lot of work in the therapeutic side to try to prepare people, and we often encourage them to set intentions for what they hope will happen during the psychedelic experience.

But anything can happen during the psychedelic experience, and we try to prepare them for that as well.

So walk us through then, when we’re talking about the psychedelic experience, sort of what psychedelic assisted therapy what does it look like in practice?

It has to happen in a team.

So you need a prescriber, and the prescriber is usually the person who’s responsible for doing a robust medical history to make sure that there are no reasons why a person should not be taking a psychedelic or addressing any things that need to be addressed, like maybe a person has been on an SSRI and they need to be weaned from the SSRI. Well, the medical provider would be the person who would lead that activity and screen and say, okay. At this point, a person is now ready for a psychedelic experience. And then the therapist would come in, and they would do a complete social history with the person, really try to understand kind of everything that’s happened to them that matters to them, why they’re there, what they’re hoping to get.

This is where the diagnostic part of the process happens. And, you know, is the treatment that they’re looking at the appropriate treatment for the diagnosis that they have? And then really educating the person about what the psychedelic experience might or might not be like, getting a history of if they have any prior history with psychedelics and what that was like for them. Really orienting them to everything that’s going to happen that day.

Doing their very best to prepare people for an experience that can be overwhelming. Helping them think about, we know, what are your coping skills when you feel overwhelmed? How can we resource you in the room? These are all part of the prep sessions.

And then the medicine session, depending on the molecule, can look really differently.

And in some medicines, people really go inward. They put on the eye shades. They listen to music. And for the therapist, it’s just watching them to see if you have any cues of any distress or anything that they might need from you. Other molecules like MDMA make people wanna talk. And so while they may have time in the eye shades, they may be encouraged to really, you know, go inward, it might be appropriate at some point for them to take the eye shades off and engage with the therapist. And that is where you would see the psychedelic therapy happening during the psychedelic experience.

Once the psychedelic experience is over, we start what we call integration, which means trying to make sense of what happened, trying to make sense of what it means if nothing happened. What if they’re disappointed? What if they had a bad experience? What if something scary came up?

Or if what if they had these beautiful insights, new ways of looking at things, new paradigms, new schemas? How could you take how they felt in the moment of the medicine and the way that they thought during the mode of the medicine, and how could you bring that into the reality of their everyday life and everyday relationships so that the effects that they have from the medicine are enduring, which would be, I think, a key indicator of success of psychedelic therapy is if after the medicine session, you see not just the rapid decline and symptoms of depression or anxiety, but you will see a persistence of that improvement over time.

So you’ve covered the screening and the safety elements.

Where does the ethical guidelines fit in, especially given the fact that, you know, you might have two people there and they’re all ready to go, and you suddenly get a sense that maybe this isn’t the right thing? How do ethical guidelines fit in here?

This is where it’s very important that people rely on their professional training and practice within the scope of their license, and they recognize when it’s an assessment that they need to make or when it’s an assessment that physician needs to make. Of course, the patient always has autonomy and should be providing informed consent.

But as psychedelics come into routine medical practice, there’s a whole set of ethical questions that need to be thought about and addressed a lot around the vulnerability of the patient in a non ordinary state of consciousness, but this isn’t the only environment where patients enter non ordinary states of consciousness and are vulnerable that happens every time somebody gets dental surgery or, you know, is is put under anesthesia. But there is this kind of real intimacy that can build between the clients and the therapist that can create some heightened risk for boundary violations or confusion around boundaries. And so I think it is really important that within every professional scope of practice that we think in the context of psychedelic assisted therapy, what additional guardrails should we put in place to make sure that this is safe for everybody who participates? And how do we respond to adverse events, which I think there’s still more work to do?

So you mentioned earlier about the differential here in how you deal with integration and sort of the psychedelic experience and getting it to be part of a longer term effect. This sounds very much like the question of the difference between psychedelics and sort of an ordinary medication, which might *** over time or might have an effect quickly to relieve a symptom.

Here, you’re in a very different operating theory. Can you distinguish how we think about this in a medical longer term context after an experience?

Yeah. So I think that there is a building consensus that post psychedelic session, there’s this window that opens up where therapy could be particularly efficient and effective.

And this was when I voiced my concern about moving to these psychological support models in the clinical trial, this is my worry. An analogy that comes to mind is a GLP one. A GLP one will help somebody lose weight. But if you really want to make a GLP one the most effective and efficient as possible, you will encourage the person to change the way they eat.

You will encourage them to do weight lifting so that they don’t lose muscle mass. You’ll put conditions in place to make that medicine, which is really expensive, as effective and durable as possible. And I think that the same is true with psychedelic assisted therapy. A person could have psychedelic assisted therapy, experience a rapid reduction in their symptoms, and then without therapy, it could pass pretty quickly, and they could be right back where they were before.

If you’re gonna invest, what will be a significant amount of money to have a patient undergoing a treatment that could last eight to ten hours that might require one or two health care professionals with them, that’s a substantial investment. You want that payoff to be as long as possible. And currently, we don’t actually have very good evidence at how long results last. But my intuition is the more that we can front load the therapeutic support and keep people engaging in therapy after the psychedelic experience, the better the person is able to integrate the experience, the more durability we’re gonna see of these results.

So you’re piloting the psychedelic assisted therapy training program inside the Columbia School of Social Work. So why did you choose to do it inside an academic environment as opposed to perhaps doing it on a stand alone basis or another basis where you wouldn’t have the academic structure around it?

There is a robust market of organizations that I I think have created really wonderful psychedelic assisted therapy programs for graduates. I focused on MSW students who are in their advanced clinical practice year for a number of reasons. One, these are people who are just entering in their field, and you can imagine that they’ve got thirty years of work ahead of them. So when they enter the workforce, that has a really long tail of impact.

Two, I wanted to lower the barrier, the financial barrier to entry into the field. Because the postgrad training programs, they run fifteen to thirty thousand dollars, and then some of them are molecule specific. So you do one program, and then you’re supposed to do another and another and another. That could become very expensive.

Specialty mental health as being one of the most difficult specialty services to access because there’s high demand and there’s a low number of providers. And that was my worry about what would happen with psychedelic assisted therapy. So I focused on social work because we are actually America’s number one mental health provider. When people say they’re going to see a counselor or a therapist, you know, I would guess, like, seven out of ten times, they’re going to see a clinical social worker.

And so if we don’t educate them, if we don’t prepare them, then that, of course, will leave a huge gap in the workforce and create significant access barriers. I also like the control that I have over their education and that I know what they’re learning about in their foundational year. And I can be really efficient and tailor the psychedelic assisted therapy element around the education that I know that they’re already receiving around the biopsychosocial model, around clinical practices, around social justice and equity. And then our students have to do six hundred hour practicums, and so they’re actually able to go out and work in these sites for their final year of study, which isn’t accessible to most postgrad training programs.

And, basically, I think that all of the interdisciplinary teams that will be touching psychedelics, which would be most mental health providers and a lot of physical health providers, need to have a basic understanding of what psychedelics are, what psychedelic therapy does, who it’s for, who it’s not for. And that really means bringing it into all of the schools. And I’m part of a organization called UPEP, University Psychedelic Education Program.

We are trying to train social work and nursing faculty, and then this year, we’re bringing in medical faculty to give them a basic education in psychedelic assisted therapy so that they can start bringing it into their school. So even if you are never gonna practice in psychedelic assisted therapy, but you’re a primary care doctor and you have a patient who tells you that they’re gonna go to Peru to do a retreat for their mental health, that you understand what they’re talking about and what they mean.

To make sure that the launch, it happens sometimes in the next few years, is safe and recognizing that people are already using a lot of psychedelics. And so we all need to be prepared, if nothing else, than from a harm reduction perspective.

So Heidi, you mentioned the FDA, who is the typical eight hundred pound gorilla in anything that is therapeutic in the United States. Obviously, FDA made an enormous amount of waves on the MDMA decisions they made, which then turned around and created a whole set of ripple effects with quote unquote companies in the psychedelic space. So how are the psychedelic companies reacting to the FDA’s latest set of changes, and how is the FDA overall shaping the psychedelic field as we look ahead in the next few years?

You very rapidly saw a retreat from models that emphasize therapy and a rebranding into psychological support, a reduction in the therapeutic support, so minimizing the number of prep sessions, really minimizing the amount of interaction that the therapist would have with the study participant during the medicine session, and then limiting the integration session. So that was the first response. And I think that they’re doing that to create a packet that the FDA will understand by removing this black box of therapy, and they’re hoping that will erase concerns that, you know, some people had about the therapy being unconventional. And then they wanna get their molecule passed because this has been an area where funding has primarily come from philanthropists and then venture capitalists, and people who are investing money to make money wanna know that it’s gonna actually clear the hurdle of FDA.

I worry that the protocol with psychological support will make its way into implementation similar to the way that Spravato, which is the nasal spray of ketamine, which passed the FDA without therapy, is implemented as a protocol in clinical settings without therapy. And I think that that would be a real disappointing outcome because I think that what we’ll see is we will still see an expensive intervention, but we will not see the same degree of clinical benefit for people who are really in need. And I don’t think we’ll see the same enduring impacts if we really scale back or completely remove therapy.

And when it’s not part of the clinical trial, then insurance companies are kind of left to say, well, why would we pay for therapy as part of this? It wasn’t part of the studies, and the studies demonstrated efficacy. So, like, let’s leave it here. There’s gotta be some way that we convince insurance companies that to get the bang for the buck that they wanna see from the clinical trials and real world implementation, that we have to take advantage of that period of time when clients are really able to do kind of hyper speed therapeutic work that has long lasting impact in that window, that we make sure that that gets paid for and supported.

So regulatory optics are driving sort of the financial corporate side that they just wanna do things that the FDA looks at and says, great. We’re good with this, as opposed to answering to a larger results oriented standard? Is that a fair way to think about it?

I think that they have a clinical threshold of success that they need to meet, and if they feel like they can clear that, they will keep it as simple as possible to clear that threshold.

And I think they’re banking on the research infrastructure of investigator initiated research that will take the molecule once it’s FDA approved and put it into different therapeutic contexts. And, hopefully, you know, when these molecules are approved and they’re rescheduled from schedule one, we will start to see the National Institutes of Health investing in the kind of research that would tell us what are the best therapeutic interventions to pair with these molecules for the best results.

The standard practice might start off being non therapeutically supported and evolve to a therapeutically supported practice is what many people are hoping if the FDA forces them into a non therapeutic starting point?

Well, I don’t have a crystal ball, but my guess is you will see it roll out in a variety of ways. You will see some clinics that will treat it just like an or IV ketamine clinic. It’s a medical procedure. You come in.

You meet with the nurse. You get the medicine. Somebody keeps an eye on you, you go home. And then there will be, of course, boutique clinics that will offer incredibly beautiful settings and, you know, robust therapeutic support, and they may or may not participate in insurance.

These may be self pay models, and that’s a real access and equity issue that we have to think about.

If you think about the future here for a minute, and you sort of say how big could this be, are we looking at a future where we unlock the consistent ability to go directly to the brain’s processing circuitry and learn more and more about the management manipulation and otherwise beneficial use of external molecules to deal with brain processing issues that are holding us back or clinically much worse. You know, is this a case where you see thirty years from now this could be a very common avenue?

I think yes, but it could take many forms. People could be taking medicines that have no psychedelic effect but build on the mechanisms that psychedelics have been working at. And so in those cases, you know, you could imagine widespread use. If it turns out that it reduces rigidity and increases neural flexibility, you don’t need to have a psychedelic experience to get some benefit from that.

I could still see people be interested. I think there’s a lot of medical conditions that hold promise. You know, there was a study for phantom limb pain. There’s studies on Lyme disease.

There’s studies on cluster headaches. And so I think that there’s a lot of medical application that we might see. And then I think it could become a first line treatment for a number of mental health conditions and for some really good reasons.

But all of that being said, I think that there is a limited number of people who want to have a psychedelic experience, even if they have been told by their provider that they could have benefit, I think that some people will readily say yes and that some people will never be comfortable with it as a treatment. And so I don’t think we should assume that if X number of people have a condition for which psychedelics are an effective treatment, that that X number of people would actually take psychedelics. I don’t think it will look like that.

So we need to temper expectations, it sounds like, at some level, to avoid the harm where people feel pressured that this is the preferred way to deal with some of their own issues, and yet they are not enthusiastic about this way at all?

Certainly, it should never be pushed on anybody, and it doesn’t work for everybody. All the clinical trials have shown that there’s a small but meaningful number of people for whom it isn’t effective, and there’s a small number of people in clinical trials who actually have bad experiences and wish that they hadn’t done it or have, you know, symptoms that persist for months at a time. And so we should tread cautiously, and we should just treat it as another important tool in the toolbox.

So there’s ultimately a risk profile, think of it as a negative side effects that all drugs have and all therapeutics have. And in the case of psychedelics, there is a risk profile that we’re beginning to understand, reasonably understand, understand well, where are we on that curve?

I think we need to understand better and more, and we will continue to have to learn what that looks like when psychedelics really are implemented into the real world, like for treatments PTSD. Some things that seem like a risk may not be as much of a risk when it’s in clinical practice. I think one real harm for the MDMA clinical trial participants was how abandoned they felt at the end of the study protocol when their therapist had to say, okay. That’s it.

We’re done working with you because this isn’t therapy. This is a clinical trial. And that produced a lot of harm. So I wouldn’t expect necessarily that harm to translate into the real world unless we create models that cut people off after they’ve had a psychedelic experience and started working with the therapist.

But there’s all sorts of risks in any new treatment that need to be carefully monitored and investigated in a a really systematic way.

Much tougher to do when you’re dealing with brains and you’re dealing with brain variation where even the same dose administered the same way, etcetera, has such a wide spectrum of possible outcomes makes it tougher to reduce that to a numeric risk profile, I would imagine.

Well, there’s some molecules that are riskier than others, but Oregon has done thousands and thousands of psilocybin sessions in this really not medical environment, regulated, but not a clinical environment.

More psilocybin sessions have been done in Oregon than in all the clinical trials combined, and they have had very few adverse events. Very few people have gone to the emergency department saying, I am struggling from this. And so I actually think for some of these molecules, the risk profile will look very good. While ketamine has a higher risk of addiction, it’s also been used safely in in babies and kids and adults in surgeries for, you know, a very long time.

So we know that risk profile really well. I think it’s very important that the regulatory boards in every single state know what psychedelic harm looks like. So if a patient or a client reaches out to them to say somebody harmed me, they will recognize the uniqueness of the psychedelic experience and be prepared to have a appropriate response. And I think that that’s work that really hasn’t started in earnest yet and needs to right away.

If you were advising policymakers, let’s say, on psychedelic regulations, one of those areas would be in recognition for what harm looks like. What might the others be?

I’m really hesitant to see us create a parallel regulatory system for providers, like separate credentialing, separate exams, separate educational requirements, because I think that you run the risk of people leaving one regulatory environment for the other. There are therapists who are facilitators in Oregon. They’re not able to practice under the scope of their license, so they’re practicing as coaches. And they’re learning, oh, well, I could just throw myself into the psychedelic world and kind of move away from the requirements that, you know, bind me to being a licensed clinical psychologist or a licensed clinical social worker. And I think that that’s really risky. And I think that asking people to do both to maintain their licensure and their profession and maintain a separate certification that has its own requirements and investments, I think, is a lot to ask for, particularly professions that aren’t super well paying like social work.

Let’s look out five to ten years here.

What would success look like if we were to demystify psychedelic therapies and we were to, you know, see a standard here that could really help the most people in a thoughtful way. What’s that look like?

Well, for me, it will not be a boutique system.

I would be devastated to see that this is like a cosmetic industry where people go to these boutique clinics and they pay out of pocket, and maybe the providers work out of network, but they don’t accept insurance, and there’s waterfalls and, you know, massages, and somebody comes by and does Reiki, and, you know, the whole thing costs ten thousand dollars. I would like to see this in emergency departments. Ketamine is a fast acting treatment for acute suicidal ideation. I would like to see it in inpatient psychiatry where currently these short inpatient psychiatric stays, the drug people turn to are antipsychotics, which are very **** ** the body and have really significant long term effects.

I would like to see it in treating postpartum mothers. I would like to see it in oncology clinics and in the VA and in substance use treatment. So that to me would be success because these molecules and these treatments have things to offer that we don’t currently have in our toolkit for treating mental health. We only have a couple of rapid acting agents, Tools that we can safely employ that have rapid benefit could be transformative.

People lose a lot when they’re suffering months and years of OCD or anxiety or depression.

And if we can help them feel better the day that they get treated, and we can find ways to keep that benefit going for a long period of time, and they won’t have to take it every day, and they won’t have to worry that if they stop taking it, that they will revert back to the way that they were before. This position many people are in with SSRIs where they take it during an acute episode of depression and they feel like they can never stop. You know, these are really transformative tools, and I would like to see them safely and equitably employed to all the people who need them and want to try them.

Well, that certainly is a worthwhile vision, and the sheer scale of the mental health challenges and the incredible limitations of the tools that are in the toolbox today, as you’ve pointed out, speak towards a world in which we need to be aggressive in looking options that are demonstrating efficacy and real change. My hope is that programs like yours, and especially passion like yours, become infectious in a good way.

Me too.

We can ultimately get to the root of how this could become a major category of therapeutic results that we can look back and say, that was a lot better than we thought.

I hope as well. Thank you so much. It’s been wonderful talking to you.

Good chatting, Heidi. Thanks so much.