Perspectives on Psychedelic Research, Clinical Trials, and Continuing To Connect From The Heart

Manish Agrawal, MD, is the Co-founder and CEO of Sunstone Therapies, the leader in the delivery of psychedelic-assisted therapies in the medical setting. Dr. Agrawal brings an extensive academic, clinical, and research background and depth of experience to Sunstone that spans medicine, engineering, philosophy, and ethics. Driven by a deep interest in healing, Dr. Agrawal is particularly passionate about whole-person healing and the transformative potential of psychedelic therapies. Manish previously held the position of Co-director of Clinical Research at Maryland Oncology Hematology, where he dedicated 18 years to the care of cancer patients.

Dr. Agrawal completed his Residency in Internal Medicine at Georgetown University Medical Center, where he was also a Fellow in Health Care Research and Policy and Bioethics. He earned his MA in philosophy from Georgetown University and an MSc in clinical research from Duke University. He earned a Fellowship where he was appointed Chief Fellow at the National Cancer Institute, National Institutes of Health, and Hematology and Medical Oncology. He also completed a Fellowship in Bioethics at the National Institutes of Health Clinical Center and was the first fellow accepted into both fellowships.

Here’s a glimpse of what you’ll learn:

[3:00] Dr. Manish Agrawal, MD, talks about Sunstone Therapies’ pioneering work in psychedelic-assisted psychotherapy
[5:20] How to foster a sense of safety during psychedelic-assisted therapy sessions
[7:45] Dr. Agrawal’s transition from oncology to psychedelic-assisted therapy
[13:30] The research methodology and clinical trials for psychedelic-assisted therapy
[23:52] What are the limitations of psychedelic-assisted therapy research?
[30:37] Tips for providers to navigate the challenges of psychedelic therapy
[37:41] Balancing adverse and positive outcomes of psychedelic therapy
[40:22] How clinicians can become involved in psychedelic-assisted therapy training

In this episode…

Psychedelic-assisted therapy is revolutionizing the treatment of mental health conditions, but its integration into medical practice raises significant methodological and operational challenges. How can researchers develop rigorous protocols while addressing the unique demands of this innovative therapy?

Oncology specialist and researcher Dr. Manish Agrawal, MD, pioneers psychedelic-assisted therapy in clinical settings. Conventional clinical trials, focused on standard medical interventions, struggle to accommodate the multidimensional nature of therapy-assisted psychedelics. To navigate these challenges, Dr. Agrawal refined methodologies to integrate therapeutic preparation, ongoing support, and post-session integration into their protocols. Clinical approaches must emphasize patient safety and trust, which are critical for the profound emotional states induced by substances like psilocybin and ketamine. Additionally, trials should incorporate validated scales alongside qualitative insights to bridge the gap between scientific rigor and therapeutic nuance.

On today’s episode of Living Medicine, Dr. Sandy Newes hosts Dr. Manish Agrawal, MD, the Co-founder and CEO of Sunstone Therapies, to discuss clinical trials in psychedelic therapy research. Dr. Agrawal talks about balancing the risks and benefits of psychedelic-assisted psychotherapy, his transition from oncology to psychedelic therapy, and the limitations of this groundbreaking research.

Resources mentioned in this episode:

Quotable Moments:

“Our two deepest values are love and rigor. People should experience that but also feel the rigor of our process, with the patient at the center.”
“To get the most out of psychedelic therapy, you have to feel very safe and trust where you’re at.”
“You learn a certain approach, but also be open to its limits. Don’t make it fit; it’s just a stance.”
“I tell people, have good real-life skills and then bring that into psychedelic therapy more than being a psychedelic expert.”
“I like philosophy in real life. This is the best lab for those questions; you see humanity naked, unbridled.”

Action Steps:

Embrace a multidisciplinary approach: Integrate insights from medicine, therapy, and other fields such as philosophy and engineering. This broadens perspectives and helps practitioners develop a holistic understanding of psychedelic-assisted therapy.
Prioritize hands-on training and supervision: Engage in practical training under experienced mentors in the field of psychedelic therapy. This approach allows practitioners to gain firsthand experience and navigate the nuances of therapy that cannot be fully captured through didactic learning alone.
Focus on creating a therapeutic culture: Develop a clinic or practice environment rooted in core values such as love and rigor. This foundation ensures clients feel safe and supported throughout their therapeutic journey, addressing one of the main challenges in psychedelic therapy.
Adopt a beginner’s mindset: Approach each client and session with openness and without preconceived notions. This mindset encourages practitioners to explore the complexities of the human psyche beyond traditional diagnostic labels, fostering more effective and personalized care.
Engage in continuous self-reflection and awareness: Regularly evaluate personal biases and emotional responses to ensure they do not interfere with client care. This self-awareness is vital in navigating the personal and professional challenges that arise in psychedelic-assisted psychotherapy.

Sponsor for this episode…

This episode is brought to you by the Living Medicine Institute.

LMI is a training, resource, and membership program educating providers about the legal and safe use of psychedelic-assisted psychotherapy.

To learn more or participate, visit https://livingmedicineinstitute.com.

Episode Transcript

Intro 0:03

Welcome to the Living Medicine podcast where we talk about ethical medical use of psychedelic psychotherapy, teaching skills, examining the issues and interviewing interesting people. Now let’s start today’s show.

Dr. Sandy Newes 0:18

Hi everybody. My name is Dr. Sandy Newes and I am with the Living Medicine Institute, a training and content program for professionals interested in psychedelic assisted psychotherapy, specifically ketamine assisted psychotherapy. And we are sponsoring this podcast, and I am delighted to be with Dr. Manish Agrawal and I am delighted that you have chosen to honor me with with your presence and for being on this and I’m just really happy to have you here. So for those of you who don’t know, Manish is the co-founder and CEO of Sunstone Therapies, which, if you’re not aware, they are very much the leader in the delivery of psychedelic assisted psychotherapy in the medical setting. So they have really pioneered and kind of held and continued to carry the torch forward with psychedelic assisted psychotherapy research. Dr. Agrawal brings an extensive academic, clinical and research background and depth of experience to Sunstone, and what I just found out from Laura, his colleague, is that this spans medicine, engineering, philosophy and ethics, that he has many degrees and has been involved in many different efforts, that we’re all very lucky that he has taken that expertise and really applied this in this particular field. One of the things that that he says is that he’s driven by a really deep interest in healing, and that he’s passionate about whole person healing and the transformative potential of psychedelic therapies. He previously held the position of co director of clinical research at Maryland oncology hematology, where he dedicated 18 years to the care of cancer patients, and then has turned to psychedelic assisted psychotherapy. So as I said, I’m really honored, and I’m happy to have you here. So thank you so so much for this.

Dr. Manish Agrawal, MD 2:09

Thanks for inviting me. I’m looking forward to speaking with you.

Dr. Sandy Newes 2:12

Yeah, good. Well, thank you. So you know, my hope is that we just have this really be a conversation. I’m excited to have the chance to kind of pick your brain and understand a little bit more about Sunstone and how this all came to be, and, you know, some of the aspects of the research, and maybe we can talk a little bit about training, as I obviously have a vested interest in that. But yeah, so first of all, if you could tell us what is Sunstone, for those who don’t know, like many do, but, but, you know, a lot of our audience are not psychedelic people. They are people that are interested in this field and here to learn. So, you know, lots of us who are involved in the psychedelic field really are, you know, cheering you all on. But imagine somebody doesn’t know anything about what Sunstone is, is specifically within the psychedelic field. And you know, if you could just tell us what you all do,

Dr. Manish Agrawal, MD 3:00

sure, yeah. So we’re, as you said earlier, we’re setting the standards and setting, what does it look like to deliver psychedelics to therapy the medical setting? So it’s really a new specialty that’s being born out in medicine. So it’s not, it’s different than traditional psychiatry. I tell people, because most psychiatrists, you know, either it’s prescription medications or therapy, and this is much more extensive. It’s eight hours of treatment, there’s prep, there’s integration, there’s a multi disciplinary team, there’s a physician, a therapist, an MA, there’s labs, it’s medical and psychiatry. And so it’s it’s really a different type of care, and it’s a new paradigm. And so we’re really looking at all the aspects of that and what it takes operationally to run a center. What are the people that you need? Because this, like other I joke with people, as you know, probably doesn’t matter that other your surgeon, you get along with or not, as long as your gallbladder comes out, you’re good. But really, to get the most out of psychedelics therapy, you have to feel very safe, and you have to be able to trust where you’re at, and that starts with every part of the organization from the time that you so the website, the phone call to the therapist. It’s not just the therapy. And so it’s really moving. It’s a lot of different moving pieces, like, for one person, it could be 20 visits with four or five different providers. So how do you really juggle all that, where it feels seamless and so long winded? Way says, How do we do this? Well, with the patient at the center,

Dr. Sandy Newes 4:33

right? So mind, if I just kind of like take a little side journey on that one so you as, you know, founder and administrator and you know, holder of the model and the vision. How do we teach that? Like, how do you, you know how to, I mean, because you just, you know, in the first, like two minutes, you just hit what I think is such an important aspect. Act like the providers at every step of the way are holding these clients in this bubble of care and of trust, and we communicate with them on many levels. And so, you know, when you have as large of a system that you have, how do you work with that? How do you help create that safety?

Dr. Manish Agrawal, MD 5:18

I mean, it takes a lot of different aspects, but I would say that it starts, and people will be surprised that maybe I start with culture. And so our our two deepest values are love and rigor. That’s what we say. And so people should be able to come and experience that, but also feel the rigor of our process and and the patient is at the center of it. So if we keep coming back to that, and everything that we do, that we ask, that we create, doesn’t always meet those standards, but that’s what we’re striving for. And so if you keep that as the backbone of what you’re trying to do, then you end up shaping systems to form and support that, and then you hire people that believe in that believe in that vision. You create systems that do that, because you can’t micromanage each thing. So that has to undergird it. And if that’s not held all the way throughout and that’s not valued, you can’t do it. You can’t piece a button. People think you know one of a good friend of mine now, and George Kimball. He was a he started the Stanford design school, and is one of the first. It was the first design school, really, in the country. Now there’s lots of them. And so people say this place is amazing. They’d come in and say, look, what are you doing? And they’d see, like, his desk, and he had, like, a thing of Green M and M’s and a lamp, and they would go copy that as if that was it. And so, all

Dr. Sandy Newes 6:44

right, we got to get the green M and M, okay, are we good? Let’s do it. You can

Dr. Manish Agrawal, MD 6:48

say, like, oh, we use this website, or we use that software. It’s, yeah, it’s the other it’s the other thing underneath

Dr. Sandy Newes 6:53

it. Well, that’s interesting, because that’s really analogous to a discussion Signi and I were having earlier about, you know, what makes good ketamine assisted psychotherapy. And, you know, people think it’s the medicine, like, it’s the Green M and M’s, yeah, no, and that’s like, that’s, that’s just a tool. It’s just a tool, you know? So, yeah, well, and kind of along these lines with this work. So how did you switch from engineering into oncology and, you know, but, like, really, the switch from, you know, my understanding that you started this Oncology Center and the research associated with it, and then pivoted from that into taking that and then developing the psychedelic assisted psychotherapy piece, is that accurate? And if so, kind of, you know what drew you to that?

Dr. Manish Agrawal, MD 7:45

So to make a short story long, you know, I could start anywhere, but if I start in college. You know, when I started college, I wanted to study philosophy. And you know, my dad said I didn’t come to this country for you to be a philosopher, and so interesting. What do you want me to do? And he said, do engineering that way. No, you can get a job and you can do whatever you want. And but you know, even at that early age, I didn’t recognize that I was interested in questions of meaning and in essence, like what makes us human, what makes us tick? And so I did engineering, and I like problem solving, but then I didn’t really love engineering. And so, you know, my junior senior, I said, you know, I don’t think I want to be an engineer. And so then I thought, well, maybe I’ll do biomedical engineering. And so that led me into medicine, saying, well, I’ll do biomedical engineering. And so I went to med school, and then I said, Wow, I really like talking to patients. And that led into to medicine. And then I thought I was going to do cardiology. But then, when I was doing my rotations, I loved talking to patients and having meaningful conversations with them, rather than sort of superficial ones, and oncology did that more than any other specialty except for potentially psychiatry. But that’s old time psychiatry. The new time psychiatry wasn’t that sort of orientation. Psychiatry wasn’t meaningful conversations. And so that led me to oncology, and I loved oncology, you know, I really had great relationships with my patients. We talked about everyday life, but I got to know them in a way that those profoundly touching to me and to them. And then probably 1718, years, and I started getting burned out, because I saw that even though so many people were living longer and we were able to treat their disease, so much of their quality of life was determined by the inner state, by their mental health, and really didn’t do much about it. And so to close the door on patients and walk out of the room and knowing that you their life is sort of shattered, and their families, and you don’t give them a lot of tools, and they’re not a lot of great tools, um. Know, right? And that’s when I heard about psychedelics. I’ve never even heard about psychedelics. I didn’t even want to tell us I haven’t, no people experiment in college. I didn’t even drink in college. Never heard about psychedelics till I don’t know, six, seven years ago.

Dr. Sandy Newes 10:17

Can we just kind of take a moment of appreciation of that, because a lot of people think, like, Oh, everybody in psychedelics is like the psychonaut, and they’ve been doing it the whole time. Like, that’s just not factually true. No meaning. There’s a lot of space in this for professionals who this is brand new to. So I love that. Thank you for bringing that up

Dr. Manish Agrawal, MD 10:36

Absolutely. And I would even say not just come back to where I get into psychedelics. But along that though, I will say a plug in for there’s a lot of controversy in the field about like, do you need to have done psychedelics before you can be a therapist and and I’m not here to necessarily have that discussion, but I will say in training of therapists that we’ve done and people that we’ve seen, I’d much rather have a really good therapist who’s never done psychedelics than someone who’s done a lot of psychedelics and thinks they’ve seen God and now he’s ready to be a psychedelic therapist? Oh, for sure, I completely agree with that. And so I think I tell people to have good, real life skills, and then bring that into psychedelic therapy or into psychedelic work that more than sort of psychedelic expert asked me that question, but, you know, so then I heard about psychedelics, and I read about it, and I said, wow, they are talking about dealing with existential crises, and we don’t even talk about that oncology like, you know, go to oncology meetings, and all the abstracts are about chemo. Nobody talks about loss of eating, by

Dr. Sandy Newes 11:47

the way, right? Your quality of life is going to dramatically decline. Everything’s going to change, and you not survive this

Dr. Manish Agrawal, MD 11:53

elephant in the room. Says, Never talk like these people are like talking directly about it. So I went and became friends with Roland Griffis, and that’s another story I’ll come back to, but I bet that’s a good one. And so I ended up writing a study that got IRB and FDA approved and and told my group, I want to do this and raise money. And built out a space and started doing so. We did the first group study using psilocybin and cancer patients in the outpatient setting. Oh,

Dr. Sandy Newes 12:36

so you, you bridged those gaps. Yeah, cancer and your interest in, kind of the existential and the human and the suffering and the alleviating suffering component with the psychedelics. Yeah.

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