Category: Core One Labs

Why is real world evidence important for psychedelic research and how do therapy and psychedelics work together? MAPS founder, Rick Doblin, and our CEO, Payton Nyquvest share their thoughts, our collaboration, and where our trial of MDMA for PTSD is headed. Moderated by Sharad Kharé of Human Biography.

Press release here

Full Dialogue Transcript

Sharad: First of all, thank you so much for making time, both of you, today. I believe there’s so much great work in this collaboration that we can talk about further in this dialogue. And I’ll start with you, actually. I remember being in an audience at TED and I got to watch your talk. And I knew of your work. I followed your work. But actually, I remember more glancing at everyone else, looking at you on stage, saying who’s into this right now? Who is fascinated by this conversation? And I remember you saying the words, he’ll inspire us and save us in your dialogue. And I felt like I had goosebumps because I thought, like, thank you for saying that we needed that to be said. And then at the end of your talk, everybody got up and gave you a standing ovation. Doesn’t happen all the time at TED, but when it does, everybody is celebrating together. And that’s what we’re doing here. We’re celebrating your great work. And I wanted to ask Payton, what was your first introduction to Rick and then how did that happen and what was your first impressions of this incredible character here?

Payton: Yeah, I actually and I don’t know if Rick would even remember this, but I met Rick at the same TED event, it was like an after party thing, that sort of a group that was holding after Rick’s talk. And Rick and I met there and I remember and that was very early. That was probably three… was that three? Three and a bit years ago. 2019 and I remember having a conversation with Rick and I was like, Yeah. Doing this and doing that. And I remember Rick, he had the look on his face like I was maybe a crazy person or something like that. And Rick and I regularly joked a few times about the fact that I’m probably still a crazy person, but it’s just being validated, maybe a little bit more than that back then. But that was the first time that Rick and I actually spoke. And obviously I’ve been watching the work that MAPS has been doing for a very long time and then really getting a much deeper understanding of it through Dr. Evan Wood and the BCSU.

Rick: Yeah, well, it’s so nice just to hear about the TED talk, because nothing has made me as nervous as that in many, many years of preparing for that TED talk.

Sharad: It’s an interesting audience. You know, it’s everyone is staring and looking and waiting…  but I remember, and thinking back, I remember you talking about MDMA and it says, you know, it can reduce the fear of difficult emotions. And I remember that quote and I wanted to talk about the study that this collaboration between Numinus and MAPS talking about this. And I want to just get deeper into that, actually. So can you tell me what is involved in the study and we’ll talk about it. MDMA for PTSD study. And we’re currently as and if you can, either of you maybe we’ll start with you, Rick. What is involved? Yeah, OK.

Rick: Well, the study is a study of more real world evidence, which has been talking about rather than a controlled study. So the particular partnership that we have is not about generating the data to get the drug approved directly as a medicine from Health Canada or from FDA or anywhere else, because there’s no control group. It’s an open label study. And the two main purposes of it are it’s the same design as we’re using it more or less in phase three. But the purpose is twofold. One is to train more therapists so that we will be working to have our therapy training team supervised by watching the videotapes of the therapy sessions. Then the other part is to get more safety data, which can be helpful because there’s no control group, the regular agencies won’t consider it to be efficacy data. So I think the advantage for us to working with Numinus is that we really want to lay the groundwork for once this becomes medicine, how does it actually get implemented? And then how do we get national healthcare like Health Canada to pay for the treatments? Because it’s definitely more expensive initially than giving somebody and SSRI or even giving them weekly therapy. You know, this is basically forty two hours of therapy and it’s with a two person team. So, the way in which some countries will decide to pay for it is are the effects durable and what’s the extent of the effect… And how does it work not just in these super, highly controlled settings. The other advantage of this project is that it’s a little bit broader, the inclusion criteria, so that we’ll be able to have more of this real world evidence that we have to be very narrow for the Phase 3 studies. So I think it’s really important. The other part is that because of a lot of efforts with drug policy reform in Canada, there may be a way that Health Canada might even go before FDA. I mean, we’re not sure about that, but that seems like a possibility with what they’ve been doing with compassionate use for psilocybin, for end of life and therapies, being able to use psilocybin as part of their training. So the other place I’ll just say that we’d like to expand a partnership with Numinus is this idea of giving MDMA to therapists as part of their training. And that’s something that we battled with the FDA recently and we’ve gotten permission, but they put on clinical hold a study for almost a year and a half for us to give MDMA to more therapists. We’ve already done it with over 90 therapists, tremendously effective. And we wanted a shorter study. And even though we got approval, it’s still expensive and a lot of data gathering. So there are going to be thousands of therapists in the US that we would like to give an MDMA session legally to, but the problem is the cost and therefore it may be a lot less expensive to do in Canada. And if so, once the border opens and everything is working, we could conceivably send thousands of therapists to Canada to work in a lower intensive protocol or even just consider it as part of. You could even say as part of whatever health Canada might be willing to do this as a very simple protocol, it would be less expensive for us to send thousands of people up to Canada than to do it ourselves in the US. So that’s another future part of the partnership that we hope to look forward to.

Sharad: It’s quite exciting. And Payton, could you talk more about Numinus’ side and this great work? Yeah.

Payton: Yeah, I you know, obviously echoing a lot of what Rick has just mentioned, and I think for us, you know, when we started Numinus, it was really how do we create accessibility for people? And, you know, now, as Rick, we were just joking about, you know, now people are talking about stock prices and raising money and all of these different kinds of things and and not to get distracted from the fact that that’s all wonderful if you’re focusing on accessibility for the people who really need access to to this treatment. And what I’ve really always loved about what the work that MAPS has been doing and their commitment to integrity is really around accessibility for people. And that’s something that I really enjoyed. And with Numinus, that’s been a big focus of ours as well. And, you know, the opportunities around the training of therapists is extremely important, not only to provide, I think, accessibility, but to keep the integrity and really make sure that you’re keeping a certain standard in regards to the people who are ultimately going to be the access providers for this therapy. Because while psychedelics show really encouraging promise, they’re tools and they need to be used with really, really well-trained practitioners who really know what they’re doing. And Rick and I have talked about this, too, but the importance of experiential based training is from just from my own personal experience, you know, it’s like you wouldn’t want to step into an airplane with someone who’s never flown the plane before. And I think it’s really important. And I think Canada, I agree with Rick. I think Canada is in a really unique position right now to really open up accessibility. And with this study, MAPS has done an absolutely hard to fathom job in getting MDMA to where it is today and through the FDA process. And for us to really commit to you know, I think we’re all in agreement that MDMA is going to become legally available. And what is seeming to be in shorter and shorter order. And, you know, there’s a lot of work to do and a lot of heavy lifting to do to build an accessible infrastructure for that to be able to fit into. You know, Rick and the work that MAPS has been doing, the last results from the Phase three trials are absolutely staggering results. And more and more people are reading those results. And if you can’t create accessibility for those, all of these people who are in desperate need of this treatment, you’re going to have a problem on your hands. And so there’s a lot of work that needs to be done by, you know, again, all these groups that are raising money and doing all the things that they’re doing to do the heavy lifting now, not the heavy lifting, MAPS has done a significant amount of the heavy lifting. But there’s more… There’s a lot of work to be done on a lot of our parts to do our part to provide accessibility for people and continue to help put some of these pieces together. So, you know, with this study, that’s where we see a really great opportunity.

Rick: Yeah. There’s two other points that make a partnership between Numinus and MAPS such a good natural fit. And so one of them and then you’ve talked about it a bunch, which is that you guys really have a therapeutic orientation.

Rick: Know it’s not so much maximizing money on your stock price. It’s really about treating people. And so there’s going to be pressure from national health insurance companies to minimize the amount of therapy as much as possible. And there may be costs of doing that in terms of patient outcomes, and so I feel that your therapeutic orientation will be such that you’ll be cautious about those things while also clinics that you’re trying to set up, things like that, that the more therapy you provide, the less drug people need, because then they can do the integration work. And so for us, it’s you are therapeutically oriented. You know, for us, we are manufacturing the MDMA, you know, will sell the MDMA by prescription. But I really like the fact that you guys are very therapeutically oriented. So I feel confident that there’s that sense of protecting the therapeutic intervention, even from pressures that come from insurance companies are now trying to weaken.

Rick: The other thing that I think makes such a good natural partnership is the drug policy reform orientation, particularly with Evan, where he’s seen so much of the harms of the drug war.

Rick: And so I think that in some companies, there’s kind of this what I think is the misunderstanding. There’s no way to prove it. But I think in a lot of the for profit companies, there’s a sense that they need to protect their business model from legalization, that once people can buy mushrooms legally at a store, why are they going to go and pay more for psilocybin or why would they go to a clinic? So I think that’s a real misunderstanding, because I think the more you destigmatize these things and the more you do that through both drug policy reform and medicalization, I think it will actually increase the number of people that want to go for trained professionals covered by insurance. And particularly those are going to be the people that have more complex problems. And not only that, they’re going to want to go to people that are cross-trained and have ketamine and MDMA and psilocybin.

Rick: And so I think this idea that Numinus sees drug policy reform as something important to be in parallel, not 10 years later with medicalization and also that it’s not about MDMA or psilocybin or ketamine, it’s about psychedelic therapy. You have that bigger vision. All these are why I think a partnership between MAPS and Numinus is such a good idea and such a natural fit.

Sharad: When I was going through the notes about all the work that’s going on, I read the words “Real World Study”. And can you talk to that and and tell me what that means from a layman aspect. What is a real world study?

Rick: Well, I’ll just start and then Payton, you can continue. But I’ll say that real world study is different from a controlled clinical trial. So just to say that we have probably 8:1 or 10:1 of people that contact us about being in the study and those that we can actually enroll because of all of the different inclusion and exclusion criteria that we have, that we have to, we have to be exceptionally cautious. For example, we exclude people with diabetes. That’s not really necessary. Loads of people with diabetes have taken MDMA, no problem. But there’s a slightly higher potential theoretical risk. So we have a narrow slice of the PTSD population. And we also have… we pay for everything. So there’s no patients, don’t have to pay for it. There’s no health insurance. So, real world means more like your average patient in the world so that you’ll be able to enroll a larger number of people, some of whom we would exclude. You know, there could be more safety monitoring necessary for certain people. But you’re gathering information that’s going to be about scaling this to the larger PTSD population. And then this idea that there’s no control group is the way that it’s going to be administered so that you may find that some people only want one session instead of everybody getting three. Some people may want two sessions. We can also have larger times between the sessions. So it’ll be more like what’s going to happen with real patients post approval, than it is in a rigid clinical trial the same for everybody.

Sharad: Payton, do you want to touch a bit on that from a Numinus standpoint.

Payton: Yeah, I mean, I don’t want to I, I think Rick said it much better than I have, but Ithink, you know, from Numinus’ side of things, what we want to establish is the real world help create the real world infrastructure. There’s lots of clinical trials going on. There’s lots of research on all different kinds of things. And I think for Numinus, our focus has really been on, again, going back to the comment around accessibility, what does this really, really look like at the end of the day? And ultimately I think that’s what’s going to make Numinus is successful, is we’re really focused on the client. We’re really focused on the person that is going to, in a real world context, come through the doors of a Numinus facility. And what does that look like and how can we do the best job for those people? And ultimately, I think that’s what’s going to make us successful. I think if we look at the space, you know, down the road, ultimately the groups that are really, really focused on client or patient outcomes are going to be successful. And and so I think with this study, it gives us the ability to continue to set that up. And again, Rick talked a lot about, you know, the very… what’s becoming the very short future of when MDMA is going to be available for people. And it is soon, even if it’s a couple of years from now – a couple of years is fast. And I’d love to hear Rick talk about this. But, you know, it must be amazing. MAPS has been doing this now for over thirty five years. To be able to actually say that we’re a couple of years out potentially is very short and there’s a lot of people struggling right now. We need a lot of help.

Rick: Yeah. Although I imagine that you may have heard of what they call the 80/20 rule, which is that you can get 80% of the progress with 20% of the work. And then the last 20% of the progress is 80% of the work they also use. That is, 80%of the people that use drugs don’t have problems, but most of the sales go to the 20% who either use a lot or some. But I, I am a little nervous about we have about declaring success too early because I think the next couple years are big challenges. And here in America, we have the example of the second George Bush president who after the initial invasion of Iraq, had went on an aircraft carrier and had a big mission accomplished flag the night before it turned into a quagmire. So, you know, this whole idea of celebrating. Yeah, the fact that it’s only a couple of years away is amazing to me after all these years. But I am very nervous about making sure we do everything that we can to to really get it approved. There’s something else I just want to add about the real world evidence, which is that you may find that for what, for example, that starting somebody off on ketamine before they do MDMA prepares them for MDMA. I don’t know that that’s true. But I’m just saying that as part of real world in these protocols, it’s not excluding everything else before and after. So there’s only just this one variable. You can start thinking, because we’re not really looking at efficacy, because it’s not a control group. So you can experiment now with different kinds of programs of treatment that could involve ketamine as well as MDMA in the same patient. And so you can learn a lot of things for the feel.

Payton: Yeah, and psilocybin as well…

Rick: yeah, you know, yeah, and the thing I think that will come in the future is and maybe I don’t know that you can do this is the combination of MDMA and psilocybin at the same time. People are talking. We hear a lot of reports about that. As a way for… either MDMA to be given first and then it sort of smooths out the social event or to give this, I prefer doing the hard part first, give the LSD or psilocybin first and a couple hours later MDMA to smooth the integration. But you’ve got the dissolution, the challenge unalloyed by the help you get from MDMA. So there’s all different things that need to be experimented with. And that’s where… what we mean about real world evidence.

Sharad: And what’s interesting to me. Rick, you’ve been in this, like this mindset for over 30 years and it’s great work. I want to talk about values alignment between Numinus and MAPS. And I think that’s so important to this conversation, because there’s many people that have come and tried to do such work or they’re working on this. But there’s something great about MAPS and Numinus and and this collaboration. If you can talk about values for both Payton and Rick. That would be great.

Rick: Well, I’ve talked about it in terms of being sympathetic and actively speaking favourably about drug policy reform. We’ve also talked about it in terms of really prioritizing therapeutic outcomes. I think that’s really important. And I would say that the even more fundamental one is to recognize what exactly we are going to do. Is this a treatment? That’s a drug treatment that sort of is minor, supplemented by preparation or so like the way as ketamine spravado is approved? Or is this fundamentally psychotherapy that the drug helps make more effective? And I think from the values perspective with Numinus is that you understand that it’s fundamentally therapy and it’s the therapeutic relationship that makes the outcomes so good.

And so I think it’s that sense, and while there is also this sense of for profit, I think that the other part of the value is really that we all recognize that you know that this is ultimately about helping people reduce suffering and that money can be made, but it’s not about putting money as the number one goal.

So, for example, when we talk about our goals are to treat a million people in the first 10 years after approval and train somewhere over thirty five thousand therapists. But we could also express that and we’re going to make X number of dollars from selling. But it’s like the patients first, then the money is important and it’s there. And that’s why you have investors who have given you these opportunities because they want a return. But it’s more about seeing that…. Well, the example is you can have all the money in the world and be on the Titanic and be going down with the ship that it’s about the whole world. And we’re in a major crisis with the sanity of the human race and the climate change and all these things. And so I think just Numinus has that value of what we’re really doing and what kind of a context are we in. And there’s kind of a spiritual element that I get from some of the Numinus people that’s really ideal.

Sharad: Peyton, talking about the amazing people, you know, and Devin Christie, you know, Evan Wood, all these incredible people that are part of this, you want to talk about them, Payton, and their role in this great company?

Payton: Yeah, yeah. I think just echoing so much of what Rick mentioned, values alignment, and, you know, especially, you know, the talking about the financial piece as well. If we continue to focus on the problem that we’re trying to solve and create solutions around, that ultimately, not only will you know financially that that will be successful, but also sustainable. Let’s not be shortsighted and just focus on what’s the best immediate bang for our buck sort of thing. And let’s think about what’s sustainable and what’s going to be really lasting for the long time. And that’s what we’ve been focused on. And ultimately, that does come down to people, the people that we have involved with and Numinus and the people that I see in MAPS just deeply, deeply understand that. And their commitment to the people that they’re trying to serve, I think is exceptional. And Devon, the work that she’s done to really and boldly – Right – these are people who have really stepped out within a health care system that these especially when when people like Devon were and obviously Rick and his team as well, it took a lot of courage and it took and to to boldly make those commitments. And it you know, from there’s certainly a personal alignment there, but it’s also what they felt was best for the people that they were trying to affect and help. And now MAP has the data to back that up through this Phase 3 work. And so I think, you know, again and then people like Evan, same sort of thing. For him to go out there and be a stand for the drug policy change that he believes is right and not only be a stand for it, but be effective in actually making changes. I mean, Evan has made astounding changes in regards to drug policy change. And he’s extremely passionate about it because he feels that’s what’s right. And so it sort of marrying this effectiveness with real integrity and focusing on the people first. So that continues to be my motivation for getting out of bed every morning and doing this is – just the amazing people and their ability to to really move these categories forward.

Rick: And I would say because of this kind of values alignment, I think this is going to just be the first of many partnerships that we have together.

Rick: As I’ve already mentioned, this idea of training therapists, I mean, that’s going to be a big one, but there can be a lot more as well. Other indications of MDMA that we could be looking at together or MDMA in combination of things or, you know, particularly Evan having done a lot of work with substance abuse. What can we do about MDMA for people whose trauma drives them to substance abuse? Right now we’ve had a challenging… again, OK, this gets to your question about real world evidence. So we have wanted to try to enroll people who are still active substance abusers, who maybe just been through detox or something. And but the FDA is not permitting us to do that, nor is Health Canada right at the moment. They want a certain period of time that’s been like 60 days or so. So in England then Ben Sessa did a study with MDMA, with alcoholics, and they were only out of detox a week or two. For some of these people, so I think one of the big areas that I’d really like to think about working together with Numinus on is working with people sort of, you could say dual diagnosis with active PTSD, but still potentially, you know, very brief time of after having some sort of detox or something so that they can or maybe not at all even. I mean, what could we do with ibogaine for opiate addiction? There’s a whole range of things that I look for that we can be doing together in partnership.

Payton: Just echoing on that as well – we have the substance use disorders studies that we’re doing with psilocybin at the end of the summer as well. And I, you know, I think there’s some really it’s very exciting to sort of see, you know, again, whether it’s with different medicines or what are some, again, going back to some of the real world work as is. How could we sort of leverage some of these different experiences and things to, again, really focus on the outcomes for poor patients?

Sharad: This collaboration between MAPS and Numinus, Canada and the US sort of coming here. I want to talk about what does this mean for the world and what are the opportunities for the world to look at this? That’s what I want to start off here.

Rick: Yeah, OK. Well, I’ll say that the way we’re looking at it now is that because we have intentionally taken on a globalization perspective, our first phase three study for FDA could have been all done just in sites in the United States and we could have gotten approval that way. But we’ve chosen to add sites in Canada and in Israel so that everything that we do for FDA is both for Ministry of Health in Canada and I mean Health Canada and Ministry of Health in Israel. What we’ve also been told is that if we can get approval from. FDA, Health Canada, Ministry of Health and also from the European Medicines Agency, which is now we’re starting to do that in Europe, that virtually every country in the world will then accept the drug without additional research done in those countries. The notable exceptions are China, Japan and Russia. Russia being a country that’s blocking all sorts of research, anything with schedule one drugs. China also is problematic, but they want it in Japan. They feel that they’re so unique genetically that they want phase three studies done in their own population, even though they’ll take foreign data. So I think what it means for the world is that people look at the FDA, Health Canada, Ministry of Health in Israel as leading organizations with the scientific capabilities and established regulatory systems so that if it does get approval in these areas, that in these countries, many countries will automatically even without him. So let’s just say that if we have FDA, Health Canada, the Ministry of Health in Israel, most countries of the world will approve based on that. And so I think that what it means for the world is that what we’re talking about is MDMA-Assisted therapy for PTSD is the first in class of psychedelic assisted psychotherapy. And so once you have the first in class of anything that really opens the door for a lot more innovation and other people doing research and other people trying to improve on things. And so what I think it means for the world is and what we see now is that the success that MAPS had them sort of addressing a lot of the regulatory problems that have blocked research, addressing overcoming some of the financial problems that we’ve had to do through donations and then getting this initial evidence. It’s helped build this entire for profit system of hundreds now for profit companies. So I think that’s one thing. But if we actually succeed in getting regulatory approval, then it’s going to open the door all over the world for more research, for more approval, for more patients. And when we talk about it in the US, just to talk about it this way, in the US, Canada and Israel, there’s somewhere in the neighborhood of 10 million patients. But in the world there’s at least three hundred fifty million or way more PTSD patients. So that’s what it means for the world, is that we’ll be able to use this as a launching pad to globalize.

Sharad: Wow, I look at what’s going on in Texas, California, Oregon, the decriminalization of psychedelics, and what does that mean to this work as well?

Rick: Well, first off, it means that the zeal for the drug war, which has been the primary motivation to block psychedelic research. It’s both the zeal for the drug war and also the concern about the counterculture. It’s political reasons. What happens when people realize that there’s a world beyond their own little selves and that people that look differently from them or have a different religion are really like 99.9% the same. What is it that the implications are from those kind of experiences? And I think they’re really profound.

Sharad: It’s beautiful work. I want to ask you about some sort of conclusion, you know, when you think about this work… What does the future look like for us? What is this new paradigm shift and wellness? That’s what I’ve been calling it, the psychedelic revolution, which I’m quite apt to like looking at and seeing it happen right in front of us right now. What does this mean for the future?

Rick: OK, well, I mean, maybe maybe because I’m from a nonprofit context and then you have to be careful what you say Payton about not giving wrong impression. So I’ll be a little bit bolder. I’ll go first and then you can say what I think is going to happen is that we’re going to get approval in 2023, psilocybin in 2024, 2025. Something like that will then have roughly 5,000-10,000 psychedelic clinics set up in the United States, Europe, Europe. Approval we think will be a year behind in 2024. So let’s assume we have these 10,000 psychedelic clinics and 50,000 therapists and different places of the world that’s going to be changing public attitudes. And so I think in 2035 we’re going to move towards not just the decrim for the psychedelics, but legalization in a form that I’m calling license legalization. So  it’s not the libertarian dream of everybody can just get it, but it’s that you have a kind of a license to do drugs. And if you misbehave, you get punished and you might lose your license and you might have to go to education or something for a while and you get it again. But I think that’s 2035. And then with harm reduction, with honest drug education, I think by 2050 we can have a spiritualized humanity. And so it doesn’t require all 8, 10 billion people to be psychologically informed, you can have these kind of spiritual experiences in other ways, even without psychedelics. But I think that the pressures of the globalization, of the global struggles that we have, that’s one that’s my optimistic projection. Alternatively, we could see know a time of crisis, of people really crumbling under the fear and anxiety of millions of climate refugees and the rise of authoritarianism and the way democracy is under challenge all over. And so the hope is that through healing people’s traumas so that they and their depression, anxiety, so they can see the world more clearly and not be inhibited from acting and have hope and and also with ketamine, with psilocybin… that we’ll have enough of a kind of Spiritualized core that will steer the ocean liner of humanity away from the iceberg that sunk Titanic and into the glorious future. And so that’s my thought. And I think psychedelics can play a major role to that. And as I ended up my TED talk, you know, it’s a choice between the humanities, the crossroads between consciousness and catastrophe. Yes. So I think psychedelics are here to help consciousness prevail. And I think that the medical research on what we’re doing with Numinus is a key part of that, because that’s the leading edge of culture right now, is science and medicine.

Sharad: Thank you for your answer and Payton, I don’t want to leave you out of this final thought as well, what is this, the future for Numinus and your work?

Payton: Yeah, I would be boldly in raving agreement with Rick around the… I think psychedelics have this amazing potential to help heal a number of really the largest societal issues that we have today around mental health and then looking towards the future. What about when we start talking about mental wellness instead of just mental health? But what does mental wellness look like? We all go to the dentist twice a year, whether we have perfect teeth or not. So this opportunity for us to shift from, you know, yes, there’s a huge amount of suffering out there right now that we need to help alleviate, but also looking towards the future mental wellness. And as Rick said, to you know, we talk a lot about whole human health and that connection throughout that and globally and on a global scale. And I think Rick’s you know, I’ve always loved Rick’s ambition and focus on, you know, this is a global thing. And for us, it’s been very much the same. So I think the future and again, the future is not far away anymore. It feels like… I think it’s extremely exciting. And I just more than anything, I want to acknowledge the gratitude that I have for Rick and MAPS. And I’m always deeply honored and humbled to be able to have these conversations and for humans to be able to do our part and in moving this forward. So I’m very excited and very grateful.

Rick: Yeah, le me elaborate one point, which is I think that these clinics that I’ve talked about will initially be for patients. But one study that we’re trying to fundraise for and complete would take place in Toronto. It’s called Cognitive Behavioral Conjoint Therapy for PTSD. And it’s where conjoint means couples are dyads, where one person has PTSD, but it affects the relationship and both people come into the therapy. And so we’ve actually done a small treatment development study where both people get MDMA, the PTSD patient and the person that’s impacted by that patient. And the results were better than anything ever done before with cognitive behavioral therapy. So what I mean to say, though, is that the clinics will initially be for patients, but they will expand and not very long time to family members. If you’re dealing with somebody that’s dying of whatever and you’re working with them with anxiety or depression, with psilocybin, what about their family members? They need help. And so I think it will go from this initial patients then to their families, and then it will move towards then it’ll move towards healthy volunteers for this wellness that is talking about. And that’s what these clinics will then become and then will become sites of initiation, I think, to get a license…. the safest way would be go to these clinics and you have your first experience for free under supervision, paid for by taxes. And then you know what? You’re getting into the same way. You got to drive a car with somebody, you know, in the car from the driver’s license bureau watching you. And but you get a sense of what it is and then you can do it on your own. So I think that these clinics are really going to be both for patients and then broader for family members and then broaden for personal growth and initiation.

Rick: So I think the clinics that Numinus s is going to set up will become models for social development and social growth.

Sharad: I want to congratulate you, too, both on this beautiful collaboration, a feasibility study for MDMA and PTSD is one piece. But bringing you both together and having this conversation and sort of the mind share of everything that’s going on is so important to our humanity. And I wanted to thank you both for your time. I have so much love and respect for you both. So I have one last question. It’s more of a Sharard question, so I will ask it. I want to ask you what gives you both hope in this work?

Rick: I hear from people almost every day saying I took MDMA or I took psilocybin. And I feel a whole lot better. I mean, so I initially got hope, of course, for my own psychedelic experiences. And that’s what really helped me persist through all of this. When the government of the United States was trying to make it out that one dose of MDMA caused serious brain damage and that you would have major functional consequences. And when a lot of people believe that and when regulatory agencies use that to shut down research for a long time, what gave me hope was that I knew that it worked. I saw it directly. And so I think what gives me hope now is these stories of healing, but also the more stories that are told. So the way you talk about being the storyteller. I think that while the regulatory agencies relate to data and they don’t really want to hear individual stories, the vast majority of people respond to stories, not so much to data. So I think this idea that as we do more and more research and as drug policy reform moves in, more and more people are coming out of the psychedelic closet. It’s those stories that give me the most hope.

Sharad: Well, it’s beautiful. Payton, what gives you hope?

Payton: Yeah, again, you know, I was fortunate enough to have my life saved by psychedelic therapy and being in a place where it was very much life or death for me. So, you know, again, resonated with what Rick said, our own personal hope. And then, you know, I was so shocked and astounded when I first started Numinus, the amount of people that were reaching out daily and still to this day happens. You know, as Rick said, MDMA therapy saved my life. Psilocybin therapy saved my life or saved the life of a loved one that I have that continues to give me hope. And I would say, you know, the other part of that is just how excited and how well adopted I see the medical community stepping into this space and how excited it seems that the medical community is as well for these different. Tools, again, go back to the training of therapists. This is really, from what I see, being seen as the next big revolution and paradigm shift in health care, and that’s being recognized by the health care community, not by the advocates that are trying to push it in a certain direction. It’s really, you know, change from within the system. And I think that for me is extremely, extremely exciting. And, you know, now to see this, as we’ve talked a lot about, really looking like it’s right around the corner is extremely exciting. And, yeah, it’s time.

Sharad: It is time. Thank you so much to both of you. I appreciate your energy, your time, your knowledge. And this is going to change the world and you are changing the world. And I like to be a part of it.