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Once people learn how to process trauma, it doesn't have to be overwhelming that they don't have to shut it down, that they can actually grow from the trauma we're teaching them to help heal themselves.

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Maps is a 501 c three nonprofit that researches and creates protocols for the safe use of psychedelics and marijuana in the hands of trained practitioners. Mattes has been working for decades to help make MDMA assisted psychotherapy for PTSD treatment legalized by the FDA. Right now, they're in phase three of the clinical trials. In those trials, at least 90 percent of results are statistically significant, showing improvements in PTSD symptoms after the MDMA assisted treatments. The Phase three trials are the last trials in the FDA's drug approval process, and the FDA could approve the treatment as early as twenty twenty two.

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Rick and Maps are undertaking an ambitious plan to make MDMA assisted psychotherapy into an FDA approved prescription treatment by twenty twenty three. So if you're a listener of any of our podcasts from Michigan, then you might have heard my story. I'm a military veteran who has suffered from complex PTSD for a long time. And earlier this year I sought out the help and I went through MDMA, assisted psychotherapy for PTSD. That mirrors the maps protocol. It works. So in short, it's become this radical process of healing for myself and those that I love.

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And I was really excited to talk to Rick today to hear where Maps is at with this critical work, specifically as it relates to the Veterans Affairs Administration and the future of this movement. So why does this movement matter? Well, because we see the news. Health care is in trouble. We have soaring costs, a pandemic. We have PTSD amongst our first responders and veterans. And meanwhile, we have an opioid crisis that is affecting nearly every American in the U.S. one in five adults, that's around forty three point eight million people experience mental illness in any given year.

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And one in twenty five adults, nine point eight million people experience a serious mental illness that interferes with or limits their ability to function. Scientists have gathered billions of data points about mental illness and how it affects us. And yet the fight for mental health is ongoing. The quest for new medicines that show efficacious and safe results is growing. What if the best medicine for these challenges is hidden in plain sight? Let's jump into today's episode with Rick Doblin, the founder and the executive director of Maps Drug.

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And as a side note, please note, we are not doctors or attorneys. This is not medical advice or counsel. These are serious subjects and substances. So please consult your own medical provider before making any decisions.

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This season of Hidden in Plain Sight is brought to you exclusively by our friends at Splunk. The Data to Everything platform Splunk helps organizations worldwide turn data into doing its time for data to be more than a record of what happened.

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It's time to make things happen.

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Learn more at Splunk Dotcom or by clicking the link in our show NUT's. Rick, welcome to the show. Yeah, Ted, thank you so much for having me. I'm really glad to be talking to you today right back at you. So our listeners are familiar with maps, dawg, and I am so excited to be hosting you today. There's a lot of exciting news going on. You just mentioned something about the VA.

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I would love for you to just take it away starting in nineteen ninety. So I started back in nineteen eighty six and I at that time knew that there was a lot of Vietnam vets that were still suffering from PTSD. And so I started trying to interest the VA in conducting MDMA research that we would pay for. We weren't having even asking them to pay for it. And the story was that the psychiatrists and therapists that work with events that are still suffering know that they needed something new.

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But it always went up to the political leadership and then it was squashed. And so every five years or so, we would try at a different VA and a different part of the country with new psychiatrists and therapists. And it would always be squashed politically. But about 10 years ago, I started working with Richard Rockefeller, who was the Dr. David Rockefeller was his father. He was the chairman of the Board of Advisors of Doctors Without Borders, and he was involved with the war in Kosovo and Serbia and all these refugees there.

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And he said what is he knew that they needed something more to help all those traumatised people. And he started looking at MDMA and then he said, what is your hardest problem? I want to help you. And I said, it's the VA. They have the natural interest in this. They are paying disability payments. They have the responsibility, the resources. And they should be doing this, but they're not because it's MDMA. And so Richard said coincidentally, his cousin was Senator Jay Rockefeller from West Virginia on the Senate Veterans Affairs Committee.

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And so Jay and Richard started working with us and we ended up. Having meetings up and down the Department of Defense and the Veterans Administration with the secretary of the VA, with the assistant secretary of defense for health affairs, secretary of the Navy, Navy surgeon general, all of these things. And the decision was made about six years ago, six and a half years ago, that they would permit us to fund a study with a woman named Candace Monson, who had developed what's called cognitive behavioral conjoint therapy conjoint, meaning couples where one person has PTSD and it affects the relationship.

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And she'd been deputy director of the Boston VA, but we had to pay for the study. It was done outside the VA and the VA would not refer any people to it, but the results were excellent. And so over time, we've been interesting more and more people. And what I can also add is that we're working with the Loma Linda VA with some researchers there, and the FDA has approved their protocol and their local institutional review board. Ethics Committee has also approved the protocol.

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They're still waiting for approval and for the state of California has to approve it. But the big message is that we are very close to working inside a VA system with MDMA, assisted psychotherapy for PTSD. And it's been a 30 year odyssey to try to persuade the VA that this should be taking place. And I had an interesting conversation with a former secretary of the VA and he was saying that the VA is not known for innovation and he thought that they would be resisting this.

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He wasn't surprised that it's taken us so long to try to get the VA interested in it. But in September, two thousand and eighteen, there was one million thirty nine thousand veterans receiving disability payments for PTSD. Now, not all those were one hundred percent disabled by PTSD, all different percentages, but there was over a million. That's almost two years ago. And there's more now that were disabled in whole or in part with PTSD. And we estimate the VA has not put out the number, but we estimate that they pay something like 15 billion dollars a year in disability payments.

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So you could say the emotional costs of war are enormous and the financial costs are enormous. And a lot of these are young people. These disability payments will go on for 30 or 40 years or more. And so the VA has the most vested interest of any organization in America to be looking at new treatments for PTSD, particularly ones that the FDA has declared MDMA a breakthrough therapy for the treatment of PTSD. So we're hoping that we will be able to demonstrate to the satisfaction of the VA that this therapy helps and that they should be adopting it more widely, completely agree.

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And with the recent results in phase two and with phase three beginning here, what are the top line statistics that you feel best represent? What this medicine can do in terms of efficacious treatment of symptoms or completely removing symptoms after a couple of month follow up or in some cases a year follow up?

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Well, the only statistics that we have right now are from the phase two studies, and we conducted phase two studies in Israel, Switzerland, Canada and the United States. And it took us basically 16 years from around two thousand to twenty sixteen together, all the phase three data. So I'll describe the results. But first, I'll say that the treatment itself is roughly three and a half months long and it involves only three sessions with MDMA in each of these sessions, our daylong sessions at our sessions with a two person therapy team, in most cases a male female team.

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And in addition to the three day long MDMA sessions, people spend the night in the treatment center. We have another 12 90 minute non drug psychotherapy sessions. So we have roughly once a week, three sessions before the first MDMA session for building the therapeutic alliance as preparation for the first MDMA experience, giving the patient understanding what MDMA does, how the therapy might work, and and for the therapist to understand what the traumas were and how the patients are doing.

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And then after each MDMA session, we have three integrative sessions for 90 minutes. So the key part is that it's not just about taking the drug, it's after the experience. What do you do with those emotions, those knowledge's, those new understandings, and how do you integrate that into your life? So it's 12, 90 minute nondrug psychotherapy sessions and three day long sessions. And the control group is the therapy, which is quite a lot of therapy with inactive or low dose MDMA.

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It doesn't have therapeutic potential. And that's compared to the therapy with. Full active MDMA, what we needed to do, we thought, because MDMA is so controversial, is that we needed to work with the most difficult patients. So we said that we would work with only treatment resistant patients. This is patients that had already tried other methods to help with their PTSD and they hadn't worked. And we would work with chronic PTSD patients, which means they had PTSD at least six months and on average they were severe PTSD.

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And also, unlike most studies that are done with PTSD patients, we were willing to include patients that had already attempted suicide unsuccessfully. A lot of studies think that those groups of people are too dangerous to work with and they'll exclude people that have attempted suicide. But we felt that that would be ridiculous, that we needed to really work with the people that needed it the most.

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I think that's so cool. I just want to pause there a moment. Rick, what gave you the courage to kind of make that bold statement? Was it just your history with the medicine, your time doing research? What gave you as an organization the courage to make that statement?

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Well, I worked with a PTSD patient myself in nineteen eighty four who had attempted suicide in the past. And I saw how MDMA helps people process difficult emotions. And so it was our thought that even if they'd attempted suicide in the past, that if you can give people hope that something can be healing, even if it takes multiple sessions, that they were not likely to try to kill themselves during the therapy. The other part was we realized that in research you balance risks and benefits and PTSD has a higher rate of suicide.

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And so we felt that even if somebody did commit suicide, we would be looking at the balance of all the data, know how many people were helped versus how many people were not. And we see that with all sorts of cancer drugs, sometimes people die. So we felt that we could probably survive one situation of somebody actually committing suicide. But the other part is that we have all of the non drugs, psychotherapy that takes place, the 12 sessions, so that we're in close touch with people.

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It's not like just hear some MDMA will help you with the session and then you're on their own. So we felt that with the monitoring that we were doing with people and with what we knew about how the drug actually worked in a therapeutic setting and that we needed to work with the hardest cases just because of the stigma about psychedelics that felt like the only option and that we're so glad that we did do that. We have had one person attempt suicide in the study, and it turned out that that was a person in the placebo group that got the therapy without the active involvement.

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And so but I say basically, this is if you're going to try to help people who are suffering, you can't say, oh, the ones that are suffering the most we're not going to work with. All right. So the results what we showed then is that at the two month follow up. So first, I want to, I guess, clarify that after these three MDMA sessions, the goal is to make people not need drugs, that it's not like as a surprise that you take it every day for months or years or decades.

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The goal is intensive psychotherapy facilitated by the MDMA with the intention of completing a process sufficient so that people can learn how to keep healing on their own afterwards and that they're not needing to come back for more MDMA sessions. So again, we're non-profit pharma. We're not trying to sell the most MDMA. We're trying to get the best outcomes. And so what we showed is that at the two month follow up, after the last MDMA session and the reason we chose two months is that there could be concerns that there's like a psychedelic afterglow.

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If you take the MDMA, you'll feel better, but then it fades. And then after a couple of weeks, and that's what we see sometimes with ketamine, that ketamine for depression works. You need multiple sessions. It helps some people, but a bunch of people, actually, but it does tend to fade after one session. So we chose two months. So nobody could say this is the psychedelic afterglow that would suggest that it was durable. And the FDA said, OK, the two month follow up is what's called the primary outcome measure.

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That's the moment in time where what we're doing is comparing the control group with the experimental group so that the two month follow up, the people that got therapy without active MDMA or with completely inactive placebo. Twenty three percent. No longer had PTSD, so that's actually really good for therapy for this hardest group of people. But what we showed is with active MDMA at the two month follow up. Fifty six percent no longer had PTSD. So more than twice as good.

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And that that was remarkable. But the more important finding was that we looked at the 12 month follow up. Because what we really wanted to show, so the two month follow up is going to be whether the FDA will approve this as a treatment, but if we get it approved and insurance companies won't pay for it or the VA won't adopt it because they say it's too expensive, initially we really needed to show that it lasted even beyond the two months.

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And so the 12 month follow up showed that. Sixty eight percent. Two thirds no longer had PTSD, and of the one third that still had PTSD, most of them had had what's called clinically significant reductions of PTSD symptoms, meaning a noticeable improvement in their lives and in their functions. And if they could have had potentially a fourth session or they might have then no longer had PTSD. So what we showed is that once people learn how to process trauma, that it doesn't have to be overwhelming, that they don't have to shut it down, that they can actually grow from the trauma, that that would be tremendous.

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You know, that there's a process of self healing. And again, it's sort of different than for profit from it. We're trying to make people independent of MDMA, but independent of us, and we're teaching them to help heal themselves. And, you know, really, people have to do even if you set up a situation, a therapeutic situation, people are their own therapists. They have to heal themselves. You have to do the hard work.

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You have to be courageous, willing to do that. And so the data that we got, which was so promising from days to when we submitted to the FDA to go to phase three, the FDA said, yes, you can go to phase three. And then we negotiated for about eight months on the design of the Phase three studies. And we came to agreement with FDA. And that's a legal document, a written agreement in the special protocol assessment.

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So they must approve the drug if we get statistically significant evidence of an advocacy and no new safety problems arise. And once that was done in July of twenty seventeen, then in August of twenty seventeen, FDA declared MDMA a breakthrough therapy. So there's only been two drugs and I've got more data to share. So there's only been a few drugs that the FDA has declared breakthrough drugs, breakthrough therapies for PTSD, what is ours, which was MDMA and the other was repurposed sleeping pill from over 30 years ago called Tonn Myia and it was by TotEx Pharmaceuticals.

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And so we have then started our first phase three study. And actually about a week and a half ago, we finished the data gathering from our first of two Phase three studies and. Before the end of September, we're going to know if it was statistically significant, but what the FDA does is it permits the researchers to do what's called an interim analysis, and that's for what's called sample size re estimation. So when you design your phase three studies, you look at your phase two data, you look at your effect sizes and you decide whether what your assumptions are going to be for your statistical power calculations.

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And that's how you come up with a number of how big your Phase three study needs to be. But the FDA permits researchers to have a small group called a data monitoring committee that is unblinded, that looks at the data before the study is over. And if you're actual data is not as good as your hypothetical data, you can add more subjects to the study to get statistical significance, because the more subjects you have in the study, the easier it is to find statistical significance.

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And so sometimes you have extraordinarily large studies that can be statistically significant, but the effect size is actually small. But you can rule out chance with larger and larger numbers of subjects, so this time they have their interim analysis in February of this year and they were in phase three, they were breakthrough therapy and they learned that their study had failed and that there was no number of subjects, that it was worth it to add to their study and that they should just stop the research.

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And they had lost well over one hundred million dollars on the project. So we had our interim analysis in March, and I'm happy to say that we got the exact opposite results, 90 percent chance of statistically significant difference in PTSD symptoms after MDMA assisted psychotherapy.

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And that's I think in your words, you say that is what you dream about in the pharmaceutical development community. Yeah, it was really exciting.

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But then that was March and then we got covid and then things shut down. And so the FDA reached out to us, but also to a lot of other sponsors of research that were well along. And they said we're open to considering whether you want to end the study early. So we had agreed with FDA we would do two one hundred person phase three studies. And the interim analysis was conducted when 60 people had reached their primary outcome measure and we had enrolled a hundred, but enrolled some of them and not actually even started the first therapy.

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But when they passed the screening. So we negotiated with FDA that we would end with 90 people and instead of one hundred. So because we're ten people less than the interim analysis, we're not positive what the chances are that we're going to succeed. But we think it's very likely that we will succeed and get statistical significance and we'll know before the end of around the end of September. And we've started already the second phase three study. And we have two sites in Israel, two in Canada and 11 in the United States.

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And because of covid, we've got about five or six study sites that have started. Now, we hope by the end of the year we'll have about ten. We anticipate by middle of twenty, twenty two we should be engaged with FDA in what's called the NDA process, the new drug application process, assuming again, of course, that we get two statistically significant studies and we hope by the end of twenty twenty two or the early twenty, twenty three that we will have FDA approval.

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And as soon as you get FDA approval, is there any type of timeline or is there a vision there you can paint of what this looks like as it becomes available?

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Yeah, well, let me say that in addition to FDA approval, there's also a new thing that's happening called expanded access or compassionate use. And so what the FDA has created is options for people who have a disease, but that they can't get into the clinical trials and the clinical trials are promising then people can at their own risk because the subject, the study hasn't been completed. We don't have all the information at their own cost. They can have access to the treatment and they do it without a double blind condition.

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Everybody would get the MDMA therapy, but people have to pay for it themselves. And so we've negotiated with FDA that we are starting expanded access. They've approved fifty people for expanded access. We're setting up ten new sites in the United States. And we think that the first one will start sometime in October near Bethesda, Maryland. We're working with a military psychiatrist who's an expert in PTSD, who works at Walter Reed, and he's very interested in working with veterans and active duty soldiers with MDMA.

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He's going through our training program. So while we're working on phase three, we will also be working on expanded access. And the value of expanded access for us is twofold. First off, it's helping more people. But the main thing for us is that it's training new therapists. We have a very thorough training program for the therapists. You recently trained of the new ones, right?

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Yeah, that's for phase three. And we're training another 40 or so for Europe. We're trying to raise more money and move to Europe. And we've trained about another 30 or 40 for expanded access, but they're not fully trained. So the final part of the training is that we supervise therapists as they work with a new PTSD patient. And we can because it's MDMA is a scheduled drug. The only way that we can do that is inside a research project that's FDA approved, IRB approved, and then also DEA approved.

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And so expanded access is a really good opportunity to train more therapists. So the vision, though, is that. The treatment is not the drug, the treatment is the therapy enhanced by the drug, and so therefore, when we've already negotiated preliminary with the FDA, that the only people that can prescribe this and the only people who can actually train patients are people that have been through our training program and they can only administer it under direct supervision. So it's not going to be a take home drug.

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Sure. So the model is going to be clinics. And what we're finding, though, and I think this is a good thing, is that while we're talking about MDMA for PTSD, what we're really interested in is psychedelic psychotherapy. And what we find is that the therapists are also interested in that. So there'll be clinics that people will be able to go to and these therapists are eventually going to be cross trained and MDMA and ketamine and psilocybin. And so they'll be sort of customized treatments that people can get, you know, negotiating with their therapists for different disorders.

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So there will be, I think, at one point six or six thousand, ten thousand psychedelic clinics throughout the United States, which is a lot. There's about six thousand hospice centers right now in America where a different approach to death, where people are at some point, you just try to help people have a peaceful death. And that happens in these hospice centers. So every community that's large enough to have the hospice center would be large enough to have one or two psychedelic psychotherapy treatment centers and they'll be one hundred thousand therapists or so, something like that.

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And so at the same time as now, let me go a little bit broader here. What we believe and again, this is because we're a nonprofit pharma. We're not really trying to make it so people have to come to us. What we believe is that the drug war and prohibition is a fundamental violation of people's human rights to explore their own consciousness and that people should have access to these drugs after they've had some education, potentially after they've had one experience in one of these clinics under supervision.

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So we call it licensed legalization that like you need to demonstrate to a driver instructor that you know how to drive a car and then you get your driver's license, that you need to demonstrate that you know how to handle these drugs and that you take the an experience in one of these clinics and then you get a license to buy the drug on your own. So what we want to do is help people to heal themselves. With peer support, with understanding of how these drugs work, and so what we think will happen is that the most difficult cases will come to the clinics and otherwise we'll try to help people heal themselves without having to even get the MDMA from us or go through therapy.

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So I think what we're really anticipating is the mission that we have is mass mental health. Sure. And this is also preventative medicine. This is if you talk to people who have been through this, I know many people personally and then who have interacted with online who can attest to this as being the start of their healing process. In general, autoimmune disorders, challenges that they've had for decades sometimes seem to clear up in the months after MDMA, assisted psychotherapy.

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How do you react to a statement like that? And have you found the same thing?

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We have? And so the mind body connection is amazing and MDMA really opens it up. There's an expert in PTSD called Bessel Vanderbilt. The body keep score. Yeah, the body keeps the score. So what that means is that trauma is stored in the body. It can be. And so you can have irritable bowel syndrome or fibromyalgia or other kinds of things that potentially not in all cases, but in some cases when you work psychologically, you can have really important physiological healings.

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So I firmly believe that to be true. I've seen it happen. You've seen it happen yet. And that's going to be something that we are looking forward to researching in the future would be there's psychiatrists that we're working with very much wants to look at MDMA for fibromyalgia. MDMA also has a pain reduction effect. It's really remarkable in that we've worked with cancer patients who are in great pain and on opiates. And the MDMA combined with the opiates, give them better pain relief and the opiates make people sleepy and they're not really present.

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The MDMA helps wake them up. So there may be a lot to be learned just about an MDMA in pain, not only psychosomatic pain, but physical pain. That's especially with the opiate crisis, for sure. Yeah, for sure.

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So I think that there is so much for us to learn going forward that that I would say that right now. You know, we're in the midst of a psychedelic renaissance, there's more psychedelic research than at any time in the last 50 years. There's more publications about psychedelics than ever before, even in the sixties. It's just amazing. But I think that the next several decades are going to be remarkable for exploring the potential of psychedelics. And my mentor and the leading expert in psychedelic therapy and research as a doctor, Stanislav Grof, he's now eighty nine years old.

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He worked at Johns Hopkins. He worked at the in the Czech Republic from the 50s. He's been doing LSD research. But what he said is psychedelics are for the study of the mind, what the microscope is, the biology and the telescope is to astronomy. And I think that's really true, that the psychedelics, Stan, talks about LSD as a non-specific amplifier of the unconscious, that it brings things to the surface that would otherwise be hidden. Just the other day, I spoke to someone who went through MDMA therapy and remembered a sexual abuse situation that had been put out of her mind.

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Because it was so traumatic, it was kind of shocking for these memories to return. You just try to look in other directions. And so MDMA in many ways enhances memory, but it reduces the pain of the memories so that you can learn from them. There's a measure that we use in our study called post-traumatic growth inventory. I tend to be kind of interested to see what you think about this. I love the sound of it. Great. Great title.

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Yeah. It's possible that, you know, for people who survive trauma, you can grow and learn. It can help you re-evaluate your priorities. It can help you question what is your purpose in life? What do you want to do with your time? How do you want to live? So it's possible to be traumatized and then deal with the trauma and then in some cases grow from that experience. And so that's what we really are looking forward to, to seeing happen more and more.

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Yeah, and I think one of the big cultural trends that's going to allow this movement to continue is that there aren't nearly as many stigmas anymore. And I know that sounds maybe cliche, but it's been my experience that there are so many people that either know about this, have been through it or have had a lot of success in their life, whether it's from businesses or relationships that they heal or new relationships that they find. They attest that this experience was facilitated by this medicine.

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And I think we're finally getting to a place where people have incomes that are either drive by their own means or they're in small business and they can share this stuff freely without fear of being fired or having a boss think it's weird or something along those lines. So, Rick, I'd be curious to know, what's your take on this this kind of time of sharing where people are giving their own testimonials about this? Is this like a whole new thing?

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What's your take on it? When we look at one of the most successful social changes of the last several decades, it's gay rights and gay marriage. They've got a long way to go still. But what really made that happen was people coming out. And acknowledging that they were gay and that a lot of these were people that were respected by others, they kept their being gay hidden, and it was something that they were stigmatized, a shame. But but when this coming out process happened, that changed people's attitudes, because then they said it could be anybody.

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It could be somebody, a football player. It could all the stereotypes disappear. So I think what we're seeing with the sharing with psychedelics and the people willing to tell their stories is that that's like the coming out for the psychedelic community and that that's an extraordinarily necessary and positive phase of moving forward in this integration of psychedelics into the mainstream as something that's both legal and accepted and not stigmatized. And I think that what we've seen is that it does take a lot of courage for the initial people to do that.

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And often they do suffer negative consequences from it. But over time, that really changes. The other thing in the background I just want to mention is the drug policy reform, particularly with marijuana. And so what we've seen is that over the last basically twenty four years in nineteen ninety six was the first initiatives for medical marijuana in California and Arizona. And over time, as people see the benefits in controlled situations for medical purposes, that contrast with the propaganda that they've got about how these drugs have no benefits, there are only risks for marijuana use to be a party of tragedy.

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I saw an ad from the 70s about somebody who smoked marijuana for the first time and then killed the friend of his that gave it to him just during a murderous rage. So we've got this propaganda and fears that people have got from. You know, scientists and others funded by the government or from just people with a vested interest in prohibition. Private prisons, all that horrible stuff.

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And so the average testimonial of the a lot of folks that I know are they either have their own company or they're an executive at a company. And this is kind of something that just goes on. And it's not something that they necessarily talk about. But a lot of successful people experiment with cannabis and using that to on the weekends unwind. And again, this is something that some people cringe at. And then other people are like, yeah, of course, this goes on.

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So I think it's just all a matter, too, of who you interact with personally. And once you see the effects or the positive benefits and someone says, you know, hey, I'm doing great. The wheels didn't fall off. It's it's a whole new ballgame.

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It is. And then what we found with surveys is that those people that are in favor of the legalization of marijuana, the most important factor you would think is do they use marijuana themselves? But that's not the case. The most important predictor of whether somebody is in favor of the legalization of marijuana. Is if they know a medical marijuana patient, because then they have direct information from somebody that they know that they can trust and they trust their own perceptions and that makes them think and reach.

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So I think that what we will see is and this gets back to the picture of the future that you asked me to be that way to get approval from the FDA, I think psilocybin will be approved in twenty, twenty three and then we will have a decade or so of training, thousands and thousands of therapists and setting up hundreds and then eventually thousands of these psychedelic clinics. And I think by twenty, thirty five now, of course, that's 15 years from now, a long term plan.

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But for those of us who have children and judges, you talked about your children, the thing that's amazing is you think when they're little, they're going to be with you forever. And when they're 18 and they're off to college or they want to live on their own and know you look back and you think, where did that time go? So I think for me, one thing that I've learned is that 20 years is not that long, actually.

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And so when I think is twenty thirty five is the time that we're predicting that they'll be enough public support for moving to this licensed legalization situation with psychedelics. And then we can have more self healing. People can work on the treating themselves or if they want to, they can go to these clinics. And we will, I think shortly after approval will have insurance coverage because we we're going to be able to demonstrate that it's cost effective. There's an awful lot of stress that people with PTSD have, and that leads to all sorts of physical problems that cost a lot of money to treat.

[00:39:06]

So if you treat the PTSD, you're actually treating people's bodies and a lot of other ways and will eventually be saving insurance companies. A lot of money, healthier and happier people is great for everyone. So, Rick, if we look out at the future and I'm trying to see more of a path of how we get to six thousand, seven thousand treatment centers, do you feel like this profession of being a psychotherapist who embraces psychedelics, that it's time to celebrate this?

[00:39:35]

Is it a time to for these people who are doing the work to just come out and say, hey, I make a great living, I have a great life and I enjoy my work because it seems like to get to the six thousand, to get to the seven thousand, we really have to paint an image of what this lifestyle is like for the psychotherapist. Or do you agree?

[00:39:54]

I would say I don't think it's safe yet for underground therapists to come up out of the underground. Sure. But I think for those therapists that we are training that are working on our studies and the therapists that are going to be working with ketamine and the therapists that are working, there's over one hundred ketamine clinics in America right now. I don't know the actual number, but there's quite a few. There's actually a lot of therapies are being trained for this little sideburn studies.

[00:40:18]

So there will be more and more people who are legally protected that do need to talk about how it's working for them and what what their life is like and the kind of things that they see. One of the things that we find from the therapists that work on our studies, that's one of the hardest things for them, is that they work in the studies with MDMA. But then when they go back to their private practice, they don't have MDMA.

[00:40:47]

And now all of a sudden they're working with people that the pain is just too much and the progress is much slower. And just it's been very difficult for therapists who have seen more rapid progress and have seen people grow in the research to go back to their other patients and have to go back to relying just on psychotherapy. Now, some people don't need MDMA. Some people will get better with psychotherapy and some people won't get better with MDMA. It doesn't help anybody, I guess I should say, just a little bit about the risks in the sense that MDMA increases blood pressure and temperature, not in a significant way for the temperature.

[00:41:29]

So we've never had a body overheat or get hypothermia in a research setting, and not just for us, but there's been thousands of people taking MDMA in therapeutic settings in our research settings, and that's never happened. But occasionally you might hear that people take Ecstasy or Molly or MDMA at a party and they dance all night. They and they die from hypothermia. So that has happened. But we don't see that happening in the research setting. The other thing that has happened occasionally in a recreational setting is people have heard about hydrating and drinking water so that you don't overheat.

[00:42:02]

Sometimes people drink too much water. You know, a few people have died from that in our research settings. First off, we control fluid intake, but we don't use water. We usually use fruit juice or Gatorade or something with electrolytes. So I'd say that's. Big harm reduction message for people that if you are doing this on your own, some kind of fluids with electrolytes is better than just drinking water in terms of blood pressure. We do screen people for hypertension and then if they have hypertension, we ask them to get it controlled and then we do a stress test.

[00:42:35]

MDMA is not so substantial what it does to blood pressure. If you climb a couple of sets of stairs, usually you'll be you'll be fine. But that is a concern. There has been a lot of talk about neurotoxicity from MDMA, the opposite effect of MDMA on serotonin that was used for about 15 years to try to block research. We don't find any evidence of that in the research. Now, again, we're only giving MDMA a few times.

[00:43:03]

We're giving it in therapeutic settings, but it's roughly the same doses. So of our three sessions, the first session, we use 80 milligrams. And then after about two hours, we give half of that 40 milligrams and that increases the plateau sort of extends the plant. So it doesn't increase the intensity so much, but it just makes the whole thing longer because it's really remarkable to be in a situation where you're finally able to look at your trauma.

[00:43:35]

You've got the support. So that's how it turns into an eight hour session. The second session is one hundred and twenty milligrams, followed two hours later by 60 milligrams. And then the third session is discussion between therapists and patients, which was best. So you can kind of customize the doses for people. And those are not that different from what people use in recreational settings. But often people they'll do that same amount and four hours later they'll do more and four hours later they'll do more.

[00:44:03]

And four hours later, the more so we stop after the one supplemental session. That's it. Sure.

[00:44:08]

And, Rick, thanks so much for sharing all this and being generous with your time. I was hoping to talk to you as a final point about something that is more endogenously focused, which is just whole atrophic breath work. And so I know you're a student of breath work, and I'm just really curious about how everyone listening can kind of use this as an entry point or a safe place for exploration, where they say there is a lot of healing available.

[00:44:35]

So I would love to hear you just comment on how you found this and what you think it still offers people today.

[00:44:41]

It's a remarkably powerful technique. And I think one of the main lessons I get from it is that people have in the past said, oh, a psychedelic, it's a hallucination, it's a delusion. It's produced by the drug. But really, it's it's you're a human. Having this experience catalyzed by psychedelics, you're not having a psychedelic experience. And so the breath work really demonstrates that, that there's other ways to catalyze this. And these are deep inside our psyche.

[00:45:09]

And that, I guess as a warning, I'll say that humanity as a whole is not a self-destructive path. And we know that with the environmental destruction and the species extinctions and the climate change and the weapons of mass destruction and the rise of authoritarianism and stuff, and so we really need deep healing. And I think that this deep healing and deep spirituality and the sense of how we're all connected, it's kind of individual kind of thinking produces alienation, loneliness, a lot of problems.

[00:45:49]

So I think that we're at a time of challenge for humanity, for our species, maybe will be the one of the ones that go extinct, ninety nine point nine percent of all species that have ever come before. So we need to get on our toes. And I think the psychological healing with breath, work, with meditation, with psychedelics are really what we need now. I completely agree.

[00:46:09]

And especially coming out of this mass challenge, the existential risk that we've been through with covid that is psychologically traumatizing for many individuals. It feels like we're finally reaching kind of a tipping point where many people are going to be looking for answers that are not sending them back to the medical system again and again and again. Are there any things you see on the horizon, like health insurance companies really embracing the numbers of the savings that they could produce for them?

[00:46:37]

Any examples like that that you think could really help move the needle? Well, we have an incredible opiate overdose crisis. More people dying from overdoses than died in the entire Vietnam War every year. And ibogaine and other psychedelics can be helpful for addiction. I think it's really going to take people seeing other people grow. So the fact that you're. You having me on the fact that other people are speaking about the healing that they've received, that's going to be really what changes people's minds because, you know, with all this concern about fake news or propaganda or people aren't sure what to believe anymore, so they're just going to believe stories from people that they know.

[00:47:22]

For example, when I when I asked that question about financial healing, the Veterans Administration, if they're paying roughly 15 billion dollars a year on disability for PTSD, and then we can start doing some research inside the VA system and show that we can help people who had PTSD get over their disabilities, you know, that should make a big impact. I mean, sadly, a lot of people really are motivated by budgetary things more than anything else.

[00:47:50]

The cold fact of just facing some folks where they are, I think, is what's going to help us get the extra momentum needed. But, Rick, thank you so much for being on. It's really an honor to talk with you. I know that psychedelics or something that has really helped me and specifically MDMA, assisted psychotherapy helped save my life. So this is important work. But you should, of course, do your own homework. And this is not medical advice.

[00:48:15]

Rick, thanks so much for being generous with your time. Is there anything you would like to leave our listeners with?

[00:48:19]

Yeah, I would say the maps that our website has an enormous amount of information, and one of the things that we have on it is what's called the treatment manual, and that's how we describe what the therapeutic approaches. So if you go to the website, one of the menubar says research, you go to MDMA. It's down at the MDMA bottom of that page, the treatment manual. So I think that that would be really useful for people that are willing to learn more about how the therapy is conducted.

[00:48:50]

Fantastic. Rick, thanks so much. And to everyone listening. We'll see you next. A great chat. I'm Sophia Bush, and you've been listening to Hidden in Plain Sight from Mission Doug. This podcast is sponsored by our friends at Splunk, the data to Everything platform in today's data driven world. Every company, big or small, Newar old, is sitting on terabytes of unused, untapped and unknown data.

[00:49:19]

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[00:49:44]

Check it out. It's buncombe.