Rick Doblin details MAPS’ 35-year push to legalize MDMA for PTSD, citing $7M Phase II trials with 105 veterans and the VA’s $6B annual PTSD disability costs. The FDA blocked 960 grams of 1985-sourced MDMA due to missing GMP documentation—like aluminum foil use—while Doblin argues context (e.g., therapy, festivals) shapes outcomes more than the drug itself. Ayahuasca’s religious protections and marijuana’s pending DEA rescheduling highlight how science and politics clash over trauma treatments, with MAPS’ April 17th anniversary event marking a pivotal moment in psychedelic medicine’s fight for legitimacy. [Automatically generated summary]
Well, you guys are so important when it comes to the dialogue of psychedelics, because from an outsider, this is how I always viewed MAPS. MAPS is always like, oh, those are the actual really smart dudes who are into psychedelics, because there's so many wacky fuckers out there in the world of psychedelics, and they want to bring you crystals and talk to you about channeling, and I know a healer, and there's so much going on that's so crazy.
And then there was science.
And then there was people doing actual peer-reviewed studies.
There was actual scientists involved.
There was real data.
And you guys were pursuing it the right way.
And I was like, ooh, these guys are so important.
Because there's not a lot of people that...
That's one of the weird things about psychedelics.
You could tell people that you went out and drank whiskey until your feet went numb and you shit your pants and no one cares.
But if you tell people that you got together with some friends and you took a naturally occurring psychedelic drug and you explored your consciousness and you're so much happier now and you feel better about life and you're more optimistic, if you do that, you're some fucking wacky hippie druggie.
And so we've got this coming out, and we've looked at other social change movements like gay marriage and gay rights, and it comes from people coming out.
Because there are loads of smart people that do psychedelics or, you know, talented or emotionally wise.
And they just keep it quiet.
So people don't really know who in society has had these influences.
Yeah, and that's why we need this kind of coming out.
So we were having these global psychedelic dinners.
This is our 30th anniversary.
Actually, tomorrow is the 30th year that I started MAPS in 1986. And we're asking people to, in their own homes or with their friends, to invite people over and then have them tell stories of what psychedelics have meant to them or what their hopes are for psychedelic research.
Well, there's people that have done this before with conversations about death with dinner and drugs with dinner even.
So they try to promote conversations in safe places, but where people feel comfortable to really be more honest and they can open up.
And so it's kind of modeling on that.
And then it hopefully helps people to come out even more.
I mean, we even have like a Twitter, it's a hashtag psychedelics because.
And so people can write in and just say psychedelics matter to me because, you know, I'm more hopeful or I'm, you know, feeling that multi-generational trauma can be addressed.
Isn't that incredible that that is one of the best things for it is MDMA. One of the best things as far as getting over traumatic experiences is an illegal drug.
Yeah, and yet there's a carved out area that we've been able to make legal, which is the research area, and it's because science is the vehicle in our culture that we trust, more our religion than our religions, and so it felt like science and healing were the ways into the culture that was freaked out by psychedelics in the 60s,
and now because of these Crises we're in and also these tools that can be shown to be really helpful and that people have made lives out of them that it's not hurt them, it's helped them.
But people don't know it.
So that's where we think the research is helping people create a space where they can talk about it.
I think it's people are starting to understand the true nature of these things instead of the propaganda and they're doing it from people like yourself being really honest about their experiences and People like yourself even more importantly because there's not a lot of people like you that have actually gone out and pursued all the significant scientific data On psychedelics and the beneficial properties to it.
So that we can understand, like, we have this idea about a thing.
Forget it.
Put all your ideologies aside.
Whether you're right-wing or left-wing, we have an idea about a thing that's not correct.
And this idea about a thing is that there's a certain group of consciousness-adjusting substances that are for losers.
They're for dumb people.
They're for fools.
And don't you mess with those.
And everybody who does those is lazy and stinky.
There's a lot of people that automatically lock into that pattern of thinking.
That's their go-to for any drugs, anything that's not legal.
But yet those same people oftentimes will drink.
They have no problem doing that, and a lot of times they'll take pills, too, which is even more bananas.
Well, if you're talking about people that are smoking marijuana heavily, one of the things that I would say is that if you're smoking marijuana heavily, you're not going to do a whole lot of thinking.
You're going to zone the fuck out.
You're going to do a lot of zoning out.
And while sober people might be absorbing more information, you're probably off on a world of your own all day long.
That's not necessarily healthy.
I think all psychedelic drugs should be an enhancer, but they shouldn't be in replace of.
You shouldn't say...
I'm just going to be high from the moment I wake up to the moment I go to sleep every single day.
It makes sense, too, because I don't play basketball, but I play pool, and one similarity they share is that it's about touch and feel, and that touch and feel is way enhanced.
Smoking pot and playing you can like see things better you have a better sense of where the ball is going you have more sensitivity as far as how far it rolls yeah I used to play racquetball a lot and handball and a lot and sometimes I would play stoned and sometimes I when I was you you did have that deeper sense of being in the moment you were just one step instant more into the moment as and predicting and knowing and just But there was an unpredictability
about it.
So I could never really tell if I would play better or worse.
Well, that's probably why you play good, because you're never sure and you stayed on the edge.
You know, there's an ego-dissolving quality of any of these psychoactive substances, and I think that ego-dissolving quality gives you more space to move around with all your other focuses.
That's my theory about it, because I always felt like with jujitsu, you definitely feel better at jujitsu when you're high, and I was trying to figure out why.
Well, you also feel like Somehow or another, you feel more vulnerable, yet you do better.
Like you're more like kind of freaked out by any aggression or more trying to avoid any sort of conflict.
Yeah, although I think the idea we need to do is more move to performance tests rather than drug tests, and then that's really directly what you're concerned about, and then you leave people's behaviors to themselves, but you check their real performance, not these indicators or predictors.
Yeah, from my personal experience, there's a big difference between how you understand and operate under it as a Like, someone who's been smoking pot for, like, 15 years versus someone who's been smoking pot for, like, a week or a month or even a year.
Like, there's a difference in sometimes your ability to handle being really high.
Like, your anxiety takes hold of you because you're like, oh my god, and you start freaking out.
Then you can't drive, you can't do anything.
And then there's people that are just OGs.
Like that Action Bronson character.
Action Bronson came in here.
This motherfucker smoked like nine joints in the entire time he was here.
He just kept smoking.
I had to tap out.
I had to sit back and watch.
And he just never slowed down.
He kept going in.
He kept lighting that fucker up.
I'm like, this guy's insane.
But like a dude like that, that guy can handle being high.
He understands how to be high.
But for someone who's not really that experienced at it, man, especially in a car, it's not a good idea.
I think the bigger question is, if it's true, then what?
And that's what I've tried to look at.
And so for me, if it's true that there's aliens from here somewhere else that are here, what would I do differently in my life?
Do I really need to solve that mystery, which doesn't seem very compelling and doesn't seem likely, but I think it's a way to be connected to something broader.
I think other people have definitely thought this up.
That there's some sort of a connection between people that don't want to believe in religion.
I don't want to believe in any sort of ancient ideologies, but they desperately want some superior.
And so they reach out to the skies and some of them get fixated on the idea of maybe even they have been personally visited because it makes them more significant.
It gives their life a bit more meaning.
You know, you were chosen.
We're testing you.
We're trying you out.
Conveniently always while you're dreaming.
But trust me, dude, it's really happening.
You're not just sleeping and dreaming something crazy.
No, you are actually on a spaceship.
And so you get these people that are kind of delusional.
And when you look at the sheer, raw numbers of people in this country, and then you look at the UFO stories and go, how many of these people could be delusional?
Could it be all of them?
Could it be some of them?
Could it be most of them?
What's the real number?
And that was the cold hard thing that we got to on that sci-fi show.
Because it doesn't discount the possibility of, definitely not of extraterrestrial life, and definitely not of people being visited.
It's entirely possible that extraterrestrial life has visited Earth, observed dust, and there was a unique Unique moment where someone was there and witnessed it and maybe even was in contact with them and then they took off and they were gone and they never returned again that is entirely possible because that's entirely what we would do If we could just go from planet to planet, as dumb as we are now, if we could just go from planet to planet and do studies, fuck yeah we would do it!
And if we found an intelligent life form that was more primitive than us, like cave people, like some 2001 shit with the monolith, you know?
If we found something like that, you don't think we'd go say hi?
Of course we would say hi.
We would definitely say hi.
And then we'd jet back off at our fucking sleep machine off into the skies.
And she came to mediate during this MDMA experience, and it became clear that this was really for her.
Not so much for them, for them to show their 17-year-old, who was torn between the different cultures, that something about our culture we wanted what they had, or we saw and respected it.
And a lot happened, and it was wonderful in all different ways, and there were some important healings, but in the morning when we were going, this young woman uh was going to get back on her horse and she had 17 magazine whoa and was reading it and that's where i started figuring out that you know even out in the reservation in these protected cultures that
this globalization of ideas and internet and podcasts and people are being exposed to ideas that they wouldn't have normally been exposed to even in china i mean they're having to do so much to kind of censor stuff Yeah, there's an explosion of thinking and ideas going on right now.
And I think people are getting unsettled because things they had thought were true and rigid and part of their frameworks are different in other places.
Their language is like the coolest sounding language ever.
It's got that...
You know, there's like a sound to it.
Like, there's something to their accent that just...
I guess it's like we're programmed to think of Native Americans as like spiritual and authentic.
You know, there's like this sound to it.
Like, do you remember that scene with Clint Eastwood?
Was it the outlaw Josie Wales where he met that Indian chief and they got together and these are my words of life and also my words of death.
Do you remember that speech, Jamie?
Do you know what I'm talking about?
Dude, you gotta find that.
It's so powerful.
It's like one of my favorite moments in a movie.
I mean, those Clint Eastwood movies were all ridiculous, right?
Like, when you stop and look at it, they're all ridiculous.
But there was something to that genre, that spaghetti western genre, because It wasn't just that there were cool action movies, but it was cool action movies that were in some ways reminding you of how people lived just a hundred years ago.
Because these were all in the 1960s and 70s and shit, right?
Yeah, and I think if we can see that really we're all more in common than we have different and we can appreciate the differences rather than be fearful of them and that what we have in common is this fundamental sense of connection of being this web of life that really we're not virtually we're pretty similar to animals you know we're way close to people with different skin or different cultures to be able to see that that is
who we really are and that acting from that and trying to work on cooperative solutions and I think that if we can have lots of people having these direct experiences so that they can't be manipulated by politicians so it's about grounding this kind of globalization but comfort with the sense of connection that we're Able
to find these bonds that they do exist and that they can be built.
I think one of the things that we're seeing in this extreme oversensitivity that we're experiencing right now, this is like a really interesting time as far as like PC culture and what you can do and what you can't do and cultural appropriation.
I mean, people are going after people for cooking Mexican food that aren't Mexican.
Yeah, we're trying to call that guy cultural appropriation.
Yeah, what I was going to say, though, is that this oversensitivity is just...
It's a side effect of this expanded understanding.
And in this expanded understanding now...
All of the different things that are injustices in the world are being highlighted in a way that never been highlighted before.
So then people start going after them and then pushing the line further back.
And then they start looking for other slights that might be around.
You know, other...
Microaggressions.
Microaggressions.
Anything...
What is this?
White people with dreadlocks.
Justin Bieber adds fuel to the culture appropriation debate.
First of all, ladies and gentlemen, all you have to do is Google dreadlocks.
That's what I did.
And I found out that the fucking ancient Greeks were like the oldest people that wore dreadlocks.
They believe it might have come from the ancient Greeks.
Also, a lot of other cultures wore dreadlocks.
Vikings wore dreadlocks.
It's across the board with hair, folks.
Okay, this is not a black thing.
Not only that, that's not what cultural appropriation is.
Okay, that's just style.
What cultural appropriation is, is like, say if these Native Americans had a specific style of clothing that you, if you wore it, you were a shaman.
And you were a sacred person or you had a headdress that you wore during very intense spiritual ceremonies.
And someone just started wearing that for fun.
Someone thought it was cool to wear that for fun.
Well, then it becomes offensive and that's cultural appropriation.
Because these people have this...
Ritual, this very important sacred ritual, and this one part of that ritual, you are defacing, you're mocking it openly, and it's offensive to them, it hurts them.
And even that's arguable.
That's culture appropriation, and I agree that I think if someone has something that's sacred, like a headdress or something that they specifically wear, and then you walk around and wear it, that's kind of a dick move, right?
If you have to earn that.
It's like someone...
Yeah, it's like being a fake black belt or having a fake PhD or pretending that you went to Vietnam and you didn't.
There's a lot of those people out there, right?
They're all equally offensive.
But that's...
Cultural appropriation is not a white guy wearing dreadlocks.
It's just not, okay?
That's a kid who likes to wear his hair like that.
Who gives a fuck?
And the only reason why you give a fuck is because you've run out of things that are really important to care about in your life.
Because if you cared about really important shit, you would concentrate on that.
That is a massive distraction.
If a white kid with dreadlocks is gonna, you're gonna go out of your way to find anger in a white kid with dreadlocks.
Tearing them apart or that they're avoiding but would be better if they try to work on it and you know that word work is weird because work avoidance Doesn't just mean like actual work like working on your job.
It could be working on yourself You know, it could mean, like, there's a lot of people that get involved in wacky behavior because they also are addicted to cigarettes and maybe they drink too much.
So they start getting addicted to wacky behavior as well, not just as a side effect of the drugs, but also to distract them from dealing with the work.
They create dramas.
They create bullshit.
And almost like to drown out the nagging poking of all the shit you actually need to get done.
So then you just fucking tank your life again in this way.
It's a matter of what you tolerate from yourself, too.
That's a weird line in the sand that you've got to learn to draw if you want to actually get things done.
You've got to say, okay, now from 7 p.m.
to 9 p.m., I do this.
This is what I'm going to do.
I'm going to sit down.
We're going to work.
And you be the boss of yourself.
And then you sit down and you stare at that computer screen or you stare at the notebook and you do the writing that you were really trying to put off.
It's hard for people to do, though, because a lot of times your brain is very wishy-washy, and we savor our choices.
We savor our ability to open up our websites and just start going, oh, what's going on on dig.com today?
Oh, wow, that's crazy.
And the next thing you know, it's 45 minutes after you were supposed to start.
What really put me at ease was one professor when I was working on my dissertation at the Kennedy School at Harvard, and I just had this idea that you had to have it so good, you know, to be worthy.
And what I was doing, it just...
You know, it doesn't start that way.
So I had three professors, but I needed a fourth on my committee, and he was the academic dean.
He's terrific.
But I said to him, you know, should I, because you're so busy, should I just work through with the other professors and then just give it to you in the final phase just for you to read over?
And he said, no, give it to me in the junk phase, because that's when your comments are the most important.
I like tweeting because you only get 140 text characters.
Those 140 characters, I think that's good because it makes you economize, and it makes you edit, and it makes you a better joke writer in a lot of ways.
The actual...
Figuring out the slams and the punches in a joke.
I think you can get to them better when you learn how to say funny shit on Twitter.
Because you only have 140 characters.
That small amount of text in this little box and you've got to figure out a way to get your point across and hopefully be funny too.
Sometimes it's just stupid text to me.
Someone will say something really stupid, just so silly, and I just can't stop laughing.
I think it's interesting how tweets have a time where they work, too.
Something could have just happened in the news.
And then someone will have the perfectly timed, ridiculous tweet.
And, like, in that moment, like, that dude, like, cracked up the whole party of the world, you know?
Or that woman, or whoever the hell said it.
There's a lot of people that, like Jenny Johnson, who was in here.
She's become famous in a working comic from tweets, just from being funny on Twitter.
Well, we're in this stage of what I'm considering our major reality check of our 30 years of existence, and that's submitting the data from MDMA-assisted psychotherapy for PTSD, these Phase II studies that we've been working on for the last 15 years, and submitting that to, first off, to our FDA consultants and then to FDA about going to the next step.
About going from exploratory studies to studies that if they work, then you get approval as a prescription medicine, as a prescription treatment.
So we're bringing all of these data points that we've gotten.
Roughly, just in this bunch of studies, around $7 million studies, over 105 people, and what we're able to tell is a story about risk and a story about benefit for post-traumatic stress disorder from any cause with MDMA-assisted psychotherapy as compared to A placebo and also from the literature and working with people who have failed on other medications.
Yeah, there's so many variables and ranges of individual responses.
So there's these massive tables, statistical tables for sample size calculations that help you figure out On the basis of all these assumptions, how many people you need in this study to get statistically significant results.
There are support that we're getting that makes me very hopeful about our ability to raise the money for Phase 3. We think it's going to cost around $24 or $5 million.
Yeah, well, the consequences, if it works, is that then we can start setting up psychedelic psychotherapy clinics for MDMA for PTSD. We can start negotiating with the VA and the Department of Defense with their hundreds and Hundreds of thousands of dollars.
The enormous...
Last year was about $6 billion that the VA spent in disability payments for about 600,000 veterans that are disabled to some degree with PTSD. Just for PTSD? Just for PTSD, around $6 billion every year.
What we've been able to show what we say in this...
A group of 105 people is that, and this is PTSD for many cause, not just war, but childhood sexual abuse or rape or workplace accident, trauma of any kind, that a substantial percentage of these people can have significant improvement.
And how that's evaluated is, fortunately for us, there is a Independent rater administered scale for symptoms of PTSD. And it's called the CAPS, the Clinician Administered PTSD Scale.
It's the gold standard developed by the VA, used by the FDA to approve Zoloft and Paxil for PTSD. And it's just been revised from CAPS IV to CAPS V. So it's a work in progress over decades.
And so this is the objective scale.
And people do have to tell...
their story to an independent rater and the way that the independent rating system is going to be done is going to be a whole pool of them that are calibrated with each other inter-rater reliability and they know how to administer this and they're randomly assigned to what we think will be about two hundred and thirty people for one phase three study that's probably what we're going to be proposing And we need two of those studies, two large-scale Phase III studies.
And what we're going to have is these raters will be randomly assigned to one of the subjects, and they won't necessarily know, is this the one-year follow-up, the two-month follow-up that really is the primary outcome measure or the baseline?
So the independent raters are really important because for skeptical people in science, the double blind is a key development.
How you do an experiment, you shouldn't know the two conditions.
You shouldn't know which is the experimental one and which isn't because your biases might make you subtly see what you want to see.
So the idea has been these placebo-controlled double-blind studies.
But it's good in theory, but with a psychedelic drug, people tell if they've got a placebo that does nothing or a psychedelic drug.
It's a fundamental problem.
of this research and that's why these independent raters are even more important for people to have confidence in the results.
And what we've tried is a series of studies giving low-dose MDMA and comparing it to medium and full dose.
And so the idea we thought was that if people are confused about which dose they're getting, But then we can show a dose-response relationship, then that's the double-blind.
That's the solution to the double-blind problem, is that everybody knows they're getting MDMA, but they don't know what dose they're getting.
And so you have to show the people that get the higher dose do better than the people that get the lower dose.
And the people, patients might not know, therapists could be confused.
That's the ideal.
So that's what we are heading for.
And that's what we've spent the last 10 years or so researching with different low doses of MDMA, 25 milligrams, 30 milligrams, 40 milligrams, 75 milligrams, 100, and 125. And we would always have this possibility of half the initial dose administered one and a half to two and a half hours later to prolong the experience and make it an eight-hour therapy session.
So in order to train therapists, the best way to train therapists is to show here's videotapes of actual patients under MDMA, and this is how they're It's poetry.
It's symbolic poetry.
People talk in terms of imagery.
Because half the time their eyes are closed, listening to music, having just their own private experience.
The other half of the time, more or less, they're communicating with the therapists.
And it varies.
And there's no particular order of things.
So it's basically...
And this is what I felt with the Native Americans when we did MDMA with the...
in the peyote circle that they had these elaborate rituals that you know went through the whole night that were beautiful and filled with these rich symbols but then they went so they did some of their opening prayers and they want to know what we're gonna do and we didn't have anything it was like well we just sit around and somebody says it's kind of a more freeform it felt that we had like a poverty of ritual but also freedom To
explore like that.
And that's what we try to provide in this MDMA experience, that people have their unconscious as the guide.
And we're not the guide.
We're not steering them anywhere.
There's all these techniques we know.
We're not...
We're responding to this emergence of material that's been catalyzed by the relationship, the setting, and then the drug.
And we're supporting this emergence.
And different people will sometimes go to the trauma first, or not talk about it until the fifth hour, or they'll go to child experiences that were supportive to build strength, or they'll But often it's in the symbolic language and they're sort of telling themselves a story.
And that story can reorder the neural networks in the brain and de-emphasize activity in certain fear centers of the amygdala.
And can change how memories are stored.
We're just sending MDMA to Rockefeller University, where one of the leading scientists in anxiety is going to start some studies in animals, mice, rats, I'm not sure which, and trying to look at fear extinction and memory reconsolidation and how MDMA affects that.
It changes how the memory, every time you have a memory, you have to consolidate from different parts of your brain, then you re-consolidate the memory.
But it's a memory of a memory that you're retelling.
It's almost like if someone you know that had a story and they did something and they told it to you and then you tell your friends about that story, that how, hey, I know Bob's story.
Let me tell you Bob's story.
But you don't really know Bob's story because you only know it from him.
You know what I mean?
You weren't there when it happened.
And I think that's some of what happens with at least my memories.
As they get older and older, I'm like, this is a memory of a memory that I had.
You know what you guys should really do if you really want to prove the effectiveness of MDMA? You should go to worldstarhiphop.com and find all those people that got fucked up and give them ecstasy and see if it helps.
Because there's so many people that got Hunted in the head and thrown off a fucking building.
The idea of being able to better process trauma is universally appealing.
I think all of us have had bad moments in our life that you probably overcome, and you probably have some character because of those moments, but it would be nice if you had a full handle on how it makes you feel.
I think that's part of the muscles relaxing, that Part of your tension, or it's tense because of parts of your brain.
So that the way in which you can then have this full memory when you're feeling peaceful, and you're looking at it as if it's happened in the past, which it did.
So you finally have got this perspective on it.
This peace makes it so that you're not seeing it as happening right now.
Because you realize it's not happening right now.
And so you're creating this longer, different kind of memory storage of something that was clearly in the past, and it's connected now to this reflective, peaceful tone.
So when the memory is reconsolidated, The next time you call it, you get the incident, but you get the emotional tone of this peacefulness and that it's in the past.
And so you can do work within a period of minutes sometimes or hours of seeing a shift and looking at something differently and processing these traumatic memories.
It's rare, but one person was in our study and he dropped out after just one session.
He's like, and part of what he got, Tony Macy is his name, was one of the vets.
Part of what he got was that he had been telling himself that he was on opiates for pain, for injuries, but that he was starting to realize it was really more of an escapism and that he didn't need them and he didn't need drugs and he didn't need MDMA either.
And so he wouldn't qualify for PTSD at the two-month.
And then when it got closer to the one year, which is our last follow-up, he started...
Saying, well, you know, I'm still feeling pretty okay, but I think I could learn more from MDMA. Maybe can I have now some more of these sessions?
And we said, well, it's a rigid protocol.
You've dropped out.
But let's just wait and see if you even would qualify to be in the study, if you even have PTSD. So he did the 12-month follow-up, and he didn't have PT. He wouldn't even qualify to be in a study.
So that means everybody that comes, you've got to look at their data, even if they drop out or they lied to get in the study or they wouldn't have qualified or whatever it is.
Once you have enrolled somebody, that's the more conservative.
You just have to include everybody.
You can't just be picking the people that fulfill your treatment plan.
Happiness being such a crazy sort of unquantifiable thing, right?
That's what everybody wants.
Everybody wants some happiness.
And one of the things that MDMA does seem to provide a lot of people is relief from tension, which in a lot of ways Equals happiness.
I mean, universally, if you had to say, what is the one thing that people get from a drug called ecstasy?
It's you feel great, right?
You feel relief.
You feel comfortable.
Insecurities melt.
They just dissolve.
They don't exist anymore.
And you can approach people in this really weird, open way.
Where you're not constantly ready to judo whatever kind of bad shit they're sending your way.
So many people, when they communicate, they always have some sort of a wall up or some sort of a barrier between their real feelings and what they're projecting.
So that they can sort of figure out how to navigate this conversation with the least amount of social damage.
There's like a zen to some styles of communication, like this way of going through it.
With having the least amount of conflict in your life.
But if everybody was on ecstasy, that would be the vibe.
There's a vibe that you get, and I'm not saying everybody should do it, but what I'm saying is there's a vibe that you get when you're communicating on ecstasy.
It makes it almost impossible to have arguments with people.
It's weird.
You communicate with people in this open way that you would never even attempt if you weren't both on MDMA. Yeah, we actually have a study starting in the next month or so where we're going to give two people MDMA at the same time to a couple.
But one of them has PTSD, and one of them, it affects the relationship, but doesn't have PTSD. Oh.
And so this was...
A major, major breakthrough because the first study with psychedelics was in the modern era was 1990 with Rick Strassman with a DMT study.
And ever since then, now for the past 26 years, it's only been one person getting MDMA or psilocybin or LSD or anything at a time.
So this is the first time that we've been able to work with two people at a time and give them MDMA. And it's also the study that's in informal collaboration with the Veterans Administration National Center for PTSD. It's a therapist that used to work within the National Center who's now at Ryerson University in Toronto who developed this approach.
And who was introduced to us through the work of Richard Rockefeller, who was opening the doors for us with the National Center for PTSD. And we met this woman, Candace Monson, who's the researcher.
And she's developed what's called cognitive behavioral conjoint therapy.
And conjoint means couples.
And so it's a cognitive behavioral sort of scripted how you kind of think about your trauma and exercises about it, but it's for couples.
And so when they were thinking how to blend MDMA with traditional non-drug psychotherapies that are used by the VA, The couples therapy they thought would be the most logical because it helps you to have those kind of communications.
You're the better listeners.
You're more empathic.
You can get over stuck arguments.
And the PTSD really does affect the relationship in a lot of ways.
And the researchers have all these measures of the relationship, of the style of communication between the people.
We really care about the CAPS, the Clinician-Administered PTSD Scale.
But it's going to be tremendously exciting, and we've been able to get permission for the first time to give two people MDMA, and we'll be able to monitor that.
But couples therapy, even though it's a tremendous use of MDMA, will never make it through the FDA because you can only take diseases.
You have to treat a disease.
It's not for personal psychotherapy.
It could be anxiety disorder or PTSD or depression.
If there's something wrong and you have a substance that makes that wrong better, why does something wrong have to be something you look at in a petri dish?
It's obvious there's a condition and a solution to that condition.
I mean, just the fact that you're not dying from feeling like shit about your marriage, it doesn't mean it's not a problem, you know?
I mean, that's so stupid.
Yeah, it will be one of the best uses of MDMA. I mean, that's like making toothpaste illegal.
It's like, you know, unless you have like a serious dental disorder and you really need to clean the holes, you know, like you have like some sort of a horrible root canal that's about to happen.
It's the idea that you can somehow or another keep people from doing what they want to do.
And I think that this idea of, again, psychedelics because, hashtag psychedelics because, of coming out of the closet, of people sort of saying that this has been helpful, and that this is something good, and we should be able to do this.
And I think the eventual use, we're sort of backing into this use in couples, but it's really about making MDMA into a mess for PTSD better.
And it's also about trying to understand what's the drug and what's the context.
So while we had this context I was describing of this non-directive therapy of the unconscious being the guide, other people, like cognitive behavioral, they give you all these exercises.
To think about and how you think about your trauma and where and when your triggers are and all different kind of thought exercises.
And so we're seeing that MDMA is like a general tool.
And so because it's a non-profit drug development, we're trying to work with as many other therapists as many other combinations of treatments that they want to use to explore if they want to blend MDMA with it.
And so we have this 960 grams of some of the world's purest MDMA. Don't tell me where it is.
It's just infuriating that it's taken this long for people to recognize what other people have said.
What other people have said for a long time.
And I understand the idea of having rigorous scientific testing, but at a certain point in time, there should be enough anecdotal evidence and lack of...
I mean, how many people have died from MDMA? Has anybody?
So MDMA affects your temperature controls, which is one reason we measure temperature, although in therapy, but in a clinical setting lying down, there's no problem with temperature.
But there is some weirdness to this idea that we need a substance like it's classified.
Whether, you know, no matter...
Whether it's legal or illegal, it gets classified.
And when you make something a drug, and that drug can only be used when there's an ailment, then you lock out the whole possibility of performance-enhancing substances.
We don't disclude across the board performing-enhancing substances.
That's essentially what coffee is.
And it's mandatory.
I mean, coffee breaks are written into union bills.
I mean, when they make a contract, they write in coffee breaks.
We've always had coffee breaks, right?
That's a break-to-ticket drug, a productivity drug.
It's the most inherently therapeutic of all the psychedelics.
So when you ask me why did I choose MDMA, I think one part is it is the most inherently therapeutic.
People tend not to have bad trips.
The kind of bad trips people have is when they take MDMA in a recreational setting and difficult emotions come up and they're with friends that just want to party and they try to stuff the emotions down.
Well, there's certain people that really shouldn't be allowed to chew gum, and we should take them into account, too.
There's certain people that are going to stub their toe every time they walk, and I don't think we should nerf the world.
And I think it's super important to recognize when you're looking at all these numbers and statistics that there is a certain percentage of these people in this world that are helpless.
Sometimes they would, there's test kits, the dance-safe cells, and sometimes to fool the test kits, which turn a certain color, if there's MDMA in it, there's been pills that are one part MDMA, nine parts caffeine.
Wow.
Because there is the stimulant aspect and people stay up.
One of the things that my wife said about me when some of the neighborhood teenagers, when we had our teenagers, were thinking of...
Coming to visit me at Boom Festival in Europe, which is one of these festivals where they have the most harm reduction.
And these were teenage boys.
And what my wife said about me was that I wasn't really good at prevention, but I was good at rescue.
And so that's, for me, prohibition versus public health.
You know, prevention, you know, prohibition.
But if we can be good at acknowledging the risks but being prepared for them, the same way that festivals have medical tents and people have all sorts of physical problems.
Yeah, but the problem is there's not a strict prohibition on dangerous things.
So the precedent's already been set of freedom.
That precedent of freedom we would like to extend across the board.
That's what we want.
You can't tell me that I can go to a bar and drink my fucking lungs out and smoke cigarettes all day long and I can take pain pills and I can do all these things, but I can't have a joint.
That they knew they couldn't make it illegal to be black or illegal to be a hippie, but they could look at the drugs that those groups were using and selectively criminalize and prosecute them and use them to break up those communities.
And that they knew they were exaggerating the science and that the drug war was a political war against certain kind of drug users who were considered to be a problem to Nixon and Ehrlichman.
It was something that Ehrlichman said 20 years ago, didn't get that much attention, and he's been dead, I think, 10 years now, but it just came out again in an article, and people are looking at what Ehrlichman said, and it seems intuitively true.
Yeah, but it also triggered into a fear of the unconscious, a fear of the drugs, not just these political parts, but just the drugs themselves and the reasons why they were political.
The FDA made their reputation in the early 60s on blocking thalidomide to be prescribed in America for morning sickness for pregnant women because it caused all these thalidomide babies.
And it was a skeptical woman who ended up winning the President's Medal of Honor, the only person from the FDA, for blocking this drug thalidomide.
Years ago, and he's retired now, but well after I was into doing psychedelics and had dropped out, this is what I was focusing on, he shared with me that he and his medical friends did meth because they were under these ridiculous residencies and they had to work for these really long hours.
So MDMA is kind of like mescaline in a sense that it has that, which is from peyote, which has this psychedelic ego dissolving and things emerging and nonverbal processing and emotional intensity, that it has that from mescaline, but it's not that ego dissolving.
It's more You're calmer and that has the energy from methamphetamine but not in a jittery way because you can sit still, you can meditate.
Meditators are now, you know, some of them have learned from MDMA or psilocybin to deepen a meditative practice.
So you can use these in any number of different ways.
And so you kind of have this paradoxical culmination of methamphetamine and mescaline that produced, you know, the molecule that does something different but reminiscent.
And it It is something that I believe that will be used in initially highly controlled therapeutic settings for particular clinical indications and over time, and by over time I mean 10 or 20 years, there would be a development of psychedelic clinics like hospice centers Hospice centers spread all over America in 30 years.
The first one was 1974. 2004, there was 3,500.
So a place to help people who are at the end of life.
So these are psychedelic treatment centers to help people do ego death or to die to their old selves or to see more or that these centers will be Developed all over America, I think, over a process of once the drugs are approved, and probably MDMA and psilocybin will both be approved around the same time.
One of the other, you know, in 2021 is our current predictions, and then we'll start elaborating these clinics, and then people will get more and more comfortable to it, so that medicalization precedes legalization, and that's what we've seen with medical marijuana.
That the culture gets comfortable through this process of now research and use that they can trust, that they see directly, and they see distribution centers that aren't violent, and people see a system and they then...
The latest poll was 60% of Americans in favor of marijuana legalization.
And if you look around at the world, the world is under so much stress and the environment is under stress and the cultures are bumping up against each other that we need to have all the tools available to manage...
The stress, because it's a tremendously crucial time in human history where we have these capabilities through our technology that we never had before to impact planetary systems.
Yes, and there's this confluence of coincidence of timing that Albert Hoffman, who invented LSD, first off created in 1938 and then accidentally ingested it in 1943, felt that the development of nuclear splitting of the atom...
was occurring contemporaneously with this discovery of LSD and in his view there was this kind of outer technology and this inner technology and that Einstein said the splitting of the atom has changed everything except our mode of thinking and hence we drift towards unparalleled catastrophe what shall be required as a substantially new mode of thinking and Albert Hoffman was like well I do wonder about the The technology,
which, you know, many people think that if it comes from nature, it's really good.
Well, actually, because we're trying to see how we're operating in a public benefit manner and fair trade and all this, I asked the company that's now making us our kilogram of...
We went to the FDA, and we said, is there some way we can take this MDMA, which is just as pure as what we're going to get, and turn it into medical grade?
So you have to take it from every initial ingredient, has to be verified at the source, weighed out, documented, and then you make it, and then it's medical grade.
So of this 400,000, about 75,000 is just to validate all the methods that are being used.
Another 54,000 is...
Three-year stability studies to show that the MDMA can last three years, even though we have MDMA from 1985 that we're still using, that we have purity studies on throughout the years.
But it's about this particular batch.
And actually, our 30th anniversary celebration on April 17th in Oakland at the Scottish Rite Center...
Some of them they felt were particularly more talented than others at it, and they ended up with basically the whole groups of Indians, one tribe would take them to the next tribe.
They had the allegiance of all of these Indians, and they learned to live very humbly.
They didn't take stuff for themselves.
They were incredibly good survivors through amazing hardships, and they saw their humanity with the Indians, and they had sort of conquered through love, through these healings, and then they ended up Getting to where the West was, to where Cortes, I mean, where the conquistadors were, they finally saw burned-out villages and people as slaves, and they were taken captured themselves.
And Alvarez Cabez de Vaca went and was taken as prisoner back, and he had to write this report to The king about what happened to the expedition.
And the black man, Estebanico, he stayed and he traveled up and explored a lot of California and ended up being killed by the natives.
But the story, Henry Miller wrote a tremendous introduction to this story about the salvation of this westward expansion, the opportunity, what it showed is that through this respect, through whatever circumstances they got, they Through cooperation and nonviolence, they had the support.
Yeah, there's the actual original document that Cabeza de Vaca, Elvar Nunez Cabeza de Vaca, The Marvelous Adventures of Cabeza de Vaca, I think is the translation of it.
A lot of people have sort of looked at this story and taken a lot of hope from it that...
Even though it took a lot of death for these people to get to this attitude, and the Indians were, you know, keeping slaves and killing each other, you know, but they were able to have a different kind of...
they got off the boat as those, you know, rampaging people, but they transformed into humanists and humble.
And actually, Cabeza de Baca was able to go on a second expedition To South America.
He was able to talk his way into it, and he did it.
He explored more areas than other people did without killing any Indians, and he discovered the Iguazu Falls, where the movie The Mission was made.
Big waterfalls.
And so he sort of demonstrated that he was a good ambassador between cultures, and tried to still, you know, explore, exploit, but do it in a way of a little bit more collaboration.
It's really interesting to think of cultures colliding like that.
Like some crazy people from Spain getting in a boat, getting washed out of their course, and landing in Florida, climbing out, trying to figure out what the hell's going on, getting attacked, attacking people, being at war, and then four dudes make it through that.
And live.
Can you imagine how cool those guys must have been?
Well, we did a study in Canada with First Nations people who were suffering from addiction because their culture has been under such attack.
But it was Peruvian, Third World Peruvian shamans bringing ayahuasca to work with First Nations people who were addicted with Dr. Gabor Monte, a Western psychiatrist.
Accession run by, and then we were able to support the team that did some outcome measures and suggested that this Third World, First World, First Nations people, that these, it's cultural bumping into each other all over now, more ever than before in the history of the world probably.
Well, first off, they have authority in tribal lands, but a lot of people work in the military or do stuff with the federal government.
So they have the religious freedom to practice the Native American church.
The U.S. Supreme Court upheld, and as Congress, that they can...
But the federal government actually tried to limit it so that if you...
You had to have 25% Indian blood to be part of the Native American church in order to participate in the peyote rituals.
The states don't have that kind of racial requirement, but to try to prevent the spread of this religion from the Native Americans to wider groups of hippies and others that like peyote, you know, they tried to make a racial...
The federal government does have this racial limit, but it's largely ignored, and it's ignored by the states.
It didn't go to the Supreme Court, but the Uniao de Vegetal.
I just came from Santa Fe this morning, and that's where the lead church, the Uniao de Vegetal, was located in Santa Fe, and it was Jeffrey Bronfman.
From the Canadian Jewish Bronfman family from Seagram's fortune, from smuggling alcohol during Prohibition and then building this massive business as one of the grandkids, he ended up becoming appreciative of ayahuasca.
And so he hired the best lawyers and worked on this case.
That they won a unanimous Supreme Court case affirming the union of the plants.
It's two different plants, roots and, you know, vines and leaves.
And you put it together.
So it's the union union de vegetal.
And they have legal protection in the United States.
On the other hand, it's, you know, it's a church.
I went to it, and I was hearing, I went to it twice, and the second time I was like, here's the myth of our church, the origin myth.
And part of it was that King Solomon went to the Amazon and told them how to put these Plants together.
Ayahuasca is having an incredible effect in America.
It's really amazing, the number of different people that are using it, not necessarily in these exact religious contexts, but in kind of shamanistic or personal growth or more, or kind of little modified, or even in these services.
Part of it is how cultural integration – so cultural appropriation but cultural integration.
So they're bringing a tradition from a different culture.
Right.
And they're trying to integrate it at a rate where it doesn't, it grows, it's constitutionally protected, but it doesn't grow too fast.
Maybe there's a way where it could grow too fast, and there wouldn't be the care and the use of the tea, and they want to make sure that it's responsibly handled.
There's a lot of weird stuff in religion, and as soon as you start saying that one person can't do their weird stuff, they go, okay, what kind of weird stuff do you got exemptions for?
And you look at their exemptions, you're like, what?
You can cut baby dicks.
What are you doing?
You're rubbing dirt on your forehead on Wednesday?
What the fuck are you doing?
And the idea that one could make fun of the other is just, at a certain point in time, it's like, you guys have blinders on, okay?
We were talking about this the other day, and tell me if this makes any sense to you.
If you have this idea, when you take...
I've never done ayahuasca, but I've done DMT on multiple occasions, right?
So I've had this psychedelic effect, the most potent version of that, right?
I would wonder if you went in with the intention and had these experiences with the intention to communicate with some benevolent deity that you believe is responsible for all life and all love on the planet.
If you kept...
Thinking of that as you entered into this dimethyltryptamine state of consciousness Isn't it possible that a vast majority of what is happening when you are having a psychedelic trip is The word the word hallucination is very strange because what the hallucination implies is in this world where we're sitting right here with tables and chairs and rooms Something could you could see it,
but it could not be real The problem with that is like What are you seeing, and can other people see it too?
Well, if other people can see it, then it's not a hallucination, right?
So how do you know what other people are seeing?
We really don't, right?
Now, how do you know when you close your eyes and you're on a psychedelic drug, how much of what you're experiencing is your visual cortex interacting with your mind, interacting with these...
Drugs and your creativity and your consciousness, they're colliding and gliding and dancing together along with your imagination.
And in this moment, if you go into it with this intention, your imagination can conjure up This Jesus type character in the ayahuasca ceremony and he can be real and he can be what you want him to be and he could be a manifestation of your own experiences in this life that you've carried around as memories and carried around as emotions and that in this psychedelic state if you continually go to it with that intention it's entirely possible that they do experience something
I think that we see through our own filters, and we see a lot of times what we want to see, and that we can coalesce a lot of feelings and images that are pre-verbal into certain kinds of symbols.
Yeah, so the idea that we ever know the ultimate truth, that it's not somehow or other filtered through our preconceptions.
John Lilly wrote this great book.
One of the things he did I thought was great was called Simulations of God.
And it's like different conceptions that people have of God and how you get to these And then there's a way to transcend that and see something even deeper and deeper, and that we have these filters.
And so the culture and the context is more important than the drug.
So I think one of the issues of the 60s was people had so much faith.
They wanted so much cultural change.
They were so...
It was such a strife-filled time that they had this hope, this unreasonable hope, that the drugs were enough, that the psychedelics were enough, that they would somehow or other bring this connection to the truth, to this new understanding just by themselves.
It's really more about the context.
But the context, and with a proper open context, and in our case, a therapeutic context in the experimental sense, then when you add the pharmacology, It produces really unusual opportunities to go very deep.
And that's what I think we can show, that we can do that and contain it in a regulatory therapeutic healing context that can slowly be accepted by our culture.
And that that's really the The value proposition that we're presenting to the FDA. See, the way you described it is why maps is so important.
And so the reason I brought it back in a way to the science is that We're operationalizing its effect on symptoms.
So whether you have this memory that is actually true, so whether it's Jesus or whether you're remembering childhood sexual abuse, whether that actually...
A few things I leaped over there, but whether that...
Occurred in actuality is an important question for the legal system or for other ways, but from a therapeutic, from a healing, from a compassionate point of view, if this expression, if it's symbolic or actual, if it has the consequence of helping people come to terms with themselves and to get more acceptance about what happened That's what we're looking at.
We're looking at the outcomes.
So I think that that's the practical part.
That's the science part.
It's like there are questions.
A lot of times in my early LSD trips, I wanted God to show up, and I wanted the truth.
So in my bed the next day after my bar mitzvah, I was like, I was the same.
I'm like, I'm not a man.
I'm not any different than I was.
And it took me a couple days where I thought God was maybe busy.
Maybe a lot of people got bar mitzvahed that day.
And after like a week, I recognized, you know, I'm not going to change, and it's going to take something else.
The ritual didn't quite do it.
And then even with my LSD trips, wanting to see God, wanting to have this clarity and not quite getting it, and then appreciating that, that that was a delusion in some ways, that keeping the uncertainty is keeping integrity.
But there's that strong longing for that, for certainty.
Yeah, you're sounding like a dude who's rationalizing that he didn't get to meet God and he's upset.
If God did show up, the whole thing would be different, right?
Maybe God's like aliens.
He just doesn't visit everybody.
But when he does visit, it's a very unique experience and it's real.
I don't know, man.
I think there's a real problem in saying you know what other people experience, whether it's under the influence of psychedelic drugs or whether it's completely sober or Well, it's in a meditative state.
The idea that anybody can tell you what you experienced or what you got out of something is foolish.
So then it becomes a matter of whether or not we're protecting people.
So if our laws are designed to protect people, we should do it scientifically.
We should look across the board at all the damaging things.
And we don't do that at all.
That's why the government never discusses cigarettes.
Because we all know how many people's cigarettes kill every year.
It's in the hundreds of thousands, and no one brings it up.
No one running for president.
No one running for Congress.
They just don't bring it up.
It's not something they want to fight against, because if they do, they'll get slaughtered with money.
So it's not about whether or not they're trying to protect us.
What we should do is make everything legal and then let people figure out what you want to do and not want to do, which is what we do with most things today.
Most things like cigarettes and alcohol that can kill you, we let you try.
Because no one should be able to tell you what to do, man.
If you want to Charles Bukowski it and just drink and smoke yourself to an early grave and just scribble all the cool shit along the way, who gives a fuck?
It's all finite, right?
Who's one person to tell another person that they can't BMX jump or skydive, right?
Well, I think this is another way where MDMA therapy will help.
And I think that there's a lot of people that are haunted by their memories.
Memories of their past, memories of their own failures, memories of things that they did wrong.
And those things can really fuck with you.
People define themselves in this weird way by their past failures.
That's all the experience they have.
That's all they know of themselves.
And people have a very difficult time...
Just saying, okay, well those things are things that I'll never do again.
I made these mistakes and now I am this person who's learned.
And that's a really hard jump for some people because they need some sort of a memory definition of their patterns of behavior.
And when the memory definition, when they look in their own memory and everything is just failures and coming up short and missed your rent and car got repossessed, those kind of failures over and over and over again stack up and you define yourself by those failures.
And it becomes really hard to move forward.
It becomes really hard for people.
And so each little positive step that people can do can be so significant because it alters the course.
There was this Tony Robbins thing once, and I hate to quote Tony Robbins.
He's got some really good quotes.
But one of the things he was talking about was how just incremental changes in your life.
So if you have two cars or two boats that are going in this direction, And one veers off course just five degrees.
Well, if they both go ten miles, this one goes further and further and further from the other one and it keeps going further.
It changes the course.
It changes the direction.
And MDMA therapy or any sort of a psychedelic experience that's boundary dissolving and ego dissolving and it just gets to the raw heart of the matter and allows you this really intense We're good to go.
Yeah, there's this beautiful part of accepting oneself and loving oneself even with all of these failures, even with everything that's happened.
It's not that you deny that it happened or you don't see it.
It's just this sense that you can relax and feel that self-love, and that is what's so rare.
And I think that's why MDMA is one of the most popular illegal drugs in the world, and why It needs and will become a medicine.
And the reason that I selected it is also because training therapists, reaching to the mainstream, so that when we talk about how do we incorporate this as a medicine, it's with healers, it's with doctors and therapists.
And I think what we've found is that we have FDA permission for a study Where we can administer it to therapists in part of our training program.
We're studying the psychological effects of MDMA taken by healthy volunteers in a therapeutic setting.
And it's a double-blind, crossover, placebo-controlled study, but we can bring in therapists from all over the world and give them an MDMA session where they're the patient, and they're seeing our method of how to deliver it.
And so MDMA is something that I think will have a smoother, easier way into psychiatry and into psychotherapy because of it so gentle, because it...
Isn't so much ego dissolving as ego clarifying.
Your defenses are relaxed and you can kind of accept yourself for who you are so you can see more clearly.
And then how you integrate that and how you make it so that that affects your daily life afterwards.
They're not current accepted medical, and there's no currently accepted safety under medical supervision, and no currently accepted medical use, and high potential for abuse.
Schedule 2 drug, and these are the most heavily criminalized drugs.
Schedule 2, except for certain exceptions, in Schedule 2, which are also drugs with a high abuse potential, but have an accepted medical use, like methamphetamine.
So, moving from Schedule 1 for Schedule 2, there's been efforts to try to force the DEA to do this.
But the way the schedules are set up, there has to be...
A currently accepted medical use.
And the data is not there.
And you talked before about, you know, when do you have enough anecdotal data?
I believe that we are so capable of fooling ourselves into believing what we want to believe, into seeing Jesus when Jesus might not be there, that we need science.
We should take marijuana through the drug development system.
I basically started trying to do drug development research with marijuana in 1992. This is the first time, 2016. So there's no established medical benefits of marijuana that have been proven in any scientific way?
Yes, there's been a lot of evidence in Phase 2 pilot studies.
But the definition of real proof is Phase 3 studies, these large-scale studies that you work and negotiate with FDA for the marijuana plant.
Now, GW Pharmaceuticals is a company in England that grows marijuana, takes extracts, Sativex, it's a THC and CBD combination in a pill.
And then they also have Epidiolex, which is CBD for childhood epilepsy.
So they are in Phase III studies.
So there are people working with marijuana extracts in different nonsmoking delivery systems going through the system.
But the plant itself It's highly effective.
It doesn't cause lung cancer if you smoke it.
If you vaporize it, it's even less irritating to lungs.
There's the possibility that a low-cost plant in Israel right now, they grow high-potency trim buds for 50 cents a gram, $14 an ounce.
So I think there's public benefit in making the marijuana plant in smoked or vaporized form into a medicine available It's paid for by insurance as an alternative to all these other medicines.
But there is no effort right now.
We're starting...
Six years ago, we started a study for marijuana for PTSD in veterans.
So we've talked about MDMA, and the idea is to help people with a few MDMA sessions not need MDMA, not need drugs, Sort of reorganize their brain.
But there's a lot of people with PTSD that find marijuana to be helpful.
They don't have the nightmares.
They're more present focused.
And they're thinking, well, maybe I don't want to do this MDMA or maybe it's a supplement.
So there's never been a study of marijuana for PTSD. There's been lots and lots of anecdotal reports, hundreds, thousands of people saying that it's helpful in different ways.
But marijuana is a palliative, meaning that it just treats the symptoms, and it's used usually every day.
So it's taken us six years.
We're about to start the study, and it will take us another several years to finish it.
Part of it will be at Johns Hopkins, part of it will be in Arizona, 76 veterans with chronic treatment resistant PTSD. And we're testing one sample that's high THC, one that's high CBD, one that's kind of THC-CBD combination, and then one placebo.
And we got a $2.1 million grant from the state of Colorado to do this study.
And it's going to be a definitive thing.
And because, again, we're non-profit, we're giving away the protocol.
There's no intellectual property like that.
And so there's a for-profit company, Privateer, that actually has bought the Marley brand, and they have their medical marijuana company, Venture Capital, and they have...
That's hilarious.
Tilray, which is a big marijuana production factory in British Columbia, supplies like 5,000 patients.
They're owned by privateer, and we've given them our marijuana protocol.
And so they're going to use the study with our study, with the same study design, but with their marijuana.
And they're going to vaporize, and we're going to smoke.
And then there's a new study starting in Australia.
There's this guy whose grandchild had...
Pediatric epilepsy and nothing helped and then they tried CBD and it stopped the epileptic seizures to a great extent and then the father donated 33 million to the University of Sydney for cannabis research.
It's the largest grant in the history of the University of Sydney so they're gonna take our protocol and they're going to get marijuana from Tilray but put into capsules as edibles.
So we're gonna have three different studies Similar in design, but smoked, vaporized, and edibles.
We're going to combine the data, and so this is the scientific process.
But it'll take us, it's taken us six years so far just to get the study even started.
The study will be three years.
Then we'll learn from it, and we'd probably need to do another three, four year study of phase three, because this is just phase two.
And in the meantime, we have to break the government monopoly on marijuana, because in the U.S. we're stuck with the government marijuana.
In 1968, Andy Weil actually at Harvard wanted to do a study with marijuana.
And so the federal government started a farm at the University of Mississippi to grow marijuana for research.
Ever since then, the National Institute of Drug Abuse has contracts now, and so the University of Mississippi, Professor El Soli, is now in charge.
They're the only federally licensed, DEA licensed marijuana in America.
And the FDA is a federal agency, so it can only work with drugs that are federally legal.
So the only source of marijuana in America that can be used in clinical research is this marijuana controlled by the National Institute on Drug Abuse, which has been anti-marijuana, with this contract with the University of Mississippi.
And we have tried, MAPS has tried, starting in 2000, to break this monopoly.
And we submitted an application in 2001 with Professor Lyle Craker at UMass Amherst.
We won a DEA administrative law judge lawsuit.
The second time I've sued the DEA and won.
But in the end, they ignore the judges, they ignore the science, and the politics takes over.
And we lost in the appeals court in 2013. So the way I described it, we have this 960 grams of super pure MDMA, but it's not...
So GW Pharmaceuticals started in 1998, combining Sativex with THC and CBD. It was up until just last year that the US government could provide marijuana with CBD in it.
They've not been focused on making these things into medicines.
It's more low-potency, research into the risks of marijuana, and it's the final next step in the medical marijuana story, is to end the obstruction on privately funded drug development research trying to make the plant into a medicine.
And that's what, ironically, It's easier to do research with psychedelics than with marijuana to try to make it into a medicine because we control our drug.
So I'm getting a GMP, MDMA. It's the same stuff we're going to use in phase three that we want to market.
But the federal government marijuana can only be used in research.
It can't be marketed.
And because the strains are all so different, we can't show marijuana helps for PTSD with one strain and then just say, oh, give us approval for any other strain.
Well, I guess this is all important because we want the same sort of stringent It's a hard process to be taking place for a drug, say, for arthritis or something like that.
There's so many drugs that have gone through clinical trials and wound up still, even after all that, being dangerous.
But the problem with this is that we know it's not dangerous.
It's not like there's any question whatsoever about whether or not it's hurting anybody.
The process that we're trying to go through with making the marijuana plant into a medicine is solving the fundamental issue that all of these medical marijuana states that have approved medical marijuana laws, the patients have to buy the medicine themselves.
They don't get it covered by insurance.
That'll only happen when you go through the FDA and you've made it federally legal.
So to go through the FDA process, then insurance companies...
They can be doing studies now and look at the fact that people are using marijuana instead of a lot of more expensive pharmaceutical medications, and that from an insurance company point of view, it could be wise to subsidize marijuana right now.
It just hasn't happened yet, as far as I'm aware, that insurance companies...
In Canada, the Canadian government pays for medical marijuana for veterans.
For PTSD. The Canadian government pays for that, even though there's been no science.
These three studies will be the first on marijuana for PTSD controlled studies.
And so there's the likelihood that once we make it into an FDA-approved medicine, insurance companies will then be willing, now it's federally legal, to cover it as a medicine for what it's been proved to be, particularly if it saves them money on other medicines.
But of course, then the pharmaceutical drug companies are going to, there's going to be a bounce back there.
It's all really the only thing that's holding us back is this nutty system that we have right now that's so complicated to make something as harmless as marijuana become legal.
The system itself, when it's unblocked, isn't really that long.
You just talked about how the Civil War wasn't that long.
With psychedelics, I mean, part of it is also resources.
Do we have the resources to fund the studies?
But in 1992, the FDA had an advisory committee meeting that was about what to do about medical marijuana and what to do about psychedelics and should they be permitted to be studied as medicines.
This was in 1992. So there had been roughly 20 years of suppression of research, crackdown after the 60s.
The FDA had this advisory committee meeting.
The National Institute of Drug Abuse convened a meeting of their animal researchers doing studies on psychedelics and other drugs and animal models trying to figure out what they do.
They recommended human use.
The advisory committee recommended that human research be resumed, and the FDA adopted that.
So that we've actually had this open door with research at the FDA if we had the resources, except for marijuana, because the marijuana was controlled by the National Center of Drug Abuse.
We had broken that.
We'd gotten our own supplies of psychedelics after as their own supplies of psilocybin.
So now the system takes Six to ten years.
Something like that, of doing the research once you have a drug that you think does something to prove it.
And that takes some time, and it costs a lot of money.
But it doesn't cost billions like the pharmaceutical company will tell you.
I mean, we're actually able to make MDMA into medicine, in part because it's a demonized drug, because it's ecstasy.
Governments over the world have spent over 300 million dollars, probably more by now, on research with MDMA. If you go into the scientific literature in Medline and you put in MDMA or ecstasy, there's over 5,000 papers.
A lot of science has been done that we haven't had to pay for about the risks.
But even then, when we sort of take that and then Do the kind of studies that we need to do with psychedelics.
It feels like the system takes time to prove it, but we are so good at tricking ourselves.
And there is something to be said for this process.
And so I think when we talk about how come marijuana isn't a medicine, part of it is that the process has been gummed up for 50 years and is still gummed up by this last step.
I mean, there was another step to get access to this federal marijuana.
You had to have a public health service review that was created in 1999 because before that they only gave the marijuana to government researchers.
You couldn't even do your own funded study with marijuana through the FDA because you couldn't get the marijuana.
It was only for their researchers.
In 1999 they created this policy that would open it up.
In their minds, but there was a special review in addition to FDA, DEA, and IRB that we just were able to succeed in getting them to eliminate.
The Obama administration eliminated it last summer, this Public Health Service review.
It's what blocked our marijuana PTSD study for years and years.
That's gone.
The last thing to get gone is this government monopoly on marijuana.
And we're working.
We're planning to resubmit an application from Professor Craker.
We're working with Covington Burling, a big DC law firm, taking the case pro bono to do a legal analysis.
And then we will try to persuade.
We're working with Senator Gillibrand and Senator Warren and others have been engaging the DEA and ONDCP, HHS, in discussions about this monopoly.
There's growing support in Congress.
And this is the last vestige of sort of politics blocking the science with psychedelics or marijuana.
Then the system will have to work with.
And in the meantime, people can go around and legalize.
And then that gets access.
And so we're not saying wait for the science to...
That's why I think I was so motivated to get involved with MDMA because I learned about MDMA in 1982 when it was an underground psychedelic psychotherapy tool under the code name ADAM that the government had no knowledge of.
No, Dallas is where ADAM, MDMA, turned into ecstasy.
So that's where they started selling it above ground.
There's an incredible movie that's going to come out, The Star Club, about the club in Dallas where it really got well known.
But because it had this dual life, one as this quiet underground therapy drug with about half a million doses having been used by around 1984, and then the other was this public ecstasy use.
I thought, okay, now I know about it ahead of time.
I can see the crackdown coming.
Everybody could see the crackdown coming, but now we can organize.
Now we can talk to people about it.
It's not a crime.
We can gather our forces and have people try it even.
And that's where I became really politically involved in the 80s.
And we've been able to do it in a way where Right now we have two senior retired FDA officials who are acting as our consultants to prepare our documents because they felt that there's a strong need for new treatments for PTSD. I mean, they don't necessarily are saying anything about cultural change or spirituality or drug war.
Just for other people, everybody with PTSD. They have watched over the last 15-20 years what we've done and Actually, there's a woman on our staff, Ilsa Jerome, that has been reviewing all these papers, all these 5,000 papers, and developing what's called, in conjunction with other members of our team, an investigator's brochure, a summary of the literature with a risk-benefit kind of calculation.
How you take all of this information, and then what does it mean in terms of the risk that you present to the patients in the study?
And that you tell the doctors.
And the people at the FDA thought that we were doing it fairly in a time when it was being distorted in all these different ways.
And Ilsa is actually a little bit more conservative than I am, and I knew that it was kind of good to let her take the lead in writing this, and that it got the respect of the FDA. So that's where I'm pretty hopeful.
Now, we've also, though, what about the other, the next step?
What's the next step?
We've been accused of, or people have raised the cautionary tale, which I disagree with, but they've said, some people have said, are you making war more easy to wage now?
It's a very narrow perspective, and it's also not taking into consideration the actual Psycho-active effects of that substance because that substance makes someone loving.
So if you think that giving out pills that make you more loving are more likely going to generate more war or make war more palatable, I think the opposite is probably true.
I think the people who become more loving who can relay the experiences of the horrors of war to other people who become more loving because they also get a hold of this stuff, then I think that's more likely to eliminate war or lessen war or at least mitigate it significantly.
Because I think that war is probably mitigated significantly now in comparison to like the sheer numbers of people.
Like in comparison to, you know, 500 years ago, 600 years ago.
And I think that things like psychedelic drugs in particular, but also the meditative techniques, focusing on being in the moment, focusing on learning how to manage your mind.
And there's a lot of things that people are practicing and attempting to use in their everyday life today.
Mindfulness and it's a subject that's repeated very often and people are trying to find a better way of approaching different dilemmas in their life and this is a tool for those things.
It's a tool for those things that should be considered alongside of yoga.
Alongside of meditation, alongside of reading self-help books, alongside of having good friends you can open up with and you can discuss things together and get encouragement from each other and maybe even criticism from each other.
All those things exist in all sorts of different forms and they exist in psychedelics as well.
A lot of the times, I mean, especially, I find eating marijuana to be one of the most self-analyzing, objective, introspective experiences you can have.
It's like a real wake-up call to any holes you might have in your game.
It just smacks you into place and sends you back out there in the world.
You're like, shit, okay, I got it, I got it, I got it.
Those are tools, and they're all tools that can be used in a variety of different ways, but to deny the fact that they can be used beneficially At this point is really silly because we are finite beings.
We live a short amount of time.
Wouldn't it be nice if you got rid of most of your bullshit by the time you hit 80?
And I think this sense of, isn't it about time, that it is.
And I think there is a mainstream system that's ready to incorporate, that's reaching out on the other side in a way.
And that this...
Possibility of really integrating this does seem to be the case.
And I think with the military, I think their training is to make people to suppress their emotions and to not feel the emotional consequences, to act in the heat of battle without the emotions.
And I think with MDMA, if you help people feel the emotional consequences of their actions, even if you've healed them from trauma and they want to go back to their units, that they are going to be more careful, more sensitive.
They'll be...
There's a German psychiatrist, Torsten Pasi, and he sort of raised this issue for me.
What about the concentration camp guards?
What if they were tormented and they came to you for MDMA therapy?
You know, you're a German therapist and they come to you.
Would you treat the concentration camp people for their trauma?
And I think the question is, Are people who are worked with in this emotional way for their trauma more or less likely to go back into these situations that produced the trauma in the first place?
I mean, you're not exonerating them for the horrible things they've done, but should, if you're gonna keep them alive, shouldn't you try to make them a better person?
Do you have some sort of responsibility to do that?
I would say the argument, if you want to look at our civilization in, like, the most efficient manner, you want to look at it in the most, like, what is the best way to get our civilization together?
We'll have less assholes, less crazy people, less mean people, less, you know, less psychopathic fucking security guards at Auschwitz.
So if you do have one...
You could probably get a lot of data from studying that guy, and he's obviously going to be in jail for the rest of his life.
Right, and I feel that trying to bring that healing approach, those loving feelings, which MDMA can really generate through oxytocin and prolactin, the hormones released that are in nursing and bonding, MDMA releases those hormones.
And he's compared the post-orgasmic state and the hormonal release to MDMA. And I think when we talk about MDMA, a good way to think about it is the post-orgasmic state.
If you're trying to have this experience, this loving experience, and then kind of bring, appropriate some of that into your daily life, learn and integrate it, then the very next day is one of the most important parts because you're still halfway in, halfway out.
You're able to think about it.
That's where a lot of the integration work gets done.
So in our therapy, we make it so that people spend the night in the treatment center, just so that they don't have to move, they don't have to get distracted, and then there's hours of psychotherapy the next day to help them integrate it.
And then when they go home, we call them every day for a week on the phone, just to check in and see how they're doing.
And I am worried about right-wing backlash, but there's a couple things that we've put into place.
First off, the work with the military.
I mean, right-wing loves the military.
If we're trying to help the military, there's also people are compassionate about childhood sexual abuse survivors.
And so I think that we have enough of a base of...
Evidence and a long pattern since 1992 of the precedence at the FDA that I think we could survive.
The FDA also recently did something very interesting with the abortion bill, RU46, that they made it easier on women.
They eliminated one required step that the science showed that they didn't need.
And so the FDA is very much trying to be science over politics.
I mean, they will have an FDA commissioner that's appointed by and confirmed by president, but at the same time, the people that are there are really focused on science over politics and compassion.
The other part is that we have international strategy.