Taken from JRE #1964 w/Rick Doblin:
https://open.spotify.com/episode/1EMSI2KxCHhbyEwCBnIfsw?si=b75dc222759f451b

We are now at a place where we recently announced that our second phase 3 study was successful and was confirmatory.

Our first phase 3 study was incredibly successful.

And to give you a sense of how successful, and we published this in Nature Medicine, the FDA looks at statistical significance.

So efficacy is determined by basically statistical significance.

And you have to have .05, which means 1 in 20 chance that it's random, that it's not from what you think it was.

You know, that your intervention, your experiment said, yes, it's statistically significant.

That means It's 1 in 20 or lower chance that it's, your finding is random.

And so, if you have 1 in 20 and then you multiply them another 1 in 20, it's 1 in 400 chance that these 2 independent studies have produced results that are random, and then the FDA will approve it.

Our first study was 1 in 10,000 chance that it was random.

How do you get such great statistical significance?

You get it because you have a big difference between the 2 groups, and you also have not that much variability.

So what it means is the people that got MDMA, pretty much of them got major benefits, and the people that got the therapy without MDMA, so I should say, the people that

It doesn't work for everybody, but we had 88% responders.

We had 67% no longer had a diagnosis of PTSD.

had PTSD on average of 14 years, one-third over 20 years.

just another 21% had what's called clinically significant response.

they still have PTSD, but over time they might get better.

If they could have had a forced session, they might get better.

We had nobody attempt—we had actually nobody in the MDMA therapy group tried to kill themselves, tried to hurt themselves.

We enrolled people that have previously attempted suicide.

We did have 1 woman try to kill herself twice during the study, but she was in the placebo group.

We had another woman, it was so difficult for her to confront her trauma that she checked herself into a hospital to not self-harm.

of the most important journals in the world in science, at the end of every year, they publish a list of what they think are the top 10 scientific breakthroughs of the year.

And they chose our study in nature medicine as 1 of the world's top 10 breakthroughs of the year.

special appreciation for what science was willing to do.

Because you talked about beforehand about holes in the brain.

So 20 years before, science had published this article that they never should have published.

And this was by researchers at Johns Hopkins that had been funded by the National Institute on Drug Abuse.

And what they claimed is that MDMA could hurt dopamine.

And they said, oh my God, MDMA can hurt dopamine and it could cause Parkinson's.

And they had, since 1985, it had all been about MDMA supposedly hurting serotonin and causing holes in the brains from serotonin.

And we had done studies in primates before with these same researchers where none of

the primates died from overdoses, there didn't seem to

But the narrative of the anti-drug people, the nationalists on drug abuse about serotonin neurotexicity was sort of diminishing.

And so what they were saying was, well, you're reducing your cognitive reserves.

And so you don't show problems now, but when you get older, you're gonna show problems.

and not only did they not have evidence, but a lot of older people took MDMA and they were fine.

So if they had had this decline of aging, age-related decline, they were all right.

But it does drop your dopamine levels, right?

In the Short term, yes, yes, yes, yes, yes, yes.

It does, but it doesn't do this kind of damage to the brain in that way.

And there's mitigation techniques like with 5-HTP.

We don't use those, but people do use those.

So what we first proposed, in 1992, is when we got permission for the first study with MDMA.

And people had been using 5-HTP after MDMA.

It boosts your serotonin levels quicker, correct?

But what we do in a therapy context, so the FDA, we said, should we try administering with 5-HTP or something like that?

Let's do everything under observation and see what the problems are.

And if you see problems, then we should figure out how to mitigate the problems.

So the key thing that we do is to say to people that when you take MDMA, it's a two-day experience.

And the second day is for rest and for reflection and have no obligations, no appointments, nothing that you need to do.

And that's where people would take 5-HTP if they wanted to.

But we don't see this dip in mood any more in the MDMA group than in the group that gets therapy without it.

So this, people talk about suicide Tuesdays or this depression after you've used up serotonin.

rest part is part of the therapeutic process, so we have never felt the need to recommend that people do 5-HTP.

I mean, if people wanted to do it, it can be helpful, but we just feel that the rest is just as helpful and it's more therapeutic.

So what- But they're not mutually exclusive.

No, we could do both, yeah, for sure, for sure.

So, but what science had, yeah, so this idea of serotonergic neurotoxicity and holes in your brain and time

bomb theories just wasn't working anymore.

It wasn't persuading people, it wasn't persuading the FDA.

and George Riccardi, and it was in primates.

bunch of the primates died of overdoses, and they published a paper in Science that said that MDMA could cause Parkinson's that could hurt dopamine.

the — Science is published by the American Association for the Advancement of Science.

And he fanned the fears of MDMA, and he did that in Congress, and it was great because then he got more money for NIDA.

So he published a press release about this article and it said that taking MDMA was like playing Russian roulette with your brain.

We knew that we'd given MDMA to primates for research and nobody died of overdoses, none of them did.

So we wrote a letter to the editor and we questioned it.

They didn't give it the way people take it, which is orally as well.

And so we ended up forcing them in their minds to try to replicate their results.

They would just have heart attacks or something like that.

Also you get more neurotoxicity in crowds for some reason when animals or people are together than when they're alone, and when the temperature is higher, there's more neurotoxicity.

So they tried giving more MDMA to primates with higher temperatures, more crowded in the cages, and they couldn't replicate the results.

And finally, a year later, they said that, and this was super embarrassing, they had to retract the study, because they were puzzled why they couldn't replicate the results.

And so they took some of the tissue from 1 of the animals that had overdosed and died, And they discovered that they had mistakenly given methamphetamine instead of MDMA.

And that the bottles, they said, that were labeled, MDMA actually had methamphetamine

And so, they got these bottles from a group called Research Triangle Institute in North Carolina.

They provide all the Schedule I drugs for all the NIDA-funded researchers.

So the Hopkins people blamed the people at Research Triangle Institute and said they switched the labels on the bottles.

The people from Research Triangle Institute said they never do that.

They think that it got switched something or other at the site at Johns Hopkins.

The National Institute of Drug Abuse didn't want to find out what was going on, or if they did want to find out, they never made it public.

But they had to retract this data and retract their papers.

And it was the high watermark of neurotoxicity fears.

And at the same time, Peter Jennings was doing a documentary called Ecstasy Rising.

And this was the first documentary that really had a bunch of people talking about the benefits.

And he also talked about this problem with the methamphetamine.

The other thing about methamphetamine versus MDMA is that, you know, for people that know about Adderall and other things, 10, 15 milligrams is a hefty dose, but MDMA, it's 125 milligrams, is a full dose.

And so they were giving the wrong drug in MDMA quantities, And that's why they knocked off a bunch of these primates.

And that's why they claimed that they saw this dopaminergic problems.

And so, ever since then, and that's been 20 years

Do you think, Do you have speculation that was sabotage?

I don't think it was from research triangle.

Do you think it's accidental sabotage or do you think it-

that the researchers wouldn't have done that intentionally, but maybe somebody in

But I do think that the researchers were fundamentally irresponsible to put the paper out because they should have known that there was prior primate studies where dopamine hadn't been damaged.

1980s, early 1990s, we were trying to talk about, yeah, MDMA, serotonergic neurotoxicity.

And so I went to George Riccardi, the same researcher that did the primate study with the methamphetamine instead.

Can you study this in monkeys, in primates?

And again, there was no evidence of overdoses or dopamine.

Also, this was before brain scans came in.

most sophisticated way that was available at the time to look at what's going on in the brain was to do spinal taps and to take spinal fluid and look for metabolites of neurotransmitters in the brain.

recommend, try to get other people to volunteer for it unless I did it myself.

And it was really hard, but the imagery that I did, and again, this is kind of this idea about storytelling.

was telling myself, as this big needle was going into my spine to try to draw out

a woman could give birth to a child, I could at least give birth to my spinal fluid.

It was like way less painful, much shorter, but I could do it.

And so the imagery was I'm giving my birth to my spinal fluid to these researchers so that we can understand what's really going on with MDMA and hopefully make it into a medicine.

and there was spinal headaches that you get afterwards so a couple days afterwards I had headaches but I felt like I could enroll other people, I can encourage other people to do it.

So I was going to New College in Sarasota, Florida, which by the way, DeSantis is now trying to kill and has fired the president.

It's just what he's doing to public education.

of the most, what he called the most woke school in a bunch of transgender people, a bunch of open-minded people.

It started as a private school in the 60s, merged with the state when they ran out of money.

So he fired the president, he stacked the board of trustees, and he wants to turn it into a conservative school.

He's doing it for political purposes to try to show that he's anti-woke and that he is wanting to...

What's going on in public education in Florida is really frightening.

George Soros is actually interested in trying to help out at New College because George Soros actually, even though he's the boogeyman for a lot of the right wing, he funded the Central European University in Hungary after communism.

And it was killed also by Orban in Hungary.

So you go after public education as a way to try to control intellectual narratives.

But anyway, I was at New College's school and we were experimenting with MDMA, and so I got about 35 people or so to get spinal taps,

not just from New College, but from all over, and the spinal taps showed that there

It was, there was a little bit less serotonin metabolites, but also lower serotonin has been linked to risk-taking behavior.

And so, taking drugs is risk-taking behavior, particularly when they're heavily criminalized.

So, it was not evidence that it was serotonin neurotoxicity from MDMA, but it cleared dopamine.

So these researchers should never have ignored their prior data.

They were just so willing to demonize MDMA to get more grant money.


Speaker 0: The Joe Rogan Experience.

Speaker 1: We are now at a place where we recently announced that our second phase 3 study was successful and was confirmatory. Our first phase 3 study was incredibly successful. And to give you a sense of how successful, and we published this in Nature Medicine, the FDA looks at statistical significance. So there's efficacy and safety. So efficacy is determined by basically statistical significance.

And you have to have .05, which means 1 in 20 chance that it's random, that it's not from what you think it was. You know, that your intervention, your experiment said, yes, it's statistically significant. That means It's 1 in 20 or lower chance that it's, your finding is random. And you have to have 2 of those. And so, if you have 1 in 20 and then you multiply them another 1 in 20, it's 1 in 400 chance that these 2 independent studies have produced results that are random, and then the FDA will approve it.

Our first study was 1 in 10,000 chance that it was random.

Speaker 0: It was just incredible. Now, how do you do that? How do you get such great statistical significance? You get it because you have a big difference between the 2 groups, and you also have not that much variability. So what it means is the people that got MDMA, pretty much of them got major benefits, and the people that got the therapy without MDMA, so I should say, the people that

Speaker 1: got therapy with MDMA did great. Not very much variability. It doesn't work for everybody, but we had 88% responders. We had 67% no longer had a diagnosis of PTSD. These are severe PTSD patients that

Speaker 0: had PTSD on average of 14 years, one-third over 20 years. And then we had

Speaker 1: just another 21% had what's called clinically significant response. And

Speaker 0: they still have PTSD, but over time they might get better. If they could have had a forced session, they might get better. And we had a great safety record.

Speaker 1: We had nobody attempt—we had actually nobody in the MDMA therapy group tried to kill themselves, tried to hurt themselves. We enrolled people that have previously attempted suicide. We did have 1 woman try to kill herself twice during the study, but she was in the placebo group. She got therapy without MDMA. We had another woman, it was so difficult for her to confront her trauma that she checked herself into a hospital to not self-harm.

She also was in the placebo group. So the results were phenomenal. And science, the journal Science, 1

Speaker 0: of the most important journals in the world in science, at the end of every year, they publish a list of what they think are the top 10 scientific breakthroughs of the year. And they chose our study in nature medicine as 1 of the world's top 10 breakthroughs of the year. It was phenomenal. And we had

Speaker 1: special appreciation for what science was willing to do. Because you talked about beforehand about holes in the brain. So 20 years before, science had published this article that they never should have published. And this was by researchers at Johns Hopkins that had been funded by the National Institute on Drug Abuse. And what they claimed is that MDMA could hurt dopamine.

This was a study in primates. And they said, oh my God, MDMA can hurt dopamine and it could cause Parkinson's. And that this could be real danger. Now, this was around 2002, 2003. And they had, since 1985, it had all been about MDMA supposedly hurting serotonin and causing holes in the brains from serotonin.

And we had done studies in primates before with these same researchers where none of

Speaker 0: the primates died from overdoses, there didn't seem to

Speaker 1: be any problems with dopamine. But the narrative of the anti-drug people, the nationalists on drug abuse about serotonin neurotexicity was sort of diminishing. People weren't showing problems. And so what they were saying was, well, you're reducing your cognitive reserves. And so you don't show problems now, but when you get older, you're gonna show problems.

So the time bomb theory.

Speaker 2: Did they have evidence of this?

Speaker 1: No,

Speaker 0: and not only did they not have evidence, but a lot of older people took MDMA and they were fine. So if they had had this decline of aging, age-related decline, they were all right.

Speaker 2: But it does drop your dopamine levels, right? Or serotonin levels.

Speaker 0: In the Short term, yes, yes, yes, yes, yes, yes. It does, but it doesn't do this kind of damage to the brain in that way. They recover within a day or so.

Speaker 2: And there's mitigation techniques like with 5-HTP.

Speaker 0: We don't use those, but people do use those.

Speaker 2: Why don't you use those?

Speaker 0: Because we don't think it's necessary. So what we first proposed, in 1992, is when we got permission for the first study with MDMA.

Speaker 1: And people had been using 5-HTP after MDMA.

Speaker 2: But there is a benefit to using 5-HTP. It boosts your serotonin levels quicker, correct?

Speaker 0: Yes, yes, it can be helpful. But what we do in a therapy context, so the FDA, we said, should we try administering with 5-HTP or something like that? They said, don't do that. Let's do everything under observation and see what the problems are. And if you see problems, then we should figure out how to mitigate the problems.

So the key thing that we do is to say to people that when you take MDMA, it's a two-day experience. It's not a one-day experience. And the second day is for rest and for reflection and have no obligations, no appointments, nothing that you need to do. Just take the second day and rest. And that's where people would take 5-HTP if they wanted to.

But we don't see this dip in mood any more in the MDMA group than in the group that gets therapy without it. So this, people talk about suicide Tuesdays or this depression after you've used up serotonin. But I think The

Speaker 1: rest part is part of the therapeutic process, so we have never felt the need to recommend that people do 5-HTP. I don't think it's a bad idea to do. I mean, if people wanted to do it, it can be helpful, but we just feel that the rest is just as helpful and it's more therapeutic. So what- But they're not mutually exclusive.

Speaker 0: No, we could do both, yeah, for sure, for sure. But we don't in the research. We haven't found the need. So, but what science had, yeah, so this idea of serotonergic neurotoxicity and holes in your brain and time

Speaker 1: bomb theories just wasn't working anymore. It wasn't persuading people, it wasn't persuading the FDA. So NIDA funded this study, Una McCann

Speaker 0: and George Riccardi, and it was in primates. And as it turned out, a

Speaker 1: bunch of the primates died of overdoses, and they published a paper in Science that said that MDMA could cause Parkinson's that could hurt dopamine.

Speaker 0: And the editor of

Speaker 1: the — Science is published by the American Association for the Advancement of Science. The president of that was Alan Leshner. He used to be the head of NIDA. And he fanned the fears of MDMA, and he did that in Congress, and it was great because then he got more money for NIDA. Got him over a billion dollars a year.

So he published a press release about this article and it said that taking MDMA was like playing Russian roulette with your brain.

Speaker 0: So it didn't seem right, this article. We knew that we'd given MDMA to primates for research and nobody died of overdoses, none of them did. So we wrote a letter to the editor and we questioned it. They didn't give it the way people take it, which is orally as well. And so we kept- How did they give it?

Speaker 1: They gave it subcutaneously. So they injected it sub-Q. And so we ended up forcing them in their minds to try to replicate their results.

Speaker 2: Can I pause you for a second? How did these primates die of overdoses?

Speaker 0: They would just have heart attacks or something like that.

Speaker 2: Is that common with humans?

Speaker 1: No, no. So here's how this continues. Also you get more neurotoxicity in crowds for some reason when animals or people are together than when they're alone, and when the temperature is higher, there's more neurotoxicity.

Speaker 0: So they tried giving more MDMA to primates with higher temperatures, more crowded in the cages, and they couldn't replicate the results. But they kept defending it in public. And finally, a year later, they said that, and this was super embarrassing, they had to retract the study, because they were puzzled why they couldn't replicate the results. And so they took some of the tissue from 1 of the animals that had overdosed and died, And they discovered that they had mistakenly given methamphetamine instead of MDMA. And that the bottles, they said, that were labeled, MDMA actually had methamphetamine

Speaker 1: in them. And so, they got these bottles from a group called Research Triangle Institute in North Carolina. They provide all the Schedule I drugs for all the NIDA-funded researchers. So the Hopkins people blamed the people at Research Triangle Institute and said they switched the labels on the bottles. The people from Research Triangle Institute said they never do that.

They always test it. They have quality control. They think that it got switched something or other at the site at Johns Hopkins. The National Institute of Drug Abuse didn't want to find out what was going on, or if they did want to find out, they never made it public. So it's never clear how did this happen.

But they had to retract this data and retract their papers. And it was the high watermark of neurotoxicity fears. And at the same time, Peter Jennings was doing a documentary called Ecstasy Rising. And this was the first documentary that really had a bunch of people talking about the benefits. And he also talked about this problem with the methamphetamine.

The other thing about methamphetamine versus MDMA is that, you know, for people that know about Adderall and other things, 10, 15 milligrams is a hefty dose, but MDMA, it's 125 milligrams, is a full dose. And so they were giving the wrong drug in MDMA quantities, And that's why they knocked off a bunch of these primates. And that's why they claimed that they saw this dopaminergic problems.

Speaker 0: And so, ever since then, and that's been 20 years

Speaker 1: ago now.

Speaker 2: Do you think, Do you have speculation that was sabotage?

Speaker 1: Somebody sabotaged it somewhere. I don't think it was from research triangle.

Speaker 2: Do you think it's accidental sabotage or do you think it-

Speaker 0: I don't. I think

Speaker 1: that the researchers wouldn't have done that intentionally, but maybe somebody in

Speaker 0: the lab did it or something. But I do think that the researchers were fundamentally irresponsible to put the paper out because they should have known that there was prior primate studies where dopamine hadn't been damaged. So the other thing is in the late

Speaker 1: 1980s, early 1990s, we were trying to talk about, yeah, MDMA, serotonergic neurotoxicity. And so I went to George Riccardi, the same researcher that did the primate study with the methamphetamine instead. And I said, I want

Speaker 0: to buy you some monkeys. You've just done studies in rats. Can you study this in monkeys, in primates? And he said he did. And again, there was no evidence of overdoses or dopamine.

Also, this was before brain scans came in. And so the

Speaker 1: most sophisticated way that was available at the time to look at what's going on in the brain was to do spinal taps and to take spinal fluid and look for metabolites of neurotransmitters in the brain.

Speaker 0: And I felt like I could not

Speaker 1: recommend, try to get other people to volunteer for it unless I did it myself.

Speaker 0: So I was the first 1

Speaker 1: to get a spinal tap. Jesus.

Speaker 0: And it was really hard, but the imagery that I did, and again, this is kind of this idea about storytelling. So the story I

Speaker 1: was telling myself, as this big needle was going into my spine to try to draw out

Speaker 0: the spinal fluid, was that if

Speaker 1: a woman could give birth to a child, I could at least give birth to my spinal fluid. It was like way less painful, much shorter, but I could do it. And so the imagery was I'm giving my birth to my spinal fluid to these researchers so that we can understand what's really going on with MDMA and hopefully make it into a medicine. And it didn't hurt terribly

Speaker 0: and there was spinal headaches that you get afterwards so a couple days afterwards I had headaches but I felt like I could enroll other people, I can encourage other people to do it.

Speaker 1: So I was going to New College in Sarasota, Florida, which by the way, DeSantis is now trying to kill and has fired the president. It's the Honors College of the state

Speaker 0: of Florida. And it is a- Why is

Speaker 2: he trying to kill it?

Speaker 0: It's just what he's doing to public education. I mean, this was the symbol

Speaker 1: of the most, what he called the most woke school in a bunch of transgender people, a bunch of open-minded people. It started as a private school in the 60s, merged with the state when they ran out of money. So he fired the president, he stacked the board of trustees, and he wants to turn it into a conservative school. He's doing it for political purposes to try to show that he's anti-woke and that he is wanting to... What's going on in public education in Florida is really frightening.

George Soros is actually interested in trying to help out at New College because George Soros actually, even though he's the boogeyman for a lot of the right wing, he funded the Central European University in Hungary after communism. And it was killed also by Orban in Hungary. So you go after public education as a way to try to control intellectual narratives. But anyway, I was at New College's school and we were experimenting with MDMA, and so I got about 35 people or so to get spinal taps,

Speaker 0: not just from New College, but from all over, and the spinal taps showed that there

Speaker 1: was no problems with dopamine. It was, there was a little bit less serotonin metabolites, but also lower serotonin has been linked to risk-taking behavior. And so, taking drugs is risk-taking behavior, particularly when they're heavily criminalized. So, it was not evidence that it was serotonin neurotoxicity from MDMA, but it cleared dopamine. So these researchers should never have ignored their prior data.

They were just so willing to demonize MDMA to get more grant money.

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Rick Doblin Debunks Myths and Details Breakthroughs in MDMA Research