587 - Good News on the Psychedelic Front

Program Notes

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Guest speaker: Rick Doblin

The 2018 Palenque Norte Lecture Schedule

Date this lecture was recorded: August 31, 2018.

Today’s podcast features the 2018 Palenque Norte Lecture given by Rick Doblin, the president of MAPS. In addition to a detailed description of the interaction between MAPS and the Veterans Administration, Rick also gives a detailed account of the now concluded Phase 2 study along with an explanation of how they believe MDMA works to relieve the symptoms of PTSD. As he says about the efficacy of the process he says, “What we found at twelve months is that people keep getting better. So at twelve months, two-thirds of the people no longer have PTSD. And of the one-third who still have PTSD, most of them have had a clinically significant reduction in symptoms, even though they still have PTSD.”

[NOTE: The following quotations are by Rick Doblin.]

“I think we can look very carefully in our society and see that a lot of the people who are suffering but who might try to block what we’re trying to do, if we really look deep into their suffering, a lot of them are really wanting us to succeed.”

“What we found at twelve months is that people keep getting better. So at twelve months, two-thirds of the people no longer have PTSD. And of the one-third who still have PTSD, most of them have had a clinically significant reduction in symptoms, even though they still have PTSD.”

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Transcript

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Greetings from cyberdelic space.

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This is Lorenzo and I’m your host here in the psychedelic salon.

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And a big thank you goes out to Dennis T.

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They’re supporting me as I write these books and produce these podcasts.

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So they’re

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freely available to any and all.

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Also, I need to add that beginning on November 1st, all of my podcasts from here in the Salon

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1.0 track, which is the one you’re listening to right now, well, they’re going to be released

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first on my Patreon supporters’ private RSS feeds, where everything from the Salon and

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more, actually, will become available before I post it here on this feed. Patreon supporters private RSS feeds, where everything from the salon and more actually

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will become available before I post it here on this feed. I will, however, play the first part

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of each week’s podcast where the announcements are going to be, and I’ll post these new Salon1.0

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programs here on this feed one week at a time, once we get enough supporters on the Patreon account to support my efforts here.

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So if the $1 a month model doesn’t work for you right now, well, never fear,

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because eventually every podcast from the salon will also be available on these original feeds for free.

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Well, that’s enough housekeeping for now, so let’s get on with the show.

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Now, for the past two programs, we’ve been hearing about

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some of the dangers of psychedelic substances becoming too tightly bound to a medical and

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therapeutic model. And I think that there have been some sound arguments suggesting that we

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should closely examine the terrain as we move forward toward a relaxation of the legal restrictions on psychedelics.

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However, me, being a lawyer and all,

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I thought that we should also have some input from Rick Doblin,

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who, without a doubt, has been working on this cause longer than almost anyone still standing.

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So if anyone deserves to be heard on this issue, well, it’s Rick.

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As you know, if you’ve been with us here in the salon for a while,

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my friendship with Rick goes back to, well, even before he started MAPS.

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And while we’ve had our differences from time to time,

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and still have some in some instances,

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well, I nonetheless respect his on-the-ground knowledge of the struggle to legalize psychedelic medicines.

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And I also believe that his head is in the right place.

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So my suggestion is for us to take a look at this situation from yet another point of view.

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We’ve heard from a doctor who is part of the phase three study, but who also has questions

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about what this may lead to. And we’ve heard from an activist who is investigating the connections

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between big money, big government, and psychedelic legalization.

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And now we get to hear from one of the people who is right at the center of it all, Dr. Rick Doblin,

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who will be introduced by one of the wonderful volunteers at the Poincare Norte Lectures this past August at the 2018 Burning Man Festival.

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And as a little side note to our fellow saunters who don’t get the joke when

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you hear it, well, when Rick and the emcee talk about Rick having gone to a little community

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college in Cambridge, Mass., well, the school they’re actually talking about is Harvard University.

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So, as us jokers on the West Coast will tell you, calling it a community college does a disservice

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to community colleges.

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And I’m sure that little joke of my own will probably get me in trouble with somebody,

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but hey, if we can’t laugh at ourselves, what’s the point of being human?

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After all, I think we humans are probably the funniest things around, from what I’ve seen.

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So now I’ll shut up, and let’s go back to the playa.

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I am looking at some very brilliant, handsome, beautiful people.

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You’re brilliant because you are here.

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You are smart enough to know that Rick Doblin is in the house.

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Now, you know Rick as the founder of MAPS.

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How many people here knows a little bit about MAPS?

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How many people here love MAPS?

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How many people adore MAPS? Zendo, Zendo, how many people know about Zendo

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we’ll talk a little bit about that too

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but most of all you today are going to get a ton of good news

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and how many people here need good news

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in fact you’re going to come out with a couple specific facts

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that I want you to spread around,

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because this is such good news that we need to spread it.

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Now, Rick, besides creating maps, before that, he got this doctoral degree from this community college in Cambridge, Massachusetts.

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You know, whatever. you know whatever but most of all

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we know Rick for

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what he has done

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what he has created

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and not only with MDMA

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not only with LSD

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not only with

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mushrooms but more

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and most of all we now have him.

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Thank you, Dana, very much.

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And thank you all for coming here

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to hear and talk with us together.

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So to start on the theme of good news,

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I want to share some of the things that have really surprised me.

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And so on October 8th, which is a Monday coming up, one of the veterans that was in our study,

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one of the therapists and myself are giving a talk at a conference.

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And this is a conference that we didn’t anticipate being accepted to speak at,

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but we applied in order to develop this outreach, this mainstreaming.

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But to our surprise, we were accepted.

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So on October 8th, we’re giving a talk at the annual conference

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of the International Association of Chiefs of Police.

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National Association of Chiefs of Police.

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It’s going to be about MDMA for first responders.

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And so we have done a lot of work with veterans.

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In our study that we did just with veterans,

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for political reasons,

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these are part of our Phase II pilot studies.

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We decided just to name the study Veterans firefighters and police officers so we could kind of communicate that what we’re doing is not just for veterans

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it’s not just for um people that we might be sympathetic to that it’s it’s for first responders

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it’s for firefighters and police officers and we didn’t actually anticipate getting any firefighters or police officers,

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but we actually got 22 veterans, three firefighters, and one police officer.

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So this idea of reaching out to the other is really being quite successful.

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And so we recently were at the American Psychological Association

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annual conference in San Francisco.

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And we had a booth in the exhibit hall.

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And across the walkway from us was the psychologist from the Federal Bureau of Prisons.

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And I was looking at them and looking at them and I was thinking, gosh, as long as we’re right across the hall, I’m going to go talk to them about psychedelics for

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prisoners. And so we had this

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discussion about the Conquer Prison Experiment

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which was done with prisoners. It was

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Timothy Leary’s

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main project, one of his main

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projects at Harvard

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with Ralph Metzner and it was about

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giving psilocybin to prisoners before

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they got released and trying to reduce

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recidivism.

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And so I mentioned this study to these psychologists

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for the Federal Bureau of Prisons,

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and they were very interested.

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But then they said, don’t forget the prison guards,

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that they have trauma as well.

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So when they said that, it was just this, again,

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one more sense of breaking these barriers between us and them,

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between the police authorities that have been oppressing people, that have been scaring me.

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I mean, I’m so used to running from the police.

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To speak at a police conference is going to be very healing for me

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we just

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December 19th we had a meeting

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with the DEA at the

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DEA headquarters and we have

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a senior retired

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DEA official acting as a consultant

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for us and as it turned out

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he was in charge

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of the Arizona New Mexico

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border in Mexico so he had big big responsibilities with the DEA he knows in charge of the Arizona-New Mexico border in Mexico.

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So he had big, big responsibilities with the DEA.

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He knows all sorts of people

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in Washington. But the reason that he got

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involved with us is that his son

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enlisted in the Army.

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And his son has PTSD

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and is using marijuana for

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PTSD. So I think

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we can look very carefully

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around in our society and think that a lot of these

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people that are suffering, that we might think are trying to block what we’re trying to do,

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if we really look deep into their suffering, a lot of them are really wanting us to succeed.

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They want to see about new healing therapies for their family, for themselves, and for others.

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for their family, for themselves, and for others.

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So we have this cultural opening that we haven’t had ever before.

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So in the 1960s and in the 50s,

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when there was all sorts of research with LSD and psilocybin,

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nothing ever reached what’s called Phase 3,

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which is the final stage of research you need to do before you can get permission to market a drug.

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And so we are now, in the next few weeks, final stage of research you need to do before you can get permission to market a drug.

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And so we are now, in the next few weeks, about to begin phase three for MDMA-assisted

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psychotherapy for PTSD.

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We just, in a short few hours, encapsulated 9,200 capsules of pure MDMA.

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I used to spend weeks, actually, capping MDMA back in the olden days.

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And it took a long time.

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And so now we’ve got this pharmaceutical machinery for mass-producing MDMA capsules in the final dosage form.

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So we’ve spent now about a million and a half dollars on getting what’s called medical-grade MDMA,

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which we have manufactured in England, and then we ship it to Pennsylvania,

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and that’s where they put it into capsules.

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So we are really on the verge of starting. And I’ll tell you a bit about

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how we got here. And then I’ll talk about where we’re going to go. And then I’ll talk

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about some of the ethical challenges that we’re dealing with. And then we can open it

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up for discussions. Because I think this theme about ethical challenges and how we’re going

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to try to move forward, that’s one of the crucial issues that we’re trying to deal with now.

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So what I wanted to share, first off, is that I spoke earlier today at Burners Without Borders.

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And after my talk, I was approached by this really big, strong, older guy,

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and he just started crying and started talking about how he was a veteran

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and he was ready to give up.

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And that he had tried all sorts of medications and tried all sorts of therapies.

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And he said that he was at the end of his rope and that he was so worried about taking his life or feeling completely hopeless.

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And he was saying that he had heard about our work with MDMA,

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and he was wondering about what opportunities there might be for him to get involved in the therapy.

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And so that was just really sad for me, but also inspiring,

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to realize that there are so many suffering people who are not adequately treated

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by the currently available treatments and

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medicines and that some of them would find their way here to burning man and then find their way

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to my talk in order to just say um you know what can be done what do you have to offer to help

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and so we we actually do have finally um opportunities to help. Right now, there’s roughly one million

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veterans in America that are on disability payments for PTSD. It means they are not fully

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able to function, and they’re receiving disability payments from the Veterans Administration.

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The last time the VA put out a number of how much they pay for disability,

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it was $20,000 average per year for people on disability for PTSD. And so what that means

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is that if we use the 2004 numbers, there’s roughly $20 billion a year that the Veteran

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There’s roughly $20 billion a year that the Veteran Administration is paying to veterans who are incapacitated to some degree by emotional problems from war.

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And when we think about the cost of war,

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we don’t really think about the human cost as much

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in terms of the suffering from our own military.

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And these are mostly young people,

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and these costs are going to go on for 30, 40, 50 years.

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There’s also roughly 600,000 veterans

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who are also receiving disability payments

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for other mental health-related disorders,

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for anxiety, depression, and other things.

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So when you add that up,

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it’s somewhere in the neighborhood of $32 billion

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that the VA is putting out every single year.

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Now, we have been unable to get a single penny from the Veterans Administration to support research with MDMA.

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They’re worried about the politics of it.

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They’re worried about criticism from members of Congress.

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And yet they understand that they, meaning the leadership of the VA,

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the leadership of the Department of Defense, they understand that there are large numbers

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of people that are not adequately treated by the currently available medications, and

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they want to see what they can do without their incurring political risk or helping

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in a direct way.

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So that’s been extremely frustrating.

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We’ve started since 1990

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to reach out to the VA.

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And we had teams inside

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ready to do work. This was initially for

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Vietnam vets. And it would go

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up to the level of the political

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people who were in charge

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of the, this was the San Francisco

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VA, and they would squash it.

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And every few years, we would go back to a different VA with different teams

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of psychiatrists and therapists and it would always get squashed at the political level.

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Until a few years ago,

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I was approached by Richard Rockefeller. And he was

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the son of David Rockefeller. He was from the Rockefeller family.

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And he realized that he couldn’t just sort of coast on the wealth of his family.

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That wouldn’t be good psychologically for him.

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And that he had to find something that was his own.

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And so he became a doctor.

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And then he became the chairman of the Board of Advisors of Doctors Without Borders.

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And from that, he worked in Europe with Kosovo and Serbia.

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And he found hundreds of thousands, millions of refugees.

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And these were all people that had been driven out of their homes,

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that were traumatized, and he was worried,

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what is there that’s available to help all these people?

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There’s not enough psychiatrists, there’s not enough therapists.

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How can all of these people be helped?

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And he started thinking about MDMA.

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And so then he approached us, and we talked about,

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he wondered what was the most difficult thing that we were doing.

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What was our biggest challenge?

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And I said it was our relationship to the Veterans Administration.

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Conveniently, his cousin was Senator Jay Rockefeller

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on the Senate Veterans Affairs Committee.

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So the two of them started working with us to help us engage the VA

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and the Department of Defense in a dialogue about MDMA.

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And what ended up was a multi-year process of negotiations

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that ended up with the decision.

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We had a meeting with the Assistant Secretary of Defense for Health Affairs,

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with the decision, we had a meeting with the Assistant Secretary of Defense for Health Affairs, his team, the Secretary of the VA, the National Center for PTSD, a part of the

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VA, with people from all these groups, and the decision was made that they did not want

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us to start with active duty soldiers.

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What we were saying is that the sooner you can work with somebody after the trauma,

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the better, rather than having it solidifying to chronic severe treatment-resistant PTSD.

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But they were saying that working with active duty soldiers was worrisome in the sense that

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they’re trying to create this idea in soldiers that they should only do the drugs that the

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military gives them. And a lot of these people are young, from a drug culture, more open-minded,

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and they were worried that if they were to permit research with MDMA,

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with active duty soldiers, that so many soldiers would,

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suffering from PTSD themselves, would work to self-medicate.

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So they said, better just start with the veterans.

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And so we arranged to work with one of the leading therapists at the Veterans Administration

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who had developed what’s called cognitive behavioral conjoined therapy.

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And so conjoined means couples or diets.

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So it’s basically cognitive behavioral therapy, but it’s with a couple,

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where one of them has PTSD and it affects the relationship.

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And so the other person is impacted, and then they bring both of the people into the treatment

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process. And what they were interested in doing was seeing how MDMA might blend with

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this essentially couples therapy approach for PTSD. And so they said that the researchers

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though had to work with us using their academic

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affiliation, not their VA affiliation, that we had to pay for the studies. So here we are giving

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tiny maps, giving grants to the Department of Defense and the VA, in a sense, and that the

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patients had to come from outside the VA. And that way they weren’t directly involved.

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They couldn’t be criticized by members of Congress,

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but they were permitting their therapist to work with us.

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And they’d heard so much about love drug, hug drug.

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They thought this couples therapy approach

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would be a good one to start.

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And so we were able to work with Candice and Ann Wagner,

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her assistant, and we’ve completed now six couples,

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and this was called a treatment development study.

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And it’s been phenomenal, this idea.

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We got permission from the FDA, the DEA,

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from the institutional review boards

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to give both members of the couple MDMA

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instead of just the person with PTSD.

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So this is the first time since Rick Strassman in 1990 got permission

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to work with DMT. It’s the first time that more than one person has been dosed at one time.

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And of course now we’re trying to move eventually towards trying to do group therapy

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as a way to see how we can take advantage of groups and also how we can reduce the cost of the therapy.

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But this treatment development study worked so well

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that these VA-affiliated therapists are really convinced

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that MDMA has tremendous potential.

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And it can blend with other therapies.

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We have our own method, which we now call inter-directed therapy.

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And so the concept of our treatment approach originated with Stan Grof and others in the 50s and 60s with LSD.

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And the basic idea is that there is this sense that we all know that our body is the self-healing mechanism.

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Because if we get hurt, our body knows how to repair itself.

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We have to clean out the obstructions, we have to deal with infections,

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but our body has this move towards restoring the original order.

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And so there’s this wisdom in ourselves, in our bodies, in ourselves,

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to try to heal injuries.

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And the thought is that there’s something similar in the psyche,

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which we have called the inner healing intelligence.

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And so that if you can take this as a metaphor,

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there’s some sort of process in the psyche

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that is moving towards integrating split-off parts,

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that’s moving towards healing,

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and then there’s all sorts of emotional blocks that are in the way.

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And what we know about psychedelics is that

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they bring things to the surface that have been suppressed

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or that have never been experienced,

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and that they can help people get out of patterns.

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But there’s an order that things come up with,

00:22:25 ►

that come to consciousness, that we don’t really

00:22:27 ►

understand. And a lot of times

00:22:30 ►

things come through the body.

00:22:31 ►

So one of the doctors that we work with,

00:22:33 ►

Dr. Bessel van der Kolk,

00:22:35 ►

who’s one of the experts in PTSD,

00:22:38 ►

he’s written a very successful book called

00:22:39 ►

The Body Keeps the Score.

00:22:42 ►

And it’s about how trauma is stored

00:22:43 ►

in the body. And it’s about how trauma is stored in the body.

00:22:50 ►

And so this inner healing intelligence will bring things up,

00:22:55 ►

sometimes initially in the body, sometimes ideas or feelings,

00:23:00 ►

and we encourage people to trust that process, to let things emerge.

00:23:04 ►

An example I’ll give is that quite a few years ago, right before MDMA became

00:23:08 ►

illegal, and we were working with a bunch of different people, and I was sitting for

00:23:13 ►

a German psychiatrist. And while we were doing this MDMA session, his arm became paralyzed,

00:23:22 ►

and he was unable to move it.

00:23:28 ►

And so we knew that MDMA doesn’t cause nerve damage.

00:23:32 ►

MDMA is not going to cause any kind of paralysis like that,

00:23:34 ►

that there was something psychosomatic going on.

00:23:38 ►

And so he was originally quite scared about what’s going on with his arm,

00:23:42 ►

and was that going to have permanent damage, what was happening.

00:23:47 ►

And so we encouraged him to really think about it as a psychosomatic process.

00:23:49 ►

We weren’t worried about his arm.

00:23:52 ►

And so what happened then over the next couple hours is he started telling this story about how because he was a doctor,

00:23:58 ►

his father at one point was on life support,

00:24:02 ►

and he had a meeting with his mother and the rest of the siblings,

00:24:06 ►

and they decided that their father would not want to be sustained by machines,

00:24:11 ►

and that they would sign an order to take him off all of these life support systems.

00:24:17 ►

And because he was the doctor, he had to sign this order.

00:24:23 ►

And so, as he was explaining

00:24:25 ►

this, his arm was still paralyzed.

00:24:28 ►

And then he says, and the problem

00:24:30 ►

is I hated my father.

00:24:32 ►

And so he

00:24:34 ►

further elaborated that he was conflicted.

00:24:36 ►

Did he actually kill his father?

00:24:38 ►

Was this something that he acted out

00:24:40 ►

of hatred? Or did he act out

00:24:42 ►

of love? Or how was this

00:24:44 ►

actually, how did he interpret it? How did he act out of love or how was this actually um how did he interpret it how

00:24:46 ►

did he understand it and the more that he talked about it then the more he started thinking that

00:24:52 ►

his mother was in favor of it his father’s wife that his siblings were in favor of it his father

00:24:59 ►

was really suffering and that it really was a humanitarian thing to take him off of life support.

00:25:05 ►

And as he sorted it out, that he did really act from a position of love rather than hatred,

00:25:11 ►

the feeling started coming back to his arm.

00:25:14 ►

And by the end of the session, he was fully operational again.

00:25:17 ►

So this idea of this inner healing intelligence,

00:25:21 ►

conflicts come sometimes through the body, sometimes through ideas,

00:25:26 ►

and we don’t know exactly why this order is. And so we talk about our therapeutic approach

00:25:34 ►

is to support people in whatever is emerging, and to do that in a way that helps them to

00:25:42 ►

experience things as fully as possible.

00:25:45 ►

One of the beautiful things that Stan Grof has talked about

00:25:48 ►

is about this emotional process of how you get healing.

00:25:53 ►

Many of you may have been in psychedelic states.

00:25:56 ►

I’ve certainly been in them where it seems like it’s never going to end.

00:26:00 ►

It seems like you’re stuck in these horrible spots,

00:26:02 ►

and it’s never going to end, and how are you going to move forward?

00:26:06 ►

And so what Stan has described for those kind of moments,

00:26:11 ►

he said that the full experience of an emotion

00:26:16 ►

is the funeral pyre of that emotion.

00:26:20 ►

The constant in life in the universe is change.

00:26:23 ►

And if you can fully experience something,

00:26:26 ►

even if it’s grief or sadness or fear or anger or a feeling of trapped,

00:26:32 ►

if you can fully experience something, then it will change.

00:26:36 ►

Then it will grow.

00:26:37 ►

Then something new is coming.

00:26:39 ►

So that’s the essence of the therapeutic approach,

00:26:41 ►

that we have this faith that the order that things

00:26:46 ►

come in is unknown to our conscious mind but it’s something that we should honor

00:26:52 ►

and open up to and that there’s this therapeutic approach this inner directed

00:26:59 ►

therapy which is focusing on the therapist not coming with an agenda, not doing, you know, for example,

00:27:07 ►

guided imagery can be very, very effective in therapy, but we don’t use guided imagery.

00:27:13 ►

We want the inner directed, we want the person to be their own guide.

00:27:18 ►

We don’t even use the word guide because guide for the therapist implies that we know where people need to go.

00:27:24 ►

And we don’t fundamentally believe that we know where people need to go, and we don’t fundamentally believe that we know where people need to go

00:27:27 ►

or where the experience needs to go.

00:27:30 ►

And so we’re working in that kind of a context,

00:27:35 ►

and what we’re doing is trying to demonstrate both to treatment-resistant patients

00:27:42 ►

but also to the whole field of psychiatry and psychology,

00:27:45 ►

and to the FDA, that this general approach has merit.

00:27:50 ►

So I said before that we operate a little bit on faith, but it’s not so much faith.

00:27:56 ►

There’s no proof of this kind of inner healing intelligence, but the faith is based on data.

00:28:02 ►

It’s based on outcomes. And to see that this

00:28:06 ►

approach has produced incredible outcomes. So to give you an example of what we’ve learned in

00:28:11 ►

phase two, we have 107 PTSD patients that we’ve treated in Israel, Switzerland, Canada, and the

00:28:20 ►

United States. And these range from women survivors of childhood sexual abuse

00:28:25 ►

and multiple abuse, so that that would be called complex PTSD.

00:28:30 ►

We work with people who have just had a single attack of rape or assault

00:28:35 ►

or something like that.

00:28:36 ►

We work with people that have had workplace accidents, car accidents,

00:28:39 ►

operations that they’ve got PTSD from medical problems.

00:28:43 ►

And we’ve worked with veterans with

00:28:45 ►

war-related PTSD, with firefighters, police officers, all different kinds of PTSD. And so

00:28:51 ►

what we’ve been able to show in this phase two process is that the therapy that we’re working

00:28:59 ►

with works regardless of the cause of PTSD. So that was one of the most important findings

00:29:05 ►

that we were able to get in Phase 2

00:29:07 ►

because the SSRIs, the only drugs that are available

00:29:10 ►

by prescription for PTSD,

00:29:15 ►

work not that well.

00:29:17 ►

They have a small effect size,

00:29:19 ►

and they work more in women than in men,

00:29:21 ►

and they failed in combat-related PTSD.

00:29:26 ►

So that was a big question for us.

00:29:30 ►

Would our therapy work regardless of the cause of PTSD?

00:29:32 ►

And so it turns out that it does.

00:29:36 ►

We also demonstrated that we could work in a safe way. I mean, many of you may have heard that sometimes people take MDMA at raves and dance and overheat and die.

00:29:43 ►

And so that has happened.

00:29:44 ►

It’s extremely rare, but it does happen.

00:29:47 ►

Sometimes people have heard about that

00:29:49 ►

and have heard about drinking water

00:29:51 ►

and occasionally people have drank

00:29:53 ►

too much water and died from that,

00:29:55 ►

from hyponatremia.

00:29:58 ►

And so what we’ve been able to demonstrate

00:30:00 ►

is that those kind of risks

00:30:02 ►

are not from MDMA by themselves.

00:30:05 ►

They’re from a combination of MDMA and the environment.

00:30:08 ►

And when we create a different kind of environment in a therapeutic setting,

00:30:12 ►

we don’t see these problems.

00:30:14 ►

We don’t see very much in the way of temperature rise.

00:30:16 ►

We don’t give people water, actually.

00:30:19 ►

We give them electrolytes, fluid, fruit juices, things with electrolytes.

00:30:23 ►

We control their fluid intake.

00:30:25 ►

We do a lot of medical screening beforehand.

00:30:28 ►

The one thing MDMA will do is increase your blood pressure and your heartbeat,

00:30:32 ►

so we do screen for heart problems.

00:30:35 ►

We do work with people with controlled hypertension.

00:30:37 ►

We do the stress test to make sure they can handle a little bit of exercise.

00:30:42 ►

But we’ve been able to demonstrate that in our setting,

00:30:46 ►

we can administer MDMA in a safe manner.

00:30:49 ►

Now, that’s physically safe.

00:30:51 ►

There is some concern that people with PTSD

00:30:54 ►

have a high rate of suicide and suicide attacks.

00:30:58 ►

And so we have had no successful suicides.

00:31:02 ►

We track that very carefully.

00:31:05 ►

I just learned that we did have one person

00:31:09 ►

who attempted suicide

00:31:12 ►

between the second and third MDMA session.

00:31:14 ►

I’ll explain a little bit more our therapy method later,

00:31:17 ►

but the point here is that this woman did this

00:31:21 ►

in a way that she would obviously be rescued.

00:31:25 ►

She wasn’t really trying to kill herself.

00:31:28 ►

But it turned out that the reason was that she had had such a difficult life

00:31:33 ►

and that in this therapeutic environment, it was so healing for her

00:31:38 ►

that she was starting to be worried about ending the therapy

00:31:43 ►

and it being back out on her own. So this was, in a way, a cry for help to continue the therapy and it being back out on our own.

00:31:45 ►

So this was, in a way, a cry for help to continue the therapy,

00:31:50 ►

which we’re not able to do, actually.

00:31:52 ►

We have a very time-limited, standardized therapy for everybody.

00:31:57 ►

Once the drug’s approved as a medicine, then that can be different.

00:32:00 ►

Then people can have more sessions or fewer sessions.

00:32:03 ►

But we have this time-limited intervention.

00:32:06 ►

And so some people have never really been in a loving therapeutic healing environment.

00:32:12 ►

And once you’re in something like that and you feel how nurturing it can be,

00:32:16 ►

it can be very terrifying to think about how that might affect people being off on their own.

00:32:22 ►

So that’s the big concern that we have about

00:32:25 ►

moving to phase three will be, you know, will we have any of these really serious emotional

00:32:32 ►

reactions? We would, according to the FDA, that we would be able to survive that if several,

00:32:37 ►

even if more than one person commits suicide in our study, because there’s such a base

00:32:42 ►

rate of suicide in this group, FDA really

00:32:46 ►

does take a look at risk-benefit.

00:32:48 ►

And so that gives us kind of hope if that happens.

00:32:52 ►

But of course, we’re going to try very hard to make sure that that doesn’t happen.

00:32:56 ►

So we’ve been able to demonstrate safety.

00:33:00 ►

And we’ve been able to demonstrate it works regardless of the cause of PTSD.

00:33:04 ►

and we’ve been able to demonstrate it works regardless of the cause of PTSD,

00:33:09 ►

and we’ve been able to demonstrate something even more impressive, I think, which is that of the people that have been in our study,

00:33:15 ►

all have been treatment-resistant, all have had chronic PTSD,

00:33:19 ►

and on average severe to extreme,

00:33:22 ►

what we showed is that two months after the last MDMA session,

00:33:27 ►

roughly 61% no longer have PTSD.

00:33:32 ►

So it’s really…

00:33:35 ►

So the two-month follow-up after the last experimental session

00:33:43 ►

is what the FDA is going to look at,

00:33:46 ►

and European medicine agents also.

00:33:47 ►

They’re going to compare the outcomes for our control group,

00:33:51 ►

which is going to be therapy with inactive placebo versus therapy with MDMA.

00:33:57 ►

At the two-month follow-up is what’s called the primary outcome measure.

00:34:01 ►

But we also do a 12-month up. And that’s more for insurance

00:34:05 ►

companies. And that’s to look at the durability of the effect and to try to demonstrate that

00:34:11 ►

the effects last, hopefully, for most people. And also we want to look at what’s called

00:34:16 ►

healthcare utilization. We want to try to demonstrate that people who have, we already

00:34:21 ►

know that people who have PTSD go to the emergency room more often with panic attacks.

00:34:25 ►

They have more heart attacks.

00:34:27 ►

They have more physical problems, all sorts of problems that come from the stress of being constantly traumatized.

00:34:34 ►

And so we want to show that there’s a reduction.

00:34:37 ►

Well, we want to show if there’s a reduction in all these other health care aspects.

00:34:42 ►

And so we do a follow-up at 12 months.

00:34:45 ►

And what we found at 12 months is that people keep getting better.

00:34:49 ►

So at 12 months, two-thirds of the people no longer have PTSD.

00:34:54 ►

And of the one-third that still has PTSD,

00:34:57 ►

most of them have had a clinically significant reduction of symptoms,

00:35:01 ►

even though they still have PTSD.

00:35:04 ►

And so what we’re finding is that we start this process,

00:35:09 ►

but then people continue it on their own.

00:35:12 ►

Once you’ve learned that these materials, these emotions

00:35:15 ►

that you thought were too powerful or too sad,

00:35:19 ►

that you might be trapped in them or that you can never get out of them,

00:35:22 ►

once you’ve learned a little bit how to process them,

00:35:29 ►

then that is something that you can continue to keep doing over and over on your own so this this catalyzes a self healing process that continues

00:35:33 ►

beyond our therapy so that’s been really important the other main thing that we

00:35:39 ►

learned data introduced me by saying that I went to this community college in Boston.

00:35:47 ►

One of the past presidents of this college had this great statement. I actually opened

00:35:54 ►

up one of our meetings with the FDA about it. He said that, never forget, there’s always

00:36:00 ►

a Harvard man on the wrong side of every issue.

00:36:11 ►

And so my dissertation was about the regulation of the medical use of psychedelics in marijuana.

00:36:15 ►

And one of the biggest scientific challenges of doing this research is how do you fit within the model that the FDA has,

00:36:19 ►

which is a placebo-controlled double-blind study,

00:36:22 ►

randomized placebo-controlled double-blind study.

00:36:22 ►

a placebo-controlled double-blind study,

00:36:24 ►

randomized placebo-controlled double-blind study.

00:36:29 ►

And that’s the method that is actually applied for every single drug to show that it’s really evaluated

00:36:33 ►

safety and advocacy.

00:36:34 ►

But it’s very difficult, virtually impossible,

00:36:37 ►

to do a double-blind study with psychedelics

00:36:40 ►

that’s effectively double-blind for most people.

00:36:43 ►

So that if you’ve ever taken a psychedelic,

00:36:47 ►

you probably can tell it apart from nothing.

00:36:53 ►

Now, there are a few times when we have an ability

00:36:59 ►

to give MDMA to therapists as part of their training.

00:37:03 ►

And that was a tremendous sign from the FDA that they were willing to really work with

00:37:08 ►

us in a fully reasonable way.

00:37:12 ►

Because as we mainstream from various very committed original therapists, many of whom

00:37:19 ►

have a background in psychedelics, and consciousness and change and meditation as we try to move

00:37:25 ►

into a broader world of therapists most of them have not done MDMA or

00:37:32 ►

psychedelics and we feel that therapists are going to be more effective if

00:37:36 ►

they’ve done the drug themselves it’s not that every therapist who’s done MDMA

00:37:41 ►

is better than every therapist who’s not done MDMA, but it’s just each

00:37:45 ►

therapist would be more effective than themselves if they had never done the drug. So we made a case

00:37:50 ►

to the FDA about that, and they agreed. And so we actually have a study where we can take people

00:37:56 ►

from all over the world to give them MDMA. And we’ve had this happen two times where psychiatrists,

00:38:03 ►

traditional psychiatrists, who work with trauma,

00:38:06 ►

who have watched six days of videotapes of therapy sessions, who’ve talked about our manual,

00:38:13 ►

our treatment method, who’ve done a 12-hour online course, who’ve also come together for another week

00:38:20 ►

in person to learn about working with teams. We always work with a male-female, well, we work with a two-person team,

00:38:26 ►

almost always male-female.

00:38:28 ►

Usually it could be two males or two females,

00:38:30 ►

but the idea is, you know,

00:38:32 ►

at least for our phase three, a male-female

00:38:34 ►

co-therapy team, so that

00:38:36 ►

people have been through that, and then they

00:38:38 ►

now, the next

00:38:40 ►

step is for them to take MDMA

00:38:42 ►

in a therapy setting, and then the final

00:38:44 ►

step is for them to work with one patient open open label, meaning no double blind, supervised by our training team,

00:38:51 ►

so that they have that experience with patients before they start working in phase three.

00:38:54 ►

So we’ve had two times where, and one of these therapists is here camping with us.

00:39:00 ►

He’s the chief psychiatrist for the Dutch Ministry of Defense. And he’s one of

00:39:07 ►

the top experts in PTSD around the world. And so he’s been working a lot with all the

00:39:12 ►

different approaches for therapy. And so on his first, so the way it goes is that we have

00:39:20 ►

a four-day program. You come in, you get, it’s really a five-day. You come in, you get oriented. It’s really a five-day. You come in, you get oriented.

00:39:25 ►

The next day, you get, it’s an eight-hour session.

00:39:29 ►

You’re either going to get MDMA or placebo.

00:39:32 ►

And with the two therapists there for you,

00:39:34 ►

then there’s a day of integration.

00:39:36 ►

Then there’s a day where the crossover.

00:39:38 ►

Whatever you got the first day,

00:39:40 ►

you get the opposite on the second day.

00:39:41 ►

So if you got MDMA the first day, you get the placebo.

00:39:44 ►

If you got the placebo, you get MDMA. So twice it’s happened, once with this psychiatrist,

00:39:49 ►

once with another psychiatrist, that somehow they had this intuition that they were going to get

00:39:54 ►

MDMA the first time. And so while they were waiting for this MDMA to come on, they started

00:39:59 ►

feeling all sorts of physical things. And then they started processing really deep trauma from

00:40:04 ►

their childhood. And they started working through different issues. And then they started processing really deep trauma from their childhood,

00:40:06 ►

and they started working through different issues,

00:40:08 ►

and they had these incredibly productive sessions

00:40:11 ►

that lasted pretty much eight hours.

00:40:15 ►

And at the end of the session, we asked people to say, to guess,

00:40:19 ►

did you get MDMA, did you get the placebo?

00:40:21 ►

We asked the patients.

00:40:23 ►

Often the patients, the

00:40:25 ►

therapists have a co-therapist there, so we train both at the same time. And then we ask

00:40:30 ►

our two male females. So in this particular case, everybody was 100% convinced that this

00:40:36 ►

was MDMA. And then the next day, there was more integration work, and it worked really,

00:40:40 ►

really well. And so then comes the third day, the crossover period,

00:40:45 ►

and everybody’s thinking, this is going to be easy.

00:40:47 ►

This is going to be the placebo.

00:40:49 ►

And the psychiatrist described how after he took this pill,

00:40:54 ►

after about an hour, he said his jaw just dropped.

00:40:58 ►

And he couldn’t talk for four more hours.

00:41:02 ►

And he had one of his big things.

00:41:04 ►

And I came there the day

00:41:05 ►

after, two days after this actually,

00:41:07 ►

and at one point he was looking at the books

00:41:09 ►

that was in the treatment room, and he was

00:41:11 ►

going like, look,

00:41:14 ►

pointing to his heart, like it’s all in here.

00:41:16 ►

That all his book knowledge

00:41:17 ►

is like, you know, secondary

00:41:19 ►

to what’s in your heart, to what you’re feeling.

00:41:22 ►

And so he was

00:41:23 ►

very amazed at how what he had been able to do with his mind

00:41:28 ►

on the first day to convince everybody that it was MDMA,

00:41:32 ►

once he actually had MDMA, everything was easier and deeper and more profound.

00:41:38 ►

So occasionally the placebo does work.

00:41:42 ►

And the only other time it worked like that in our therapy training program was another

00:41:46 ►

psychiatrist who also had never

00:41:48 ►

done MDMA before.

00:41:49 ►

So what I had thought in my

00:41:51 ►

dissertation, and I was super proud

00:41:53 ►

that I had solved the double-blind

00:41:56 ►

problem, and I thought that the best

00:41:58 ►

way to address

00:42:00 ►

it is not with inactive

00:42:01 ►

placebo, not with amphetamines

00:42:04 ►

or another drug,

00:42:06 ►

because therapists would be able to tell it apart. The patients would have learned a lot about MDMA. They would

00:42:10 ►

probably be able to tell it apart. But I thought the solution would be low dose of MDMA versus

00:42:16 ►

full dose of MDMA. And the challenge was going to be finding the dose of MDMA that was high enough

00:42:22 ►

to produce enough experiences that it would be confused

00:42:26 ►

in a significant way with the full dose, but not so high that it really became very therapeutic

00:42:32 ►

so that it would become almost impossible to tell the groups apart.

00:42:36 ►

So that was my solution to the double-blind problem.

00:42:39 ►

And my dissertation committee, including some experts in FDA drug development, all thought

00:42:45 ►

that’s great. I saw that. So then when we started doing the phase two studies, we tested

00:42:49 ►

25 milligrams, 30 milligrams, 40 milligrams, 75 milligrams, 100 milligrams, 125, and 150.

00:42:57 ►

And the way we administer these drugs, it’s always, it’s 10 in the morning till 6 at night,

00:43:03 ►

eight hour sessions. And there’s a half, at night eight hour sessions and there’s a half

00:43:05 ►

at two and a half one and a half to two and a half hours after the initial administration

00:43:10 ►

the therapist and the patient talk about it and we administer a supplemental dose that’s half the

00:43:16 ►

initial dose and so what that does is it extends the plateau so that it’s a very long session

00:43:23 ►

occasionally if you administer that one and a half hours,

00:43:26 ►

it can make it a tiny bit stronger.

00:43:28 ►

If you wait until two and a half hours, two hours,

00:43:30 ►

it just sort of extends this plateau.

00:43:32 ►

So that’s our model.

00:43:34 ►

And so we were trying to figure out which is the dose

00:43:36 ►

that we want to do for the control group

00:43:39 ►

and which is the dose that we want to do for the experimental group.

00:43:44 ►

And so the way I opened up this meeting with the FDA

00:43:47 ►

was about how the Harvard man on the wrong side of this issue was me,

00:43:51 ►

that my whole theory was totally wrong, and it did not work.

00:43:55 ►

Now, this might not apply for psilocybin,

00:43:57 ►

but I’ll say for low-dose MDMA,

00:43:59 ►

what we discovered that 25, 30, and 40 milligrams in PTSD patients

00:44:04 ►

makes them more anxious.

00:44:06 ►

It doesn’t reduce the fear.

00:44:08 ►

It doesn’t really help them process the emotions.

00:44:12 ►

And they’ve been struggling with emotions that they haven’t been able to deal with for a very long time.

00:44:17 ►

And now they’re in a situation where they’re being asked to deal with it,

00:44:21 ►

and they actually don’t like it.

00:44:24 ►

And they do worse than if they had had

00:44:26 ►

no MDMA at all. So we’ve done a series of studies where people get therapy without any MDMA at all

00:44:33 ►

versus therapy with low doses, and so it turns out that the low doses, people still get a little bit

00:44:39 ►

better from all this time and attention and therapy, but not as much as if they had no MDMA at all.

00:44:50 ►

So what that meant for the FDA was that they could choose blinding.

00:44:54 ►

We could produce more effective blinding by using low-dose MDMA,

00:44:58 ►

but it would make it easier for us to show a difference between the two groups than if we used no MDMA at all.

00:45:02 ►

And so we basically left it to the FDA and said there is no solution and you can

00:45:07 ►

choose blinding or you can choose making it harder on us to show a difference between the two groups.

00:45:13 ►

And that’s what we suggest. We suggest that it be, the real issue is if you can do stuff with therapy,

00:45:19 ►

why bother add a drug? So also we want to know what are the side effect profiles of people going through therapy

00:45:26 ►

with PTSD without a drug too. What is the baseline of side effects? So we learn that better if there’s

00:45:33 ►

no drug as well. And so the FDA ended up agreeing that that’s how we would do it. That we would

00:45:38 ►

work with therapy with inactive placebo versus therapy with our full dose MDMA.

00:45:44 ►

therapy with inactive placebo versus therapy with our full-dose MDMA.

00:45:47 ►

And then what we discovered, to our surprise,

00:45:50 ►

I personally like 125 milligrams.

00:45:52 ►

I think that’s really good.

00:45:55 ►

I don’t really like 75 milligrams as a dose.

00:45:57 ►

It’s kind of halfway there, halfway not.

00:45:59 ►

I’d rather do more.

00:46:02 ►

As the saying goes, more is more.

00:46:14 ►

And so with our study with veterans, firefighters, and police officers,

00:46:17 ►

what we decided to do was to do three different doses,

00:46:20 ►

30 milligrams, 75 milligrams, and 125.

00:46:22 ►

And that was going to be a way.

00:46:25 ►

At this point, we thought maybe 75 would be a good control. We weren’t sure. And so what happened in that study, which really surprised us,

00:46:32 ►

was that the 75 milligram dose group actually did better than even the 125. And now they

00:46:40 ►

were, the 125 group, by the way, works randomly. They were higher on depression, much higher on depression than the 75 milligrams group,

00:46:48 ►

so that may be at some point a blunting effect.

00:46:51 ►

So we can’t say for sure 75 is better than 125,

00:46:55 ►

but it helped us to understand about the mechanism of action.

00:47:01 ►

And I’ll explain a bit later how it modified what we’re going to do in phase three.

00:47:06 ►

But the mechanism of action, many of you may have heard that in the work in the 50s and 60s with LSD

00:47:11 ►

and psilocybin and in the modern work with psilocybin for depression, for alcoholism,

00:47:20 ►

for nicotine addiction, for OCD, that there’s a clear correlation. The most reliable finding

00:47:26 ►

is that the depth of the mystical experience

00:47:29 ►

is linked to the therapeutic outcome.

00:47:32 ►

The more somebody goes beyond the ego,

00:47:35 ►

has this unitive sort of sense of connection,

00:47:38 ►

the more that they can draw strength from that.

00:47:40 ►

People with addiction, people feared of death,

00:47:42 ►

people that are isolated,

00:47:44 ►

they don’t have a lot

00:47:46 ►

of that sense of

00:47:47 ►

this sweep of history,

00:47:50 ►

this persistence,

00:47:51 ►

this transcendence of time and space,

00:47:55 ►

this

00:47:55 ►

tapping into this sort of

00:47:57 ►

essence of love. They don’t have access

00:47:59 ►

to a lot of those things. And so, as it turns

00:48:02 ►

out, the depth of the mystical experience

00:48:04 ►

is correlated with therapeutic outcome for all of the classic psychedelics. And what

00:48:09 ►

we know about the classic psychedelics is that the part of the brain that’s called the

00:48:13 ►

default mode network, which is essentially your resting state where we have, it’s equivalent

00:48:21 ►

to the ego in a sense. It’s the closest we understand to the ego structures in the brain.

00:48:27 ►

And that’s where we sort out all of our different needs,

00:48:30 ►

our needs for love, our needs for relationship,

00:48:32 ►

our needs for food, survival, work, community.

00:48:36 ►

We’re always trying to sort through what do we need to do.

00:48:39 ►

And this default mode network is kind of this ego structure

00:48:42 ►

that helps us figure out what to do next.

00:48:44 ►

But it also filters out out enormous amount of perceptions that we’re getting subliminal perceptions other

00:48:50 ►

things that we might be wanting to do but we don’t need to do it as much as something else

00:48:55 ►

so this part of our brain in a sense acts as a reducing valve and it only helps us focus on the core things that our sort of ego structure says we

00:49:06 ►

pay attention to and so what psychedelics do is they actually weaken the default mode network

00:49:14 ►

they weaken the filtering structures of the brain so we get more perceptions a flood of perceptions

00:49:20 ►

and then we can see how things are all connected. We move beyond this centered around our ego and have this sense about body sensations and just evolution.

00:49:33 ►

I mean, this idea of how colors and sounds can have synesthesia, all different things that lead to this mystical experience.

00:49:41 ►

And that that’s what works.

00:49:44 ►

And that’s why a lot of these therapy settings with classic

00:49:47 ►

psychedelics are focused on two things one is bringing up repressed material that people have

00:49:52 ►

not wanted to see not wanted to talk about and then encouraging people to have these mystical

00:49:57 ►

experiences to the extent that that’s possible and so we’ve looked at that we use the same

00:50:03 ►

questionnaires for mystical experience in our mdma experience this at that. We used the same questionnaires for mystical experience

00:50:05 ►

in our MDMA experience research that’s used in the psilocybin and LSD and Ibogaine work.

00:50:12 ►

And so what we’ve discovered is that there is no correlation between therapeutic outcome

00:50:18 ►

and mystical experience with MDMA. And surprisingly, around one-third of the people in our study had a

00:50:26 ►

full mystical experience with MDMA, according to this questionnaire. The sense of love,

00:50:32 ►

the sense of feeling warm and connected, a sense of self-acceptance, deeply felt positive

00:50:37 ►

mood. A lot of the things of the MDMA experience map pretty well onto the mystical experience.

00:50:46 ►

the MDMA experience map pretty well onto the mystical experience. But there is no correlation.

00:50:53 ►

And so what we know is that PTSD changes the brain. And the way it changes the brain, and this is regardless of the cause of PTSD, is that the amygdala, which is the fear processing

00:50:58 ►

part of the brain, becomes hyperactive. That you do studies about brain activity and there’s more activity in the amygdala

00:51:05 ►

in people with PTSD on average

00:51:07 ►

than not. And PTSD also

00:51:10 ►

limits activity

00:51:12 ►

in the frontal cortex where we think

00:51:13 ►

rationally. So our ability

00:51:16 ►

to rationally say that noise is

00:51:18 ►

just a car backfire, it’s not a bomb

00:51:20 ►

or that person who’s

00:51:22 ►

wearing clothes that was similar to the person

00:51:23 ►

that attacked me,

00:51:25 ►

the ability to kind of differentiate that the trauma is not happening again, that gets weaker.

00:51:32 ►

People’s prefrontal cortex is reduced.

00:51:35 ►

They’re more motivated emotionally, and it’s a very difficult situation for people.

00:51:41 ►

And MDMA, in contrast, does the opposite.

00:51:46 ►

So if we were to design a drug to treat PTSD, it would be MDMA. MDMA reduces activity in the amygdala so that the fear

00:51:53 ►

tags related to memories of certain incidents or certain episodes in one’s life, they’re

00:52:01 ►

reduced so that we can look at the incident, the traumatic experience,

00:52:05 ►

in more detail. And people’s memory is enhanced for the trauma. And a lot of times, people

00:52:12 ►

have suppressed them. It’s particularly painful about their trauma that they don’t even remember.

00:52:19 ►

So MDMA enhances memory, and then it increases activity in the frontal cortex. So we think more rationally about things,

00:52:27 ►

and then it increases activity between the hippocampus and the amygdala.

00:52:33 ►

And so what that means is that the hippocampus is where we help put memories into long-term storage.

00:52:39 ►

And so you could say in a sense that PTSD, people’s traumatic memories are never fully processed.

00:52:46 ►

They’re too painful.

00:52:47 ►

They’re never fully processed.

00:52:48 ►

They’re sort of stuck in this loop that never gets them into long-term memory.

00:52:54 ►

And under MDMA, with reduction of fear, with enhanced rationality,

00:52:59 ►

MDMA also stimulates the hormones of oxytocin and prolactin.

00:53:06 ►

So nursing mothers have more oxytocin.

00:53:09 ►

You have more oxytocin and prolactin when you’re in love.

00:53:13 ►

So these are the hormones of nurturing, of bonding, of connection,

00:53:18 ►

and they’re increased.

00:53:20 ►

So people have the ability to establish a more trusting relationship with the therapist.

00:53:25 ►

They can accept their own feelings more.

00:53:28 ►

And so what seems to be happening with MDMA, with the therapeutic use of MDMA,

00:53:33 ►

is a process called fear extinction and memory reconsolidation.

00:53:37 ►

And so what happens is that you’re able to look at this trauma or series of traumas.

00:53:44 ►

Most of us will be traumatized

00:53:47 ►

in our lives through something or other, either directly or indirectly. Just thinking about

00:53:52 ►

refugees, thinking about what’s happening to the environment, thinking about just being

00:53:59 ►

empathic that you get secondary PTSD. But a lot of us will have actual accidents or abuse or something

00:54:09 ►

that happens to us. And so roughly 90% of the people that have traumatic experiences do not

00:54:14 ►

get PTSD. There’s a resilience and we can recover from it. But those people that get PTSD tended to

00:54:22 ►

have a series of traumatic events earlier in their life.

00:54:25 ►

And so you kind of go through them under MDMA therapy.

00:54:28 ►

But what happens is that when you are able to take a memory that’s connected to fear,

00:54:34 ►

and the fear is reduced, and you’re able to process it also into long-term memory,

00:54:40 ►

what happens is that memory, what we’re learning,

00:54:44 ►

it’s not like you take a book off a shelf and you read the book

00:54:46 ►

and then you put the book back on the shelf

00:54:48 ►

it’s more like you have to take the book

00:54:50 ►

off the shelf, you’ve got this memory

00:54:52 ►

but then you have to reprint the book

00:54:54 ►

you have to recreate this memory

00:54:56 ►

and that’s called memory reconsolidation

00:54:59 ►

and so what’s happening

00:55:00 ►

is kind of a switcheroo here

00:55:02 ►

where you’re switching the fear

00:55:04 ►

from that prior memory, where you’re switching the fear from that prior

00:55:06 ►

memory now you’ve processed the fear you put it in the past and the peacefulness that you have

00:55:12 ►

from MDMA and that sense of self-acceptance that’s the memory that gets reconsolidated with that

00:55:19 ►

memory of the episode so that then the next time you remember it, it’s in the past. It’s not in the present.

00:55:26 ►

And it’s something that you can look at with a peaceful sense. And so that helps us to understand

00:55:32 ►

why 75 milligrams, which is this medium dose, it doesn’t really produce a lot of the waves of body

00:55:40 ►

feelings that we like, a lot of the deep sense of just connected into the universe, but it

00:55:46 ►

does give people an ability to look at their trauma and to do this sort of fear extinction

00:55:55 ►

memory reconsolidation. Richard Rockefeller once told me about how he sat for a bunch

00:56:00 ►

of people, and during three different people he said while they were under the influence of MDMA talked about their fear of flying. Richard was a pilot

00:56:09 ►

and sadly that’s actually how he died in a plane crash a little bit more than

00:56:14 ►

four years ago but he said that even when it wasn’t the purpose of the

00:56:18 ►

therapy these three people talking about their fear of flying under the influence

00:56:22 ►

of MDMA at the end of it they they didn’t think that much of it.

00:56:29 ►

But later, all three of them were able to go on planes.

00:56:32 ►

That somehow or other, that had extinguished that fear of flying for them.

00:56:36 ►

So what we believe is that this process of fear extinction, memory consolidation,

00:56:41 ►

it works really well.

00:56:43 ►

And so our treatment model that we’re using is three and a half months.

00:56:49 ►

And it’s 12 90-minute non-drug psychotherapy sessions.

00:56:54 ►

And there’s three MDMA sessions roughly one month apart.

00:56:58 ►

So a lot of people, when they hear about MDMA therapy,

00:57:02 ►

they kind of confuse it with traditional pharmacotherapy.

00:57:06 ►

And they think maybe you get MDMA every day, or maybe you get MDMA for 20 times or something.

00:57:11 ►

So our model is three times only, once a month, well, three to five weeks apart for three

00:57:18 ►

times.

00:57:18 ►

So it’s three 90-minute sessions with both therapists as preparation before the first

00:57:24 ►

MDMA session.

00:57:26 ►

And then after the MDMA session, it’s eight hours from 10 in the morning till six at night.

00:57:31 ►

We have people spend the night in the treatment center. After the two therapists leave, a night

00:57:36 ►

attendant comes who’s not meant to really do therapy there, but just to be there to take

00:57:41 ►

care of them, to bring them dinner. If they feel like the emotions are too strong,

00:57:47 ►

that they can’t go to sleep, they can call the therapist.

00:57:50 ►

So people are never left alone.

00:57:51 ►

They spend the night in the therapy setting,

00:57:54 ►

which gives them a lot of opportunity to really relax, to rest,

00:57:59 ►

to not have to go home and then come back.

00:58:01 ►

And then the next day, they they wake up they’re rested the therapist

00:58:05 ►

come back and they have at least 90 minutes more of integrative psychotherapy then they can’t drive

00:58:11 ►

home somebody else has to come and take them home because we don’t want people to have any

00:58:16 ►

responsibilities on the second day we don’t want them to have to drive and we also say to them that

00:58:22 ►

while some people have learned for them that taking

00:58:26 ►

something like 5-HTP after MDMA

00:58:28 ►

can make the comedown easier

00:58:30 ►

that we don’t do any of that.

00:58:32 ►

We’re just trying to find out what MDMA does

00:58:34 ►

we encourage them to rest

00:58:35 ►

the second day and we find

00:58:38 ►

that that works terrifically.

00:58:39 ►

Then they go home and we call them

00:58:41 ►

every day

00:58:43 ►

for a week just to check in, just to see how they’re doing.

00:58:48 ►

And then they come back for in-person psychotherapy.

00:58:51 ►

There’s several more between the first and the MDMA and the second MDMA session.

00:58:56 ►

And then we repeat that three times.

00:58:58 ►

And then there’s several three integrative sessions after the last MDMA.

00:59:02 ►

And then we evaluate them two months and 12 years later.

00:59:05 ►

So that’s our basic therapeutic approach.

00:59:08 ►

And so what we’ve decided to do is the first session is going to be 80 milligrams.

00:59:14 ►

The reason we changed from 75 milligrams to 125

00:59:18 ►

is that it’s extremely expensive to make the final dosage form

00:59:22 ►

in multiple different amounts. So we sat

00:59:27 ►

around and did some math and we figured out that if we can use 80 milligrams and

00:59:32 ►

120 as our main doses we can do that with just capsules of 60 milligrams and

00:59:37 ►

40 milligrams and we could save several hundred thousand dollars by doing that.

00:59:41 ►

And we figured it’s not that much different between 75 and 80 or between 120 and 125.

00:59:46 ►

So our first session that people are going to get is always going to be 80 milligrams or placebo.

00:59:52 ►

They’re not going to know which but it will know it’s either going to be 80 milligrams or placebo.

00:59:58 ►

And

00:59:59 ►

then

01:00:01 ►

40 milligrams as a supplemental dose which we

01:00:07 ►

are our approaches that we will always be giving that unless there’s some really good reason not to,

01:00:10 ►

which will rarely happen, but maybe that’ll happen.

01:00:12 ►

People might feel they’ve had enough.

01:00:15 ►

And then the second MDMA session,

01:00:17 ►

we’re switching to being 120 with a 60 milligram follow-up.

01:00:22 ►

And so, again, the idea will be that that’s going to be the standard

01:00:25 ►

unless there’s some really good reason that people just thought

01:00:28 ►

that the 80 milligram was fantastic for them,

01:00:32 ►

but we’ll assume that it’ll go up to 120.

01:00:35 ►

And then the third MDMA session is, again, a discussion.

01:00:38 ►

Do they want to stay at the 120 or go back to 80?

01:00:41 ►

So there’s flexibility that we’re building in.

01:00:46 ►

Some people have talked about trying to

01:00:48 ►

do dosing on the basis of milligram

01:00:50 ►

per kilogram, dosing

01:00:51 ►

body weight. But that’s pseudoscience.

01:00:54 ►

That seems like scientific.

01:00:56 ►

Milligrams per kilogram,

01:00:58 ►

it’s super precise.

01:00:59 ►

But our first phase one dose response

01:01:01 ►

safety study that we did that way,

01:01:04 ►

milligrams per kilogram dosing,

01:01:06 ►

the subjective experience varied more widely than we did fixed dose.

01:01:11 ►

And when you think about it, nobody doses LSD based on body weight or psilocybin.

01:01:19 ►

Sometimes that’s being done, but psychiatric medications are not based on body weight.

01:01:25 ►

You know, you get certain SSRIs, they adjust the dose.

01:01:29 ►

So we feel that this fixed dosing is the way to go.

01:01:32 ►

We’ll start, now, we have this three-session model,

01:01:37 ►

and that’s what everybody’s going to get, that three-session model.

01:01:40 ►

What we have found is that people that are high in dissociation,

01:01:45 ►

that’s a really common strategy during trauma,

01:01:48 ►

is to dissociate and to not be there, in a sense, to withdraw,

01:01:52 ►

so that all this painful stuff, you’re not suffering as much.

01:01:56 ►

But that gets to be a trap when you’ve removed yourself from your experience,

01:02:00 ►

and your experience seems really frightening.

01:02:06 ►

experience and your experience seems really frightening and so that that can i in extremes can lead to dissociative identity disorder split personalities just a certain emotional

01:02:13 ►

numbness and so we find though that people on the high on the dissociation scale tend to need

01:02:20 ►

more sessions than people that are not high on that scale. So many people can really do a lot of progress in the first and second session.

01:02:29 ►

We’re very much opposed to a one-session model

01:02:32 ►

because we don’t want people to think about this as a one-dose miracle cure

01:02:37 ►

and now you’re changed.

01:02:38 ►

There are people that have had one dose and have been cured.

01:02:42 ►

I’ll tell you a story about one of those.

01:02:44 ►

There was a veteran that was in our study

01:02:45 ►

who had been debilitated for years by PTSD.

01:02:51 ►

And during the…

01:02:53 ►

Everything else had failed,

01:02:55 ►

all the other medications and psychotherapies had failed,

01:02:57 ►

and sort of out of desperation,

01:02:59 ►

he volunteered for our study.

01:03:01 ►

And then in his first MDMA session,

01:03:03 ►

he realized, he started to realize that there was

01:03:06 ►

something that he was gaining from having PTSD, that there were advantages to being disabled with

01:03:12 ►

PTSD. And the advantage that he realized is that that was an expression of loyalty to the friends

01:03:18 ►

of his that had been killed. And that as long as he was constantly thinking about it, that he was disabled by PTSD, he couldn’t lead his life,

01:03:27 ►

that this was the expression of loyalty to his brothers-at-arms

01:03:31 ►

who had died or had been terribly wounded,

01:03:34 ►

and that that was the good part of it.

01:03:36 ►

And then, under MDMA, he was able to switch

01:03:39 ►

and see himself from the eyes of his friends who had died.

01:03:44 ►

and see himself from the eyes of his friends who had died.

01:03:50 ►

And from that position, he was sort of getting into their minds,

01:03:54 ►

and he was realizing that they were thinking, if they could be alive to think,

01:03:57 ►

that they were thinking their lives had been lost,

01:04:03 ►

and they would not want him to throw away his life with PTSD as an expression of loyalty.

01:04:07 ►

That in fact, they would want him to live even more.

01:04:11 ►

They would want him to live for them because they couldn’t do it.

01:04:13 ►

They would want him to live as much as he could,

01:04:16 ►

to be as happy as he could, to be as fulfilled as he could,

01:04:18 ►

not to be debilitated from PTSD.

01:04:22 ►

And so then he said, okay, he realized that and said, okay, what am I going to do for the rest of my life?

01:04:30 ►

And in that moment he was healed from PTSD and then he said yeah it’s it’s astonishing

01:04:35 ►

then he said to himself I’m on opiates for pain and I’m in somewhat addicted to

01:04:43 ►

opiates for pain but I’m not really really taking these opiates

01:04:47 ►

for pain I’m taking them for escape and he said I don’t need these opiates anymore I’m not going to

01:04:52 ►

do them ever again and then he said I don’t need drugs at all I am cured I don’t need MDMA I’m not

01:05:00 ►

even going to go to my second MDMA session I I’m done. And we said, it’s super great you’re done,

01:05:06 ►

but would you be willing to at least

01:05:08 ►

you can drop out of the treatment,

01:05:10 ►

but at least do the outcome

01:05:11 ►

measures so we can see how you’re doing.

01:05:14 ►

And he agreed to do that.

01:05:15 ►

And so at the two-month follow-up, he did

01:05:17 ►

not have PTSD.

01:05:19 ►

After just one session.

01:05:21 ►

And so then it’s getting near the 12-month

01:05:23 ►

follow-up, and he’s doing fine, but he’s starting to think, maybe I could learn some more from MDMA. after just one session. And so then it’s getting near the 12 month follow up.

01:05:25 ►

And he’s doing fine, but he’s starting to think,

01:05:26 ►

maybe I could learn some more from him today.

01:05:30 ►

You know, that was a good experience.

01:05:31 ►

Maybe I could learn some more.

01:05:33 ►

And we said, this is kind of difficult for us

01:05:35 ►

because you’re outside the window of the protocol.

01:05:37 ►

You know, we have a strict protocol.

01:05:39 ►

It’s only for people with PTSD.

01:05:41 ►

So we said, we’ll sort this out a little bit,

01:05:44 ►

but at the 12 month months go ahead and take the

01:05:46 ►

measure it’s called the caps the clinician administered PTSD scale and see if you still

01:05:52 ►

have PTSD and as it turned out he took the measure he still did not have PTSD 12 months later and that

01:06:00 ►

was about seven years ago and now he’s volunteering in Cambodia to help other people less fortunate than him.

01:06:07 ►

So it’s just a tremendous story of how one MDMA session can have these profound effects.

01:06:15 ►

But we don’t really want to encourage this idea of one-dose miracle cure.

01:06:20 ►

And we also think that a lot of times people go deeper on the second session than on the first.

01:06:27 ►

So the first, they’re building what’s called a therapeutic alliance.

01:06:30 ►

They’re getting to trust themselves.

01:06:32 ►

They’re getting to trust the patient, the therapist.

01:06:34 ►

They’re learning about the MDMA.

01:06:36 ►

They’re learning that these therapists are there to help them.

01:06:38 ►

And they’re building this alliance.

01:06:40 ►

And they get also like a tour of their traumatic histories.

01:06:46 ►

alliance and they get also like a tour of their traumatic histories and so the second session is when they can go really deep even deeper than the first session often and we don’t want that now we

01:06:53 ►

it’s a multi-million dollar decision on our part whether to go to a third session in our model or

01:07:00 ►

not and what we’re what our sort of operating philosophy is that our goal is to maximize

01:07:07 ►

therapeutic outcome. We’ll figure out how to make it more economical-ness later, but now it’s like,

01:07:13 ►

what’s the best we can do to help the most people? And we’ve also realized that in the second session,

01:07:19 ►

when people are going really, really deep, A lot of times you might touch on something that feels so complex or so profound,

01:07:28 ►

you might feel, I cannot really resolve all of this

01:07:30 ►

in the second session.

01:07:33 ►

I might not want to open it up

01:07:34 ►

because I know this is my last chance.

01:07:37 ►

And so we find that the second session

01:07:39 ►

goes even better when there’s a third session.

01:07:43 ►

That gives people a clean up.

01:07:45 ►

Now, in our Israeli study, we only did two sessions,

01:07:48 ►

and people did really, really well.

01:07:51 ►

So from an economical perspective,

01:07:55 ►

we probably could have done it with just two sessions,

01:07:58 ►

but we really find that people that are high on the dissociation scale,

01:08:02 ►

a lot of them need the third session.

01:08:04 ►

Some small fraction of them will need a fourth session, but we probably wouldn’t do it right away.

01:08:08 ►

We would let them just sit with the three sessions for six months or a year and then come back again.

01:08:13 ►

But that’s how we’ve arrived at our model.

01:08:15 ►

And so what we’ve been able to do is over the last couple of months, we’ve been able to raise $27 million for Face Free.

01:08:33 ►

All from donations.

01:08:34 ►

It really started about six years ago when Ashana Haley, who was a burner, he loved being here.

01:08:43 ►

I say he, but he’s like a he plus, meaning transgender.

01:08:48 ►

But he never quite felt female, so he was kind of like a he plus.

01:08:53 ►

He actually felt that he got too female at some point,

01:08:57 ►

and then took hormones to sort of bring him back.

01:09:01 ►

And then he realized he didn’t want to be in any one particular place.

01:09:03 ►

He wanted to be going back and forth to see

01:09:06 ►

the world from different places.

01:09:07 ►

He was a brilliant person.

01:09:10 ►

The sad thing is he died at age

01:09:11 ►

01:09:12 ►

in his sleep, and he left us

01:09:15 ►

five and a half million dollars.

01:09:18 ►

And this was when we

01:09:20 ►

decided that we would not spend it.

01:09:22 ►

We would save it for phase three.

01:09:24 ►

The only thing that we did spend of that

01:09:26 ►

was around $400,000 that

01:09:27 ►

he was very interested in

01:09:29 ►

autism, and so we did a

01:09:32 ►

study with autistic adults with social

01:09:34 ►

anxiety, where we’re trying to

01:09:36 ►

work on the social anxiety, not the autism,

01:09:38 ►

and we used a bit of his money for that.

01:09:40 ►

And that study was done by Charlie Grove

01:09:42 ►

and Alicia Danforth. They’ve been here and

01:09:43 ►

camped at this camp, and have talked about it in the past.

01:09:46 ►

And they got really, really good results from that.

01:09:50 ►

But we were able to sort of show that there’s multiple different applications for MDMA.

01:09:58 ►

But that was our first chunk of money we decided to save for phase three.

01:10:02 ►

And then perhaps many of you have been over to the foam

01:10:05 ►

showers at the

01:10:08 ►

Foam Against the Machine camp.

01:10:10 ►

And so that’s run by the Dr.

01:10:12 ►

Bronner Soap Company. And the

01:10:14 ►

senior Dr. Bronner was driven crazy

01:10:16 ►

by the Holocaust and came

01:10:18 ►

out of it with this philosophy

01:10:19 ►

that we’re all one. So that’s

01:10:22 ►

actually brilliant and that’s right. This idea

01:10:24 ►

that this sort of mystical sense, how we’re all one. So that’s actually brilliant, and that’s right, this idea that this sort of mystical sense,

01:10:26 ►

how we’re all connected.

01:10:28 ►

But where he was driven crazy

01:10:30 ►

is he was obsessed with that

01:10:33 ►

and abandoned his children a bit.

01:10:35 ►

He actually had a follower who crucified himself

01:10:37 ►

to sort of get this message across.

01:10:40 ►

And so there’s multiigenerational trauma.

01:10:46 ►

People who are traumatized can pass that on through epigenetics to their children.

01:10:51 ►

And so Dr. Bronner, the original, sort of passed some of that on to his kids,

01:10:56 ►

and he alienated them because he went on this mission.

01:10:59 ►

They were even in foster care sometimes, but then his grandkids have come along and are now

01:11:05 ►

sort of

01:11:07 ►

have the idealistic

01:11:09 ►

mission and the practicality

01:11:11 ►

and so they’ve now built

01:11:14 ►

up the Dr. Bronner’s from

01:11:15 ►

about $2 mi ll i o na ye a r t o$ 125 million

01:11:18 ►

a year in sales, and they give

01:11:20 ►

away 40% of their profits

01:11:21 ►

and so they’ve donated $1 million

01:11:24 ►

a year for five years to MAPS.

01:11:33 ►

And actually Richard Rockefeller helped with, he came with me to meet with David’s brother

01:11:38 ►

and mother to explain to them that David wasn’t nuts to be supporting psychedelics so much and that ended up increasing

01:11:45 ►

their donations and then we’ve received two and a half million a pledge of two and a half million

01:11:52 ►

from one of the early Facebook pioneers we’ve got a million dollars from one of the early Twitter

01:11:57 ►

people we’ve received multiple millions from FedEx inheritance. And then what really happened is in October, I had a meeting with the deputy director of

01:12:10 ►

the National Institute of Mental Health with senior people from the VA and the Department

01:12:15 ►

of Defense and also the Wellcome Trust.

01:12:18 ►

And the Wellcome Trust is the largest charity in Europe, in England.

01:12:21 ►

It’s got about $30 billion.

01:12:23 ►

And so it became clear in

01:12:25 ►

all of those meetings that they all

01:12:28 ►

were interested in what we were doing, but

01:12:30 ►

none of them had done phase three.

01:12:32 ►

NIMH, Wellcome Trust,

01:12:34 ►

they all wanted mechanism

01:12:36 ►

of action studies. How does this actually

01:12:38 ►

work? But the FDA doesn’t care

01:12:40 ►

about that. FDA cares about safety and

01:12:42 ►

efficacy, and so they wouldn’t fund

01:12:44 ►

our phase three. So I was, and the Department of Defense and the VA, it was still too hot politically, so I

01:12:49 ►

was very disappointed for a day or so, and I was thinking, this is really a bummer because

01:12:54 ►

we need all this more money, and it’s not coming from the sources that have all these

01:12:59 ►

incentives to pay for it. And then I started realizing that this is fine, this is good,

01:13:04 ►

because now I’ll be able to say

01:13:05 ►

that we’re going to be able to raise the money

01:13:08 ►

it might take longer but it’ll be a

01:13:10 ►

gift from the psychedelic community

01:13:11 ►

from the burner community to the world

01:13:13 ►

and we don’t have to say the government

01:13:16 ►

helped in any way

01:13:17 ►

You’re listening to the Psychedelic Salon

01:13:24 ►

where people are changing their lives one thought at a time.

01:13:29 ►

When Rick was talking just now about the mechanisms involved with PTSD

01:13:34 ►

and why it isn’t possible to simply let go of a painful memory,

01:13:39 ►

well, I suspect that I probably wasn’t the only one

01:13:42 ►

who recalled the recent testimony in the U.S. Senate

01:13:44 ►

when a woman professor very painfully recalled an incident that took place over 30 years earlier.

01:13:51 ►

And everyone who watched her testimony, even those who opposed her, admitted that the incident still

01:13:57 ►

had a very painful hold on her mind. And in my opinion, she most definitely would be a candidate for this new MDMA treatment.

01:14:06 ►

Now, I know that a lot of former members of the military are fellow salonners here,

01:14:11 ►

and as you know, I’m a veteran myself, and I have some friends who,

01:14:15 ►

well, they still haven’t quite made a smooth transition back after returning from combat.

01:14:20 ►

And I also know that some of their family members are also suffering from PTSD-like symptoms.

01:14:26 ►

Well, my suggestion is, if you know somebody who fits that description,

01:14:31 ►

well then you may want to give them a copy of this podcast to listen to

01:14:35 ►

and give them a link to the MAPS page about their Phase 3 MDMA study.

01:14:40 ►

It, well, it may not turn out to be a help, but at least you can give it a try.

01:14:44 ►

I know how frustrating it can be to have a friend or family member who is living in a dark place

01:14:50 ►

and you feel helpless to give them any aid.

01:14:54 ►

Well, even though telling them about the MAP study may not help,

01:14:57 ►

it will nonetheless help you to overcome that helpless feeling that we have

01:15:01 ►

when somebody close to us is slipping away.

01:15:05 ►

Well, next week I’ll play the second half of this talk for us here in the salon,

01:15:09 ►

and until then, this is Lorenzo signing off from Cyberdelic Space. Be well, my friends. Thank you.

⚗️ alembic

Explorer

587 - Good News on the Psychedelic Front – Pt. 1

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