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086 - MDMA for Post-Traumatic Stress Disorder

Apr 04, 2007, 42 min read

Program Notes

Guest speaker: Michael Mithoefer

MitheoferBurningMan2006.jpg

(Minutes : Seconds into program)

06:19 Michael tells a little about how his study came about and its current status.

08:27 Michael describes the screening, preparation, and flow of the experience for qualified participants.

11:56 “We were able to go back, retroactively, and offer MDMA to everybody that had gotten [only] the placebo so far.”

14:06 “Everybody who’s gotten MDMA has had a significant improvement, either temporarily or sustained. More than half, the majority of people have had a very dramatic and sustained improvement.”

18:35 “This is a pilot study, and we’re not really looking to prove efficacy. We’re looking to prove we can work safely with these subjects, and it has at least has a strong trend toward being effective.”

22:48 A discussion about the neurotoxicity of MDMA.

23:12 “There is still a question about neurotixicity (or at least decreases in some neuro functions) with heavy recreational use. It looks like there probably is some effect, although that is still controversial… . It looks like [using MDMA] less than 50 times there is no effect. It is still not known if there is an effect higher than that.”

28:31 “The question is about how sustainable is the effect. It really looks like, for some people, two sessions is enough to really, significantly heal PTSD.”

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Transcript

00:00:00 ►

Greetings from cyberdelic space.

00:00:20 ►

This is Lorenzo, and I’m your host here in the Psychedelic Salon.

00:00:24 ►

Have you ever had the situation where you had most of your stuff in storage for a while,

00:00:29 ►

and then when you got it all back out again, it kind of felt like a holiday season,

00:00:34 ►

and you were being showered with all kinds of cool presents?

00:00:38 ►

Well, something like that’s been going on around here lately.

00:00:42 ►

As I slowly expand into a full office of my own, well, all kinds

00:00:47 ►

of things that had been buried in storage are now floating back to the surface. And

00:00:52 ►

among them are some of my tapes from the lectures at Burning Man. So today I’m going to play

00:00:57 ►

what was one of our most highly attended talks of the series. It was given around 3 o’clock

00:01:03 ►

in the afternoon on Thursday by

00:01:05 ►

Dr. Michael Mithoffer, who is conducting research into the therapeutic uses of MDMA,

00:01:12 ►

which has the unfortunate street name of ecstasy. The title of his talk was MDMA-assisted

00:01:19 ►

psychotherapy for post-traumatic stress disorder, current research and future possibilities.

00:01:26 ►

And since Michael’s research is largely funded by MAPS,

00:01:30 ►

it only seemed appropriate to have Rick Doblin, the founder of MAPS,

00:01:35 ►

introduce Michael as we all gathered in Theon Village’s big tent

00:01:40 ►

at the 2006 Burning Man Festival.

00:01:43 ►

And if you’re just joining us here in the Psychedelic Salon for the first time today,

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well, first of all, welcome home.

00:01:51 ►

And secondly, I should warn you that many of the recordings of the lecture series

00:01:55 ►

that I produce at Burning Man each year have a lot of extraneous sounds going on in the background.

00:02:01 ►

Now, if you’ve already been to Burning Man, well, then you understand,

00:02:08 ►

and if you haven’t been there, well, I guess you’re just going to have to figure out a way to get there sometime, because there really isn’t any way to explain why

00:02:14 ►

us burners get such a goofy smile on our faces when we hear a whistle going off in the background

00:02:19 ►

during one of these talks. So now, here we go with a little flavor of the playa at the 2006 Burning Man

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Festival.

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Now, Michael has really persevered through all sorts of struggles to get our study started. It’s just been such a tremendous blessing

00:02:50 ►

to be able to work with Michael and his wife Annie

00:02:52 ►

on MDMA research and to kind of see how it’s going.

00:02:57 ►

And we’re studying it in so many different ways.

00:03:00 ►

I don’t know if you know this, Michael,

00:03:03 ►

so maybe this will be a really nice time to say this,

00:03:06 ►

that there’s been, through the analysis of the tapes,

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of the therapy sessions,

00:03:12 ►

that there’s now a clue has come up

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as to how to tell the MDMA sessions from the placebo sessions,

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a verbal thing that you and Annie do,

00:03:22 ►

that we think you’re not aware.

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Have you heard about this?

00:03:25 ►

Good, good, good. This is great.

00:03:26 ►

There is a verbal clue that you and Annie do

00:03:30 ►

that

00:03:30 ►

helps us tell 100%

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so far between

00:03:35 ►

MDMA and

00:03:37 ►

placebo.

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It also, though, comes from

00:03:41 ►

it’s a signal from the patient actually

00:03:46 ►

in a certain kind of a

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dialogue

00:03:49 ►

you know so there’s

00:03:51 ►

it’s a signal from the

00:03:54 ►

patient in a verbal way

00:03:55 ►

that helps

00:03:57 ►

I couldn’t guess it

00:03:59 ►

I couldn’t guess it

00:04:01 ►

well the signal is

00:04:04 ►

that at some point or other in the session,

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the person with MDMA asks how you and Annie are doing.

00:04:15 ►

And it’s because you’re so frequently asking about how they’re doing

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and so caretaking that they end up caring how you’re doing

00:04:22 ►

and they want to know.

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So,

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Michael, if your time

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is now.

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I should say,

00:04:32 ►

well, I’ll just say one other thing.

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Thank you.

00:04:39 ►

Thank you.

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There was one other thing,

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which is that, you know,

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Michael has recently gotten certified again as an emergency room doctor.

00:04:51 ►

So that Michael wasn’t an emergency room doctor, left to become a psychiatrist,

00:04:56 ►

and then started our study.

00:05:00 ►

And because of the requirements of safety, because we were not in any institution,

00:05:05 ►

we had to have an emergency room doctor and nurse in the next room, full-time, on call, $800 at a time or so.

00:05:14 ►

And we’ve spent like $40,000 on this kind of situation with no call for it.

00:05:22 ►

And so Michael went back and has just now got board certified also as an

00:05:25 ►

emergency room doctor.

00:05:32 ►

So that he will be able to

00:05:34 ►

serve multiple roles.

00:05:35 ►

And then the role that is evolving for him

00:05:37 ►

and Annie is, as

00:05:39 ►

we’re getting the training

00:05:41 ►

team for standardizing

00:05:44 ►

a therapy technique

00:05:45 ►

and then having it evolved with trying to start with some clear standards.

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Mike.

00:05:51 ►

Thanks, Eric.

00:05:53 ►

Yeah, I’m sorry my wife Annie’s not here this time,

00:05:56 ►

but we do this study together as co-therapists,

00:06:00 ►

very much the way George Greer and Rick would describe this morning, if you heard that.

00:06:07 ►

So maybe I’ll just kind of run through a description of the study,

00:06:13 ►

a little bit about what our preliminary results are now, and then we can talk about it.

00:06:18 ►

Rick and I first started talking about this about six years ago.

00:06:21 ►

We started working on the protocol.

00:06:23 ►

We had a lot of great input

00:06:25 ►

from other people you’ve heard from today, George and Rickway and Charlie Grobe and Matt

00:06:32 ►

Baggett. So it’s been a real community effort. But we finally, we had to get FDA, then IRB,

00:06:40 ►

then DEA approvals, and we finally got all those two and a half years ago.

00:06:45 ►

We started the study in March of 2004.

00:06:49 ►

Right now we’ve 14 people.

00:06:52 ►

It’s going to be a 20-person study.

00:06:54 ►

Fourteen people have enrolled, 12 have finished, two are almost finished,

00:06:59 ►

and there are a couple more about to start in the screening process.

00:07:03 ►

So we’re getting fairly close.

00:07:06 ►

We do need some more subjects, and we’ve had people from as far away as Hawaii.

00:07:11 ►

The study happens in South Carolina,

00:07:14 ►

but the MAPS does provide travel and lodging expense

00:07:17 ►

for people that need to come a long distance.

00:07:21 ►

So what the study is, it’s studying MDMA-assisted psychotherapy for treatment-resistant post-traumatic

00:07:28 ►

stress disorder.

00:07:30 ►

So it’s not that we’re just studying MDMA, we’re studying MDMA as a catalyst for therapy.

00:07:37 ►

And all these people have to have had at least six months of therapy and at least one trial

00:07:43 ►

of an SSRI for their PTSD

00:07:46 ►

and still have significant symptoms.

00:07:49 ►

Most of them have had years of both.

00:07:53 ►

And the PTSD so far has all been crime-related,

00:07:58 ►

either rape, childhood sexual abuse, physical assault.

00:08:02 ►

We also now have permission from FDA to include war veterans from Iraq or Afghanistan,

00:08:09 ►

and we’re hoping to recruit some, but we haven’t recruited any yet.

00:08:13 ►

That’s one of the things.

00:08:15 ►

It’s been an interesting course because we’ve been back to the FDA repeatedly

00:08:18 ►

asking to expand the protocol in almost every way we’ve asked.

00:08:23 ►

Based on our data as we went along they said yes.

00:08:27 ►

So what happens is we do a phone screening first. We screened about 100 people by phone to get the

00:08:33 ►

14 participants we’ve had so far and then they have if somebody qualifies in the phone screening, they have psychological testing by a psychologist other than us

00:08:46 ►

to measure their PTSD scores.

00:08:50 ►

And we’re using the same measures that were used in the Zoloft and Paxil studies

00:08:55 ►

because right now Zoloft and Paxil are the only two drugs approved by the FDA for PTSD.

00:09:02 ►

So our primary outcome measure

00:09:05 ►

is the same

00:09:05 ►

scale that

00:09:06 ►

they’ve used.

00:09:07 ►

So it’s

00:09:08 ►

in keeping

00:09:09 ►

with what

00:09:09 ►

Rick’s talking

00:09:10 ►

about.

00:09:10 ►

We’re trying

00:09:10 ►

to communicate

00:09:11 ►

with the

00:09:12 ►

FDA in

00:09:12 ►

their own

00:09:13 ►

language.

00:09:14 ►

And then

00:09:15 ►

we have

00:09:16 ►

two

00:09:18 ►

preparatory

00:09:19 ►

sessions where

00:09:20 ►

Annie and

00:09:20 ►

I meet

00:09:21 ►

with people.

00:09:22 ►

First we

00:09:23 ►

meet them

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for the

00:09:23 ►

informed

00:09:23 ►

consent.

00:09:24 ►

Then we

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meet with them twice to prepare them for our approach to the session.

00:09:28 ►

Then they have, to start with, two all-day MDMAs or placebo sessions a month apart.

00:09:38 ►

60% get MDMA twice, 40% get placebo twice.

00:09:47 ►

And in those sessions we spend the whole day with them

00:09:48 ►

we have music, headphones

00:09:50 ►

we spend some of the time talking to them

00:09:52 ►

some of the time they spend

00:09:54 ►

with the focus inward

00:09:55 ►

they’re lying on a futon

00:09:57 ►

we’re sitting on the other side of them

00:09:59 ►

then at the end of that session

00:10:02 ►

they spend the night in the office

00:10:03 ►

with a psychiatric nurse there.

00:10:06 ►

Annie asks them what they want to eat for dinner ahead of time.

00:10:09 ►

She makes a really great meal for them, so it’s a very nurturing environment.

00:10:14 ►

They spend the night. We come back the next day and meet with them again that morning.

00:10:18 ►

Then we talk to them every day on the phone for a week.

00:10:21 ►

We meet with them every week for follow-up integration sessions for a month.

00:10:26 ►

Then we have another all-day session.

00:10:29 ►

Then at the end of

00:10:30 ►

two months after the second one,

00:10:32 ►

again, after the second one, we meet with them,

00:10:34 ►

talk to them every day, meet with them every week.

00:10:36 ►

A lot of attention to

00:10:38 ►

follow-up and integration, which is

00:10:40 ►

really important, because especially

00:10:42 ►

in these people who have

00:10:43 ►

these severe PTSD symptoms,

00:10:46 ►

a lot comes up in the MDMA session that may really need a chance to process and integrate

00:10:53 ►

afterwards.

00:10:53 ►

They may have anxiety or periods of low mood often do come up afterwards, but we don’t

00:11:02 ►

view that as a problem.

00:11:05 ►

We view it as an opportunity to work further with that.

00:11:09 ►

And as long as we’re in contact with them

00:11:11 ►

and have that follow-up,

00:11:14 ►

they tend to move through that.

00:11:16 ►

It tends to become part of the healing.

00:11:19 ►

So originally, that was the whole protocol.

00:11:24 ►

And the FDA at first said we couldn’t give the placebo people MDMA,

00:11:28 ►

even though we asked for that at the beginning.

00:11:31 ►

But then after we did the first five subjects, the data was very promising.

00:11:35 ►

So we sent that to the FDA and we said, okay, we want to give the placebo people MDMA.

00:11:41 ►

Same pattern, two sessions with all the additional follow up and they said yes

00:11:46 ►

so

00:11:48 ►

that was a big relief

00:11:50 ►

because it was difficult at first

00:11:52 ►

just having people get placebo

00:11:54 ►

and nothing further

00:11:55 ►

but we were able to go back retroactively

00:11:58 ►

and offer MDMA to everybody that got

00:12:00 ►

placebo so far

00:12:02 ►

then after

00:12:03 ►

we were using a single dose of 125 milligrams at that time

00:12:08 ►

because we didn’t ask for more

00:12:10 ►

because we didn’t even know if we’d get permission for this.

00:12:14 ►

Then after the first 10 people finished,

00:12:17 ►

the data was still very promising.

00:12:20 ►

We wrote to the FDA and said,

00:12:21 ►

we’d like to add a booster dose and we’d like to add a third session.

00:12:25 ►

They said, okay.

00:12:27 ►

So that’s what we’re doing now.

00:12:31 ►

People only get two placebo sessions,

00:12:33 ►

but then at the three-month mark, when we do repeat symptom measures,

00:12:39 ►

we do the unblinding.

00:12:41 ►

Then we offer them, if they’ve gotten MDMA twice, we offer them a third MDMA session.

00:12:46 ►

If they’ve gotten placebo, we offer them three MDMA sessions.

00:12:50 ►

And they’re the same format, about a month apart,

00:12:53 ►

all these additional follow-up sessions that go with them.

00:12:57 ►

And then along with this, you know, there’s careful medical screening,

00:13:02 ►

lab tests, EKG,

00:13:05 ►

as well as we’re doing neuropsychological measures in the beginning

00:13:08 ►

and after two MDMA sessions.

00:13:12 ►

But also four days after each session,

00:13:14 ►

they meet with the psychologist and get repeat outcome measures then,

00:13:18 ►

and then they get them again three months out.

00:13:23 ►

And that’s where the protocol ends now.

00:13:26 ►

We’re just writing a proposal

00:13:28 ►

to get permission to do a longer term,

00:13:31 ►

go back and retest people after more than a year.

00:13:35 ►

So you can see it’s a very rigorous

00:13:38 ►

kind of well-controlled protocol,

00:13:43 ►

the kind that the FDA is used to seeing for drug development.

00:13:48 ►

So what we’re finding has been really very encouraging.

00:13:55 ►

Again, all these people have had treatment before and failed treatment.

00:13:59 ►

They had to have had a significant level of symptoms.

00:14:03 ►

had to have had a significant level of symptoms.

00:14:10 ►

Everybody who’s gotten MDMA has had a significant improvement,

00:14:16 ►

either temporary or sustained.

00:14:19 ►

More than half, the majority of the people,

00:14:22 ►

have had a very dramatic and sustained improvement.

00:14:26 ►

Others have had less dramatic and sustained or dramatic and not so well sustained.

00:14:29 ►

But, you know, in this group of people with treatment failure,

00:14:32 ►

it’s very dramatic.

00:14:34 ►

And the other thing is,

00:14:36 ►

now that we can get the placebo people MDMA,

00:14:39 ►

we have them as their own controls.

00:14:41 ►

So we did have one person that had a very strong placebo response

00:14:45 ►

who actually thought she got MDMA.

00:14:49 ►

We didn’t think she did, but she thought so, and she had a good response.

00:14:53 ►

The other people who got placebo had no response.

00:14:56 ►

And they went through that whole three months with us,

00:15:01 ►

doing those sessions, spending those days with us,

00:15:03 ►

having all this other therapy,

00:15:05 ►

still no response.

00:15:06 ►

Then we did it again with MDMA.

00:15:08 ►

They had a really significant response.

00:15:11 ►

So, you know, it’s small numbers so far, but it’s really looking like unless something

00:15:18 ►

changes radically, it’s looking very much like we’ll have no reason not to go on to phase three

00:15:25 ►

trials, the larger trials that Rick is talking about.

00:15:30 ►

Yeah.

00:15:35 ►

It’s double blind.

00:15:37 ►

Of course, the blind doesn’t, yeah, you know, we have a pretty good educated guess about

00:15:43 ►

an hour into the first session.

00:15:44 ►

We’re also monitoring blood pressure and pulse every 15 minutes, temperature every hour.

00:15:49 ►

So the psychologist who’s doing the outcome measures, however, doesn’t get to see any of that.

00:15:55 ►

So his blind is actually much better preserved than ours.

00:15:59 ►

But that’s a limitation of the study.

00:16:04 ►

There were pros and cons, but we elected not to use an active placebo.

00:16:08 ►

So that’s one of the limitations, but I still think it’s significant.

00:16:13 ►

Yeah.

00:16:14 ►

In the example of the high-successful report,

00:16:19 ►

Yeah, good question about what are the report is the main ingredient in their good results.

00:16:28 ►

It’s been pretty interesting I think

00:16:28 ►

there are a few people

00:16:31 ►

who report

00:16:33 ►

that a certain symptom

00:16:35 ►

just left at a certain time

00:16:38 ►

like one person

00:16:39 ►

with derealization

00:16:42 ►

very severe derealization

00:16:43 ►

which is kind of a dissociative symptom.

00:16:47 ►

She can tell us when that went away.

00:16:49 ►

It was during one of the sessions, and it was just gone.

00:16:53 ►

There have been a few things like that.

00:16:55 ►

That’s not the rule.

00:16:58 ►

The rule has really been two things,

00:17:01 ►

that they are able to address their, to revisit their trauma without feeling overwhelmed by fear.

00:17:11 ►

And their fear of the fear, and their fear of their emotions is what is overcome.

00:17:18 ►

They have the experience that actually I can feel these things, I won’t be, I’m not overwhelmed, and it’s actually, I can make

00:17:25 ►

it through it. So I think that’s probably the main thing. The other thing, on the other

00:17:30 ►

side of it is, as you might predict, they connect with positive experiences. Like they’ll

00:17:36 ►

say, you know, people come in the beginning, they say, well, yeah, you know, the rape was

00:17:42 ►

eight years ago, and I have a, you know, my husband’s supportive.

00:17:47 ►

I’ve got a good job.

00:17:48 ►

My family’s great.

00:17:49 ►

Why don’t I, I should feel good.

00:17:51 ►

Why don’t I, why don’t I feel better?

00:17:54 ►

They’ve had the experience where they really connect emotionally with that.

00:17:58 ►

It’s not just an intellectual realization that a lot of good things are happening and I survived.

00:18:02 ►

They get it on a deep level.

00:18:04 ►

And that’s the other main ingredient, I think.

00:18:10 ►

Yeah.

00:18:15 ►

Well, the question is about the limitation of giving MDMA to the control group

00:18:21 ►

so you don’t have long-term control.

00:18:23 ►

That is a limitation.

00:18:24 ►

Yeah.

00:18:24 ►

It would be

00:18:29 ►

yeah that’s

00:18:32 ►

a limitation we talked about that for a long

00:18:34 ►

time you know this is a pilot

00:18:36 ►

study and we’re

00:18:37 ►

not really looking to prove

00:18:40 ►

efficacy we’re

00:18:41 ►

looking to prove that we can work safely with

00:18:44 ►

these subjects and

00:18:46 ►

that it has at least a strong

00:18:48 ►

trend toward being effective.

00:18:50 ►

And so it’s kind of a trade-off.

00:18:54 ►

But we

00:18:55 ►

decided this was going to give

00:18:58 ►

us more information about how to

00:18:59 ►

design future trials doing

00:19:02 ►

it this way. And it does

00:19:04 ►

increase the data somewhat

00:19:05 ►

because we have them as their own controls in the short run.

00:19:09 ►

And we do have, you know, we still got the three-month,

00:19:12 ►

everybody, the blind is maintained for three months.

00:19:15 ►

There’s repeat testing then.

00:19:17 ►

So at that point, we do have a valid control group.

00:19:20 ►

For the longer term, you’re right.

00:19:22 ►

group. For the longer term, you’re right.

00:19:29 ►

Yeah.

00:19:33 ►

Yeah.

00:19:35 ►

The question is more specific about the sessions.

00:19:37 ►

A reference that I used for the FDA was Stan

00:19:39 ►

Gross LSD psychotherapy.

00:19:41 ►

Annie and I both trained with Stan

00:19:43 ►

in whole-otropic breath work

00:19:45 ►

so we’re basically using that model

00:19:48 ►

which is to

00:19:49 ►

in a

00:19:52 ►

non-directive way to try to

00:19:54 ►

follow and support the way

00:19:55 ►

the process comes out for the person

00:19:57 ►

so specifically

00:19:58 ►

we encourage them to start out

00:20:02 ►

we encourage them to start out lying down in the futon with eye shades and headphones.

00:20:08 ►

We have a program of music, and we say,

00:20:11 ►

if you haven’t spoken to us in an hour, we’re going to check in with you then,

00:20:15 ►

but you can speak to us any time you want.

00:20:17 ►

We also have an agreement that if nothing about their trauma comes up

00:20:21 ►

at a certain nonspecified point, that we can bring it up. We’ve never had to do that. It trauma comes up at a certain non-specified point that we can bring it up.

00:20:26 ►

We’ve never had to do that. It always comes up. So what happens is a rhythm develops between

00:20:33 ►

periods of them lying with their eyes closed and focusing inward and periods talking to

00:20:41 ►

us. And, you know, sometimes they determine that themselves other times if we’ve

00:20:46 ►

been talking for a while we may suggest to them you know maybe this would be a good time to go

00:20:51 ►

back inside and just see what the medicine is going to show you about this so it’s that kind

00:20:57 ►

of approach it’s you know we’re actually writing a manual which is kind of anathema but if we’re going to go to phase 3

00:21:06 ►

larger trials with multi-centers

00:21:08 ►

we have to have a manual that describes what we’re doing

00:21:11 ►

and we figured well we should be able to describe what we’re doing

00:21:13 ►

so we’re working on that

00:21:15 ►

it’s basically that kind of approach

00:21:18 ►

very non-directed approach approach. Yeah.

00:21:29 ►

Okay, I’ll take those backwards because the last one’s simpler.

00:21:31 ►

One part of the question was how did we get around

00:21:33 ►

the fact that MDMAs is Schedule 1?

00:21:36 ►

Well, I had to get a special

00:21:37 ►

Schedule 1 license from

00:21:39 ►

DEA

00:21:40 ►

to have the MDMA,

00:21:43 ►

to order and possess the MDMA.

00:21:45 ►

That was what took the longest.

00:21:46 ►

It took two more years after we got FDA approval for the DEA to stop stalling.

00:21:54 ►

The FDA could have said no without any problem.

00:21:58 ►

Once the FDA said yes, the DEA really couldn’t say no.

00:22:03 ►

I would have had to have a drug-related felony

00:22:06 ►

or they would have had to show that it would have been diverted.

00:22:09 ►

And we got a safe bolted to the floor and alarms and all that.

00:22:12 ►

So that’s the way that works.

00:22:14 ►

You can get a Schedule I research license.

00:22:16 ►

It’s a separate DA license for that specific drug for that specific study.

00:22:22 ►

The other question was about concerns about

00:22:25 ►

toxicity of MDMA and

00:22:27 ►

the fact that we didn’t, maybe they hadn’t

00:22:29 ►

tried other things like homeopathy

00:22:32 ►

or other gentler

00:22:34 ►

or less

00:22:35 ►

toxic kind of treatments.

00:22:38 ►

Were there specific, what are the

00:22:39 ►

specific concerns you have about the MDMA

00:22:42 ►

toxicity?

00:22:42 ►

specific concerns you have about the MDMA toxicity.

00:22:54 ►

Yeah, I think, well, it’s an important concern that we addressed at length with FDA.

00:22:57 ►

You know, we reviewed all the world literature on MDMA,

00:23:01 ►

and we update that twice a year now.

00:23:06 ►

So it is something to be taken very seriously.

00:23:08 ►

Our understanding of the data about neurotoxicity

00:23:10 ►

is that there’s

00:23:12 ►

still a question about

00:23:14 ►

neurotoxicity

00:23:16 ►

or at least

00:23:17 ►

decreases in some

00:23:19 ►

neural functions

00:23:21 ►

with heavy

00:23:24 ►

recreational use.

00:23:26 ►

It looks like there probably is some effect,

00:23:29 ►

although that is still controversial.

00:23:31 ►

John, help me study with the people that pure MDMA users

00:23:37 ►

is going to help answer that.

00:23:40 ►

So far in preliminary results, it looks like less than 50 times there’s no effect.

00:23:46 ►

It’s still not known if there’s an effect higher than that.

00:23:50 ►

All those studies are kind of problematic.

00:23:53 ►

What was more reassuring to us is that there have been studies using this dosage range

00:24:00 ►

in a controlled setting with before and after neuropsych testing

00:24:05 ►

and before and after PET scans.

00:24:08 ►

Those are the ones done in Switzerland by Franz Goldenweider.

00:24:11 ►

And none of those have shown any effect.

00:24:13 ►

So, you know, it’s research.

00:24:16 ►

We have a 20-page informed consent telling people that we don’t know for sure

00:24:21 ►

whether this could cause neurotoxicity.

00:24:23 ►

But it looks like there’s a

00:24:26 ►

lot of reason to think that certainly in this dosage range, this number of times, we don’t

00:24:31 ►

have any evidence for neurotoxicity. And our neuropsychiatric studies that we’re doing

00:24:38 ►

are bearing that out so far. Theoretically, there can be problems with liver

00:24:45 ►

that have been reported cases.

00:24:47 ►

We

00:24:47 ►

exclude anyone who has

00:24:51 ►

liver disease, and we measure

00:24:53 ►

liver enzymes at the beginning,

00:24:55 ►

and then we measure them again

00:24:56 ►

in the week following the second session

00:24:59 ►

to make sure

00:25:01 ►

they’re not elevated. We haven’t seen

00:25:03 ►

any problems, so I, you’re right.

00:25:07 ►

It has effects on the body,

00:25:11 ►

and it’s always like a risk-benefit consideration for any drug, I think.

00:25:20 ►

But we feel pretty comfortable that this is a favorable risk-benefit ratio.

00:25:27 ►

But, you know, I wish there were more studies on things like homeopathy or PTSD.

00:25:33 ►

You know, the reason we chose SSRIs is because those are the two things the FDA has approved for PTSD.

00:25:40 ►

And, you know, there are lots of limitations to this kind of rigid, double-blind study

00:25:47 ►

with these standardized measures. There are a lot of things that these measures don’t

00:25:52 ►

measure. There are a lot of limitations to this as opposed to more descriptive kind of

00:25:58 ►

research. But this is what it takes to get FDA approval for drugs. So this is why we’re approaching it this way.

00:26:07 ►

And I think it also, there are strengths to double-blind studies too.

00:26:11 ►

They have their own strengths, and we’re trying to capitalize on that, recognizing that there

00:26:16 ►

are lots of other questions to be asked and answered.

00:26:23 ►

Any other thoughts?

00:26:24 ►

Yeah.

00:26:24 ►

Any other thoughts?

00:26:24 ►

Yeah.

00:26:30 ►

That’s our thinking about our ultimate goal.

00:26:36 ►

Our goal with this study is to find out whether we can demonstrate that it would be worthwhile

00:26:39 ►

to study that further in order to do what you’re talking about.

00:26:44 ►

She’s mentioning getting drug approval for prescription use.

00:26:49 ►

What it takes for the FDA is you have to have Phase I studies,

00:26:53 ►

which is what Matt Baggett’s done and other, Charlie Grove has done,

00:26:57 ►

just measuring physiology in normal volunteers.

00:27:01 ►

Then you have to have Phase II studies, and ours is the first one of those,

00:27:05 ►

which is when you give the drug to people with a problem and measure the therapeutic

00:27:11 ►

effect, and you do that in a small group. Then if that phase two study is promising,

00:27:18 ►

then the FDA requires two phase three studies, which would be probably a total of at least 500 people

00:27:26 ►

in multi-centers.

00:27:27 ►

So that’s what we’re hoping, to move on to phase three, and then the possibility that

00:27:32 ►

they would approve it as a prescription medicine again, or for the first time.

00:27:36 ►

I wondered if your knowledge can be exposed to the laboratory.

00:27:50 ►

Yeah, the question in comment is about the impurity in street ecstasy.

00:27:53 ►

You know, I’m not really on top of that.

00:28:01 ►

I’m not very knowledgeable about that, what is actually in the ecstasy these days.

00:28:02 ►

It is a real concern. You know, that’s one of the tragedies about this drug policy.

00:28:09 ►

You know, people don’t get information and they don’t get,

00:28:15 ►

they don’t know what they’re taking.

00:28:16 ►

And I wish I had a better answer,

00:28:20 ►

but I think it’s something you need to be really concerned about.

00:28:25 ►

Yeah. I’m curious about the concept of something. but I think it’s something you need to be really concerned about.

00:28:35 ►

The question is about how sustainable is the effect.

00:28:45 ►

It really looks like for some people two sessions is enough to really significantly heal their PTSD.

00:28:50 ►

It looks like for other people, more sessions would be better.

00:28:52 ►

That’s why we asked for the third session.

00:28:59 ►

It seemed pretty clear that there were some people that were kind of really having some benefit,

00:29:03 ►

but it took them a while to get kind of used to the setting and the drug,

00:29:06 ►

and the third session would be helpful, and that’s what we’re finding.

00:29:08 ►

It seems that the third session is adding something.

00:29:14 ►

Now, what the optimal number of sessions is, I don’t know.

00:29:15 ►

It’s probably not three.

00:29:21 ►

You know, we started with trying to get something from the FDA. Do you say sustained?

00:29:26 ►

Well, we don’t know that either.

00:29:29 ►

You know, right now sustained means three months.

00:29:32 ►

At the three-month point,

00:29:34 ►

their symptom levels are still low.

00:29:37 ►

Now we’re going to go back and look at after a year and we’ll find out.

00:29:39 ►

Our impression is that, yeah,

00:29:41 ►

it is in at least some of the people

00:29:44 ►

that we’ve had contact with

00:29:46 ►

it looks like

00:29:47 ►

at least a lot of the effect is sustained

00:29:50 ►

past a year

00:29:52 ►

with even two sessions.

00:29:55 ►

So that

00:29:56 ►

whatever the number, that’s kind of

00:29:58 ►

the model, not that you have to keep

00:30:00 ►

using this continuously, but that

00:30:02 ►

you know, it gets

00:30:04 ►

it somehow removes the obstacles that are preventing,

00:30:07 ►

have been preventing the people from healing from their PTSD.

00:30:12 ►

And you know, the fear and problems with trust

00:30:17 ►

that are part of PTSD are also real obstacles

00:30:20 ►

to the therapy of PTSD.

00:30:22 ►

So our thinking is that this lowers levels of fear

00:30:25 ►

and increases the ability to trust

00:30:28 ►

in the therapeutic relationship.

00:30:30 ►

It may remove those obstacles

00:30:32 ►

that are preventing them from healing.

00:30:37 ►

The other thing is that, you know,

00:30:39 ►

these are people with rather severe PTSD

00:30:42 ►

who are working with their trauma.

00:30:44 ►

A couple of people

00:30:45 ►

have said, you know, I don’t know why they call this ecstasy. They’ve said, this has

00:30:49 ►

been really helpful to me, but I don’t know why they call it ecstasy, because it’s been

00:30:54 ►

really hard work. A lot of difficult emotions coming up, and if they think of it as a therapeutic

00:31:00 ►

tool, they don’t think of it as a reparation thing. In a lot of cases, it’s what it seems.

00:31:01 ►

tool, they don’t think of it as a reparation thing. In a lot of cases, it’s what it

00:31:04 ►

seems.

00:31:06 ►

Yeah.

00:31:09 ►

What our vision

00:31:10 ►

is for the long term,

00:31:11 ►

if it were to become

00:31:13 ►

prescription medicine, well,

00:31:16 ►

let’s switch chairs.

00:31:18 ►

We don’t think that

00:31:19 ►

we’re not picturing that

00:31:21 ►

doctors would write prescriptions for people to take

00:31:24 ►

home.

00:31:26 ►

We’re picturing that you would write prescriptions for people to take home. We’re picturing that you would need sort of like a methadone clinic.

00:31:31 ►

You know, you can’t just write a methadone prescription because you have a medical license and a DA number.

00:31:36 ►

You have to have a methadone clinic that’s licensed.

00:31:39 ►

So that’s kind of what we’re envisaging, is people who have a particular interest in this,

00:31:45 ►

have a certain training,

00:31:46 ►

and set up the appropriate set and setting,

00:31:49 ►

they may be allowed to use it.

00:31:51 ►

I think that would be the next step,

00:31:53 ►

the first step if it were to become legal.

00:32:00 ►

Thanks very much.

00:32:01 ►

It’s really fun to share this with you.

00:32:18 ►

I was interested in hearing Michael’s overview of the current state of investigation into the toxicity of MDMA.

00:32:24 ►

You probably remember that bogus story about MDMA causing holes in the brain that was being told by everyone from MTV to Oprah.

00:32:28 ►

So I won’t bore you with the story again.

00:32:31 ►

Even the National Institute on Drug Abuse has taken those fake brain scans off their website.

00:32:37 ►

But I will tell you this.

00:32:39 ►

MDMA was the first so-called drug that I ever tried. I was almost 42 years old,

00:32:45 ►

and at the time I was an Irish Catholic Republican lawyer

00:32:48 ►

living in Dallas, Texas.

00:32:51 ►

And at the time, MDMA was legal,

00:32:54 ►

or I doubt if I would even have tried it.

00:32:57 ►

Now today I’m still Irish,

00:32:58 ►

but I can guarantee you that I’m no longer a Catholic Republican lawyer,

00:33:04 ►

and I doubt if I’ll ever even visit Dallas again.

00:33:07 ►

So if you’re speaking with the point of view of a Catholic or a Republican,

00:33:12 ►

well, I guess you could fairly say that MDMA is a dangerous drug,

00:33:17 ►

because, hey, look what it did to Larry.

00:33:20 ►

He moved to California, changed his name to Lorenzo,

00:33:23 ►

and now he can be found hanging out in cyberspace with his friends in the psychedelic salon.

00:33:29 ►

That’s what they’re saying back in Texas these days, anyhow.

00:33:33 ►

And all I can say to my old friends is that I’m sure having a much better time than I was back when I was commuting to my little rat-like cubicle every day.

00:33:43 ►

Wow. I’m not sure where all that came from.

00:33:47 ►

What I was actually trying to get at

00:33:48 ►

was the fact that back in the early 80s in Dallas,

00:33:52 ►

none of us really knew what we were doing

00:33:54 ►

when it came to using MDMA,

00:33:56 ►

or ecstasy as it was called back then.

00:33:59 ►

By the way, the reason I don’t use the word ecstasy anymore

00:34:03 ►

is because what passes on the streets and at parties these days as ecstasy is quite often something else.

00:34:11 ►

And what we’re talking about here is MDMA, pure MDMA.

00:34:17 ►

Anyway, back then I became an MDMA abuser, big time.

00:34:27 ►

MDMA abuser, big time. I won’t go into the brutal details, but I got so out of control with my MDMA use that it eventually came to a point where even extremely large doses had no effect on me.

00:34:34 ►

And eventually I got back in control of myself and stopped using it completely. And after two

00:34:41 ►

years, I tried it again and it still had zero effect on me.

00:34:48 ►

So I laid off for another seven years before trying it again,

00:34:51 ►

and to my surprise and much to my delight,

00:34:56 ►

it was almost as powerful an experience as it was the very first time I took it.

00:35:02 ►

Now my point isn’t to expose my own stupidity in abusing this wonderful substance.

00:35:06 ►

The point is that even with very large and very frequent uses of MDMA over quite a long period of time, at least in my single instance,

00:35:12 ►

well, it didn’t seem to have any serious long-term effects on my brain. So if you’ve been using this

00:35:19 ►

magical medicine and are finding that it isn’t working like it once did, well, you might want to think about leaving it alone for a while, maybe a long while.

00:35:28 ►

But in any event, if I were you, I wouldn’t worry about having done any long-term damage

00:35:33 ►

to your brain, and for sure you haven’t burned any holes in it.

00:35:39 ►

Another question that I get from time to time in various forms comes from Stan who writes,

00:35:45 ►

Though I’ve been interested in psychedelic medicines

00:35:47 ►

for a long time, I’ve not yet

00:35:50 ►

had my first journey into the unknown.

00:35:52 ►

My question to you is

00:35:54 ►

what psychedelic is best to start with?

00:35:56 ►

I was assuming I should

00:35:57 ►

start with small doses of LSD.

00:36:00 ►

Do you think that would be a good idea?

00:36:03 ►

Well,

00:36:04 ►

Sam, in order to keep the screwheads from coming after me,

00:36:07 ►

I have to remind you that using any of the sacred medicines that are on one kind of schedule or another

00:36:13 ►

can get you into a lot of trouble with some of the less enlightened members of our species.

00:36:19 ►

And that fact alone can be the trigger for a bad trip.

00:36:23 ►

In my case, I was lucky because my first experience was with MDMA,

00:36:28 ►

and at the time it was still legal.

00:36:31 ►

And so I didn’t have any unnecessary paranoia added on top of the normal anxiety

00:36:36 ►

of doing something like this for the first time.

00:36:39 ►

And then after that, I did MDMA frequently and for a long time before trying anything else.

00:36:45 ►

It was over a year, in fact, before I got up the courage to try LSD.

00:36:50 ►

In my case, I think it would have been a bad idea for me to start out on this path with LSD.

00:36:56 ►

And are you ready for this one?

00:36:59 ►

My opinion is that the first time you use LSD, not only should it be in a safe place and with an experienced

00:37:07 ►

guide by your side, I also believe that a large dose is in order for the first time.

00:37:14 ►

Now, not many of my friends will agree with this, the large dose part that is, but I’ve

00:37:18 ►

seen more people have trouble on low doses than on high ones.

00:37:22 ►

So, go figure, huh?

00:37:22 ►

trouble on low doses than on high ones.

00:37:23 ►

So, go figure, huh?

00:37:26 ►

And I guess this points out exactly why we need studies

00:37:28 ►

like the one Michael and

00:37:29 ►

Annie Mithoffer are conducting.

00:37:31 ►

Without some systematic investigation

00:37:34 ►

like what was taking place

00:37:36 ►

in the 1950s and early 1960s,

00:37:38 ►

we are always going to

00:37:40 ►

be left with widely varying

00:37:41 ►

anecdotal advice about how to best

00:37:44 ►

use these sacred medicines.

00:37:46 ►

Although it’s a shame that we

00:37:47 ►

haven’t progressed significantly in our

00:37:49 ►

knowledge of these things since the 60s,

00:37:52 ►

I am happy to see a resurgence

00:37:54 ►

in the sanctioned research

00:37:56 ►

into the use of psychedelics and

00:37:57 ►

related substances like MDMA,

00:38:00 ►

and I’m sure it’s a

00:38:02 ►

positive sign of things to come.

00:38:05 ►

Before I go, I should mention, as always,

00:38:08 ►

that this is a podcast of the Psychedelic Salon

00:38:11 ►

and is protected under the Creative Commons Attribution

00:38:13 ►

Non-Commercial Sharealike 2.5 License.

00:38:17 ►

And if you have any questions about that,

00:38:18 ►

just click the link at the bottom of the Psychedelic Salon webpage,

00:38:22 ►

which you can find at matrixmasters.com slash

00:38:26 ►

podcasts.

00:38:27 ►

If you still have questions, just send them to me, lorenzo at matrixmasters.com.

00:38:33 ►

Thanks again to Chateau Hayouk for the use of their music here in the salon, and also

00:38:38 ►

to Michael Mithoffer, who braved the trials of the playa at Burning Man and graced us

00:38:44 ►

with his time for this interactive conversation that we just heard.

00:38:48 ►

Now before I go, I want to leave you with one final thought.

00:38:53 ►

Our Little Clans elder recently proposed that we consider doing one thing each month

00:38:58 ►

that we would still remember five years from now.

00:39:02 ►

So I now have a calendar for five years from now,

00:39:05 ►

and on it I’m marking the event from a corresponding month this year that was

00:39:09 ►

so significant that I’m sure I’ll still remember it clearly five years from now.

00:39:13 ►

And by the way, in case you haven’t done the math yet, five years from now is the

00:39:19 ►

year 2012. So how about it? Am I the only one who couldn’t come up with something significant

00:39:26 ►

enough for each of the first three months of this year so far? I did have one such perfect

00:39:31 ►

moment in March, though, and now I’m on the lookout for my memorable moment in April.

00:39:37 ►

It’s an interesting concept, don’t you think? Well, for now, this is Lorenzo,

00:39:42 ►

signing off from Cyberdelic Space.

00:39:45 ►

Be well, my friends.

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