Brian Anderson, MD MSc. October 2024

February 10, 2025

Title: Community Uses of Psychedelics and Safety (CUPS): Preliminary Results from a Multimethod Observational Study

Description: This talk presents the methods and findings of 3 observational protocols that together make up the community-engaged CUPS study (FDA BAA75F40122C00116). Ethnographic, survey, and epidemiologic data on psychedelic use in non-medicalized settings, including serious adverse events and community-based safety practices, are presented. The potentials and limitations of assessing the harms of real world psychedelic use are discussed.

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ID: 12727
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00:00So,
00:03welcome.
00:06Get started, Jessica.
00:08Yep. Perfect. Go ahead. Great.
00:10So welcome back to the
00:12seminar in psychedelic science.
00:14It's my pleasure to introduce
00:16Brian Anderson. He's assistant professor
00:19in the department of psychiatry
00:21and behavioral sciences
00:22at UCSF
00:24and conflouting
00:25investigator
00:26at the UC
00:28Berkeley Center for the Science
00:30of Psychedelics.
00:31And he's here to talk
00:34to us today
00:35about community use of psychedelics
00:38and safety.
00:40I'm hearing myself
00:42with a lot of feedback,
00:42which is distracting, so just
00:44take it away, Brian.
00:46Okay. Great.
00:48Hi, everyone, on Zoom and
00:50in person.
00:52Thanks for having me. What
00:53Julian did not say is
00:54that,
00:55we're old friends of, like,
00:57what, maybe fifteen years, and
00:58we've been trying to find
00:59ways to collaborate on science
01:01on and off for a
01:02while. So this is fun
01:04as we're
01:05and getting close getting closer
01:06to that.
01:08What I,
01:10so, originally, I think I
01:11was gonna try to come
01:13and visit the department,
01:14like, a a year ago.
01:17There were there were plans
01:18to have some sort of
01:19educational event regarding psychedelics and
01:21safety and public policy that
01:23sort of got scrapped, but
01:24we were able to, come
01:25back.
01:26And it's good timing because
01:27I have some preliminary data
01:29I'm gonna show from a
01:30study that we've been doing
01:31at UCSF.
01:33And I I'm happy to
01:35go through this, but also
01:36my first time visiting you
01:37all.
01:39You guide me on how
01:41you guys run the seminar
01:42regarding questions during discussion.
01:45We'll go through the the
01:46slides, but please, like, let
01:48me know if there's things
01:49that you guys wanna talk
01:50about as we're going.
01:52Just to get a sense
01:53of who's here, is this
01:55mostly folks from the departments
01:57of psychiatry and neurology?
02:00Or is that
02:02Just enrolled, retired It's a
02:04mix of faculty, residents, and
02:06just people in the community
02:07that are interested in psychedelics.
02:10Great. Thanks, Jessica.
02:12Alright. Well, you guys let
02:14me know what's what's on
02:15your mind as as we
02:17go.
02:19So I wanna start with
02:20disclosure. So I will be
02:22talking about non FDA approved
02:23uses of these substances, not
02:25in the sort of kind
02:26of off label prescribing
02:27clinical use, but their use
02:29out out in the community.
02:31My research support is here
02:33from government and foundation sources.
02:36I don't have contracts with,
02:38industry.
02:41And a sort of disclosure
02:43that I I like to
02:44bring up, I think, is
02:45helpful for situating
02:46just sort of my own
02:47personal perspectives on this work,
02:49but also that informs my
02:51science is that I feel
02:52like a lot of what
02:53I've learned about psychedelics over
02:55the last
02:56twenty years has been in
02:57community settings. So I've done
02:59work and got to spend
03:00time with different communities that
03:01use psychedelics in traditional ways.
03:03And I feel like a
03:04lot of what I bring
03:05to this work, as you'll
03:06see in some of my
03:07methods,
03:08comes from community engagement and
03:10learning from people with nonmedical
03:12expertise.
03:16In this talk, I'm gonna
03:18talk about some preliminary data
03:19from three observational protocols that,
03:22we are conducting right now
03:23at UCSF.
03:25We're gonna look at some
03:26ethnographic survey and epidemiologic
03:29data,
03:30focused on psychedelic harms and
03:33nonmedicalized
03:34settings
03:35with a focus on,
03:37serious adverse events and safety
03:38practices.
03:40As well as
03:42Maybe minimize this. Oh, okay.
03:45Thank you. Sorry to interrupt.
03:47Great.
03:49And then,
03:50yeah, just thinking sort of
03:52about the limitations and and
03:53benefits of of looking at
03:55real world,
03:56evidence of harms.
03:58To simplify what I wanna
04:00talk about, I'm gonna just
04:01break it down into a
04:02few topics, psychedelics and safety,
04:04a little background on that,
04:06psychedelic churches,
04:07one of our content areas,
04:09psychedelic augmented
04:11recovery from substance use disorders,
04:13and then epidemiologic,
04:15epidemiology of psychedelic harms. We'll
04:17see, you know, how much
04:19we get through together.
04:22Why study psychedelics and safety?
04:24Probably a pretty a question
04:26we don't really have to
04:27ask. There's a lot of
04:27interest in this these days,
04:29but there didn't used to
04:30be the same level of
04:31interest and discussion on this
04:33topic.
04:35About,
04:36almost twenty years ago, I
04:37was doing my first project
04:39in drug ethnography. I used
04:40to do more work in
04:41medical anthropology, and I spent
04:42time with an Ayahuasca a
04:44couple different Ayahuasca churches in
04:46Brazil,
04:47where the use of Ayahuasca
04:48has been legally protected at
04:49the federal level since the
04:51nineteen eighties. So these are
04:52established communities that have rituals
04:54and and ceremonies using this
04:56substance.
04:58At that time,
04:59the discussions regarding psychedelics, especially
05:01in the medical field, which
05:02is very different from today.
05:04Fast forwarding to work I
05:06did a few years ago,
05:07conducting a clinical, pilot study
05:09of psilocybin assisted group therapy
05:11for demoralized older long term
05:14AIDS survivors.
05:16This was my first engagement,
05:18in with clinical trials and
05:19really taught me a lot
05:20about how we assess adverse
05:22events in the clinical research
05:23setting.
05:24It showed me a lot
05:25about, you know, what actually
05:26goes into our medical knowledge
05:28of drugs, but also the
05:29limitations of,
05:31interpreting and collecting these data.
05:34This is one of my
05:34favorite parts of conducting this
05:36trial, is actually thinking through
05:38how we can understand adverse
05:39events and how we try
05:41to capture them quantitatively.
05:43Things like, for instance, this
05:45one participant in our study
05:46who had what we ended
05:47up calling a post traumatic
05:49stress flashback
05:50because I just couldn't find
05:51a better term where a
05:53few days after receiving high
05:54dose psilocybin and doing pretty
05:56well in his day after
05:58check-in with us, had a
05:59very intense visual flashback that
06:02led him very distressed. He
06:04could not go to work.
06:04He could not leave his
06:05house for a few days.
06:06He couldn't even reach out
06:07to talk to us about
06:08it, for a couple days
06:10after. And so thinking through,
06:11like, how do we detect
06:12this or how do we
06:13miss this in trials
06:14really sort of got my
06:16attention.
06:18Then as many of us
06:19know about twenty nineteen, twenty
06:21twenty, my sense is that
06:23kind of the field of
06:23psychedelic medicine just kind of
06:25took off. There was a
06:26lot more interest, research, investment
06:28in the area, and we
06:29even had states, like, for
06:31the first time, Oregon,
06:32legalizing
06:33some form of psychedelic,
06:36regulated psychedelic care. It's not
06:38actually psychedelic therapy. It's not
06:39how they regulate it, but
06:41they legalized this for adults.
06:43And that got me and
06:46some of my other, colleagues,
06:47like Charlie Grobe and Alicia
06:48Danforth, really thinking about some
06:50of the safety issues that
06:51we were not seeing emphasized
06:53like we had,
06:55in the prior years.
06:57We we wrote up a
06:58small piece about this based
06:59off of some discussions we
07:00were having with policymakers
07:02and and other scientists.
07:04And, you know, interestingly, we
07:05we kind of summarize what
07:06we thought was in the
07:07field and in our sort
07:08of clinical
07:09knowledge, sent it to a
07:10journal as a perspective piece,
07:12and they wrote back saying,
07:13you don't have enough evidence
07:14to publish this as a
07:15perspective piece. Like, you're just
07:17sort of quoting anecdotes. We
07:18can't maybe you could publish
07:19a commentary. So we ended
07:21up whittling it down, and
07:22that's what we were able
07:23to get into the literature
07:24at the time.
07:27Others have been working on
07:28this, including folks who've been
07:29in, engaged with, people here
07:31in the department, including captain
07:33Sean Beloyne at HHS,
07:35SAMHSA,
07:36etcetera.
07:37And people, I think, started
07:38to talk through, like, what
07:39is gonna happen with psychedelics
07:41are in these real world
07:42settings in Oregon and other
07:43states and municipalities that are
07:45making access more more readily
07:47available, including if there's medicalization,
07:49like an FDA approval. What's
07:50gonna happen when this is
07:51actually out in use? And
07:53so I've been, lucky to
07:55be part of some conversations
07:56and work thinking through that.
07:59When I normally talk about
08:00psychedelic harms, I normally just
08:02kinda put up a slide
08:03like this, and I say,
08:03well, I I don't have
08:04a lot of data on
08:05sort of frequency, etcetera, but
08:07we can look at trials
08:08and can say things like
08:09headache and insomnia, fatigue are
08:11pretty common. The really bad
08:12things would be things like
08:14a hybrid sounded like you're
08:17crisis.
08:18Everyone's
08:20everyone's manic or manic episode.
08:24I don't know. They'll just
08:25And Yeah. Even any side
08:27effects. I did a chocolate
08:28bag. If if if if
08:29if there can,
08:30mute her mic, that'd be
08:32great. Maybe you can Oh,
08:33it's full.
08:35Okay.
08:36But the the literature has
08:37been evolving. So, you know,
08:39these towards the top are
08:40some of my favorite citations
08:41that actually go back through
08:42the older literature and look
08:44at case reports and look
08:45at surveys of adverse events.
08:47And more recently, just twenty
08:48twenty two, twenty twenty four,
08:49we're starting to see systematic
08:51reviews that I think are
08:52more meaningful
08:53of the adverse of that
08:54events that can happen in
08:55clinical trials.
08:56But this is sort of
08:57a long way that we've
08:58come just just recently.
09:02And yet even in good
09:03systematic reviews, what we're seeing
09:04is that adverse events even
09:06happening in in well conducted
09:07trials here in the United
09:09States are not always being
09:10reported fully or maybe not
09:12being reported at all. And
09:13so there's this really helpful
09:14piece I point people towards
09:16published in the Harvard divinity
09:18bulletin two years ago by
09:19a participant in the psilocybin
09:21for depression trial who later
09:22wrote about this in sort
09:23of the gray literature detailing
09:25how she reached out to
09:26her guides. She felt like
09:27they kinda minimized her symptoms.
09:29She had sort of a
09:30prolonged impairment that went on
09:32for weeks, maybe even months.
09:33She couldn't work
09:34after the psychedelic experience that
09:36didn't quite get registered in
09:37our papers.
09:38All this just leads me
09:39to ask, like, what are
09:40we missing and what should
09:41we be thinking about how
09:42we can learn more
09:44about the downsides of this
09:45work?
09:46This led our group at
09:48UCSF,
09:50going through this process to
09:51apply for a regulatory
09:53science grant from the FDA
09:55or a contract that, this
09:56is back in twenty twenty
09:57one when we submitted.
09:59The FDA has extramural funding
10:01for various things that support
10:02regulatory science broadly. In this
10:04area, we focused on substance
10:06use disorders and patient and
10:07consumer preferences and perspectives was
10:10what we responded to.
10:12We put together a large
10:14project called CUPS, the community
10:15uses of psychedelics and safety.
10:18The these are all the
10:19co,
10:20investigators that have been working
10:21with this,
10:22on this. My co PI
10:23is Jenny Mitchell at UCSF.
10:27And to summarize what we
10:28did, we created a series
10:30of protocols that are community
10:31engaged or collaborative by nature
10:33that try to combine qualitative
10:35and quantitative methods in order
10:37to understand real world risks
10:38and benefits of psychedelic use
10:40in these nonmedicalized settings with
10:42the hope that this can
10:43inform policy and and clinical
10:45implementation down the down the
10:46line.
10:47We created these four, separate
10:50protocols that I'm gonna walk
10:51through,
10:52three of them today.
10:53We're not gonna go through
10:54CUPS four, which is a,
10:57three language online interview because,
10:58actually, after one year, the
11:00FDA cut that out of
11:02the contract.
11:03I learned a lot of
11:04lessons about trying to subcontract
11:06research to Brazil and send
11:08money abroad, which took a
11:10year to send the first
11:11check.
11:12And after that, FDA said
11:13it's not really focused on
11:15US citizens that we have
11:16to prioritize. This is very
11:17delayed, so we actually lost
11:19that.
11:19But we'll come back to
11:20that a little bit later.
11:23And then we actually designed
11:25the study to be done
11:26in consultation with the community
11:28partners. So this is a,
11:30nonprofit,
11:31public education,
11:33institute in San Francisco that's
11:34been helping us with with
11:35the research.
11:38So to break down sort
11:39of what we did in
11:40a sort of a series
11:41of questions,
11:43you know, one way to
11:44ask this is, what can
11:46we learn from religious communities
11:48where members engage in frequent,
11:51chronic, high dose psychedelic use
11:53without formal medical supervision.
11:55This is how we describe
11:56it to the FDA. I
11:57think this is a terrible
11:58way to describe a psychedelic
11:59church, but we had to
12:00sort of translate it into
12:01medical,
12:03parlance to sort of argue
12:04about why this is relevant
12:06for what we do with
12:07with medical,
12:08research.
12:10So in this protocol led
12:11by what who was a,
12:13postdoc, NIDA two thirty two
12:14funded postdoc in our group
12:16who's now actually a faculty
12:17member, out in Boston,
12:19doctor Maha Mian, a clinical
12:20psychologist.
12:22One of our aims was
12:23to first actually establish a
12:25community advisory board of,
12:27affiliates or, allies of long
12:30standing churches who've been operating
12:31in this country for over
12:32a decade that use psychedelics.
12:35We wanted to build a
12:36relationship with them, so that
12:38they could help us with
12:38our design and also access
12:40to gain,
12:41to do the data collection.
12:43And we found, six members
12:45who are aged,
12:47range from, forty to seventy
12:49years old,
12:50from all parts of the
12:51country, and whose mean number
12:54of years of experience practicing
12:56their tradition is over twenty
12:58years is the average for
12:59this group.
13:00They use a number of
13:01different psychedelic
13:02substances, and one of them
13:04even wrote us a letter
13:05of support and was part
13:06of how we designed some
13:07of the questions for even
13:08submitting the contract to FDA
13:09in the first place.
13:13What we then did as
13:14far as data collection is
13:15we really tried to understand
13:16attitudes and beliefs amongst psychedelic
13:18users in these churches for
13:20how they think about,
13:21adverse events and how they
13:22can be prevented.
13:24We involve the methods involve
13:26brief ethnographic site, visits to
13:29churches,
13:30focus groups of church leaders,
13:31interviews with church members, and
13:33then a survey we constructed
13:34to understand,
13:36the churches themselves.
13:38Something I'll just pause briefly
13:40and talk about is because
13:41this was a, federal
13:43contract and not a federal
13:45grant,
13:46We were subject to, and
13:47I didn't understand this at
13:48first, the Paperwork Reduction Act
13:50that says that any survey
13:51we do has to be
13:53go through a public comment
13:54period like any federal employee
13:56would. And so
13:58we
13:59have had some significant delays
14:00because we were not allowed
14:01to submit any of our
14:02requests to do the surveys
14:04until all of the protocols
14:06in the contract had all
14:08the paperwork together.
14:09And, that included our Brazilian
14:11colleagues who had to translate
14:12everything in English and submit.
14:14So we were pretty hampered
14:15by this rule, and that's
14:17part of the reason why
14:17some of this survey work
14:19has actually been cut from
14:20the contract.
14:21But what we have been
14:22able to do, even under
14:23the PRA, is pilot our
14:25our methods. And so we've
14:26worked with one DEA registered
14:28church. They have a DEA
14:29schedule one registration,
14:31one church that does not
14:32is not DA registered.
14:35It's been, critical just thinking
14:37through, like, how we've done
14:38this, that members of our
14:39community advisory board have have
14:41served as liaisons to bring
14:42us into the communities and
14:43introduce us to members to
14:45facilitate interviews.
14:47It's been very helpful to
14:48actually go to sites,
14:50conduct visits, meet people in
14:52person.
14:53And I'm one of the
14:54team members that has volunteered
14:55to participate in the ceremonies,
14:58which the church members often
14:59require that at least someone
15:01who's gonna be there is
15:02participating.
15:05And it also leads to
15:06very interesting conversations that sort
15:08of convey their understanding of
15:10why people should participate,
15:12not reasons of like, oh,
15:13you're not gonna understand
15:15always, but also things like,
15:17if you are around us
15:18when we're doing a ceremony
15:19and you haven't taken the
15:20sacrament, you are not gonna
15:22be spiritually protected, and we're
15:23concerned for your safety.
15:25So we're learning things about
15:26how they talk and think
15:27about safety and instruct our
15:28members by just being there
15:30with them.
15:31Alright. I have a question.
15:32Yeah. Maybe you'll get into
15:33this, but is,
15:35I I I haven't done
15:36a deep dive on the
15:37the psychedelic churches. So Yeah.
15:39Is their their taking of
15:41the secularism purely for spiritual
15:43enlightenment, or do they sometimes
15:45offer that for medicinal purposes?
15:47Or
15:48what are the purposes for
15:49you? Great. So secular church
15:51is, like, a very broad
15:53label.
15:56There are organizations that call
15:58themselves churches in this country
16:00that look much more like
16:02dispensaries.
16:04There are communities that, we've
16:06probably never heard about because
16:07they're so underground. They protect
16:09their work so much that,
16:10we're just never gonna be
16:11able to interview them for
16:12a study like this.
16:14The groups that we're going
16:15to, we've very specifically
16:17decided our inclusion criteria would
16:19be operating consistently
16:21for at least a decade
16:22in this country. Some of
16:23them have been around for
16:24since the late eighties.
16:28And they are not they're
16:30not they're not ketamine clinics
16:32trying to not be medically
16:33regulated.
16:34They really do and this
16:36is why we've chosen to
16:37have, like, a very sincere
16:38practice of, like, a spiritual
16:39community that uses these substances
16:41as sacraments.
16:42And yet it would be,
16:45it would be strange
16:46to think that there's no
16:48intention of, like, healing or
16:50therapeutic purposes in these communities,
16:52and many of them come
16:53from
16:55lineages of
16:56cyclic plant and fungus use
16:58that are very much focused
17:00on types of healing.
17:01But that maybe looks differently
17:03than how we conceptualize, like,
17:04medical treatment and therapeutic uses
17:06in North America today.
17:09If that
17:10there's there's a variety. We're
17:11focused on folks that look
17:12more like churches.
17:15That includes, like, Native American
17:17churches? Or
17:18they want to. So I
17:20mean, we're working working with
17:21communities that have different
17:24sacraments.
17:25We specifically did not include
17:27Native American church in this
17:29study because we just for
17:31historical political reasons, they're really
17:32kind of separate. They're sort
17:34of regulated differently, and they're
17:35they have, like, a different
17:36sort of makeup of some
17:38of what they do.
17:40And we actually tried to
17:41get a tribal advisory committee
17:44from the HHS to talk
17:46to us about engaging with
17:47NEC churches.
17:49We couldn't even find a
17:50TAC that had the bandwidth
17:52to talk to us. We
17:53went to FDA's TAC, NIH's
17:55TAC, and SAMHSA has their
17:56own tribal advisory committee. We
17:58ended up just not doing
17:59a formal consultation with with
18:01native leaders, but we've worked
18:02with groups that probably
18:05are
18:07from, South America or Latin
18:09America in in origin so
18:10far.
18:16Just to get to some
18:16of the qualitative data, you
18:18know, summarizing,
18:19this is, like, from one
18:20interview focused on screening and
18:22safety.
18:24Jump.
18:25So we had someone last
18:27year who, almost had every
18:29red flag you can think
18:30of.
18:31I spoke with this person
18:32multiple times. I spoke with
18:34their therapist,
18:35and there were so many
18:36contraindications.
18:38And the person over multiple
18:39meetings with myself and then
18:41talking to other leaders in
18:43the church, we ultimately decided
18:44that this person could come
18:46to the ceremony.
18:48Her therapist is kind of,
18:49like, in the biz
18:51of psychedelic therapy,
18:53shall we shall we say,
18:54and the therapist also attended.
18:56And so
18:58there there are really strict
18:59guidelines that this person would
19:00be given very, very small
19:02amounts
19:03of the sacrament
19:05and would just be in
19:06the space first and not
19:07go for it.
19:08And and they did so
19:10well. It was good for
19:11them, and they're getting off
19:13their meds. So sometimes the
19:14contra contraindications
19:16are in your face, but
19:17you do it anyway just
19:18because you get, I don't
19:20know. But that's so rare
19:22that we do that. That's
19:23the one time I can
19:25remember we actually sort of
19:26took a chance.
19:27But there were a lot
19:29of conditions in place. The
19:30person's parents and siblings and
19:32everyone supported what they were
19:33doing, so we had a
19:34huge network of support for
19:35the person.
19:37But, otherwise, yeah, if need
19:38be, if it if there
19:40are questions, I'll talk to
19:41people.
19:42They have to let me
19:43talk to their therapist and
19:44make sure that they have
19:45adequate follow-up.
19:46So this is someone in
19:47one of these churches that
19:48does a lot of the
19:49screening of people before they're
19:50allowed to come.
19:53Some things I wanna highlight
19:54just from this one interview
19:56alone, you know, they have
19:57a structured health screening that
19:58they do, in this case
19:59with anyone who's who's coming
20:00to the church.
20:02This person was in, getting
20:03collateral from care providers outside
20:05of the church, and even
20:06collaborating with them. They invited
20:08the person's therapist to come.
20:09She emphasized that. I don't
20:10think that's always the case,
20:12but they did that in
20:13this sit in the situation.
20:14She's referring to established guidelines
20:16and contraindications that they have
20:17figured out that they follow
20:19for screening.
20:20And they even, you know,
20:21did consultation with other leaders
20:23before making an exemption to
20:25who they allowed to come,
20:26and then they followed up
20:27to see how the person
20:27was doing.
20:30Another quote,
20:34and dine
20:35here refers to this sacrament
20:37in this church, so from
20:38the Santa dine, Brazilian Ayahuasca
20:40Church.
20:41So the quote is, what
20:42I do is when I
20:43drink Daimi, it's kind of
20:45an act of faith, and
20:47I always ask for protection.
20:49It's really important that I
20:50stay grounded in myself because
20:51one of our Daimi teachers
20:53said that if you're not
20:54in your house, someone
20:56will be happy to step
20:57in.
20:58This church has a practice
21:00of,
21:02summoning spirits, and they do
21:04incorporation where it looks sort
21:05of like a,
21:07spiritist.
21:09They,
21:10they they start speaking in
21:11tongues, and they say that
21:12someone has taken them over.
21:15It goes on,
21:16and fear can intercede and
21:17interrupt that sometimes. So my
21:19goal each time is to
21:19cultivate the calm
21:21and the knowing that everything
21:22is fine and I'm protected,
21:24and I can call it
21:25in for for protection beings.
21:28I think one crutch of
21:29being a guardian and and
21:30often being the head guardian
21:31is that in Daimy, we
21:32believe that there's a guardian,
21:34that will that will kind
21:36of work.
21:37When we're the guardian, we
21:38call it in, and it
21:39helps
21:40us and protects us. So
21:42that's an easy go to
21:43for me to remember. And
21:45so when I'm being guardian,
21:46I can call a little
21:47bit of help.
21:48And I think it's a
21:49it's a little bit of
21:49a crutch that I volunteer
21:51to be guardian more. I
21:52can stay busy and not
21:54freak out ever if I'm
21:55starting to feel that.
21:58To break this down a
21:59little bit, guardianship is a
22:00particular concept in this church.
22:02People have get assigned a
22:04role during a large group
22:05ceremony. Certain people are guardians
22:07where they actually stand around
22:09the rest of the people,
22:10and they're there to protect
22:11them spiritually is the function.
22:14It really involves, like I
22:16said, it's an act of
22:16faith. They're praying for protected
22:18spirits. And what I found
22:20really interesting is here you
22:21have some of the people
22:23assisting in a ceremony. They
22:24are taking the Ayahuasca as
22:26well, but they're there to
22:27sort
22:28of guide and per and
22:30keep safe other people, and
22:32yet they freak out too
22:33sometimes. They're talking about how
22:35they
22:36even being in charge of
22:37others to prevent themselves from
22:38having a challenging experience,
22:40will call in
22:42a spirit to help them
22:43stay calm.
22:47So a bit of a
22:48summary from what we're seeing
22:49here.
22:51We are having some discussions
22:53of serious adverse events that
22:54happen in these communities. Again,
22:55this is all qualitative as
22:56we're not trying to come
22:57up with prevalence,
22:59but they do basically say
23:01that these are very rare
23:02if they happen at all.
23:03They do acknowledge that they
23:04certainly can
23:05occur. And what's really interesting
23:07is hearing
23:08church leaders talk about how
23:10they're concerned about safety issues
23:11in the medical setting and
23:12the state regulated settings like
23:13Colorado and Oregon.
23:15They talk about concerns of
23:16the people who are providing
23:18psychedelics, including in our clinical
23:19trials, don't have the experience
23:21requisite to do that safely,
23:23and we're doing it without
23:24spiritual safety practices that are
23:26important for them.
23:28We're hearing sort of or
23:30sort of local perspectives on
23:32on risk.
23:33Spiritual protection is a reality
23:35that is spoken very clearly
23:37about many from many of
23:38our respondents.
23:40The idea of having, like,
23:41harm harm reduction discussions doesn't
23:43make sense to a lot
23:44of people. They say there's
23:45not harm here. This doesn't
23:46harm you.
23:48There's some interesting techniques we're
23:50learning about. One experienced leader
23:52who said that when someone's
23:53really having a hard time,
23:55you actually give them more
23:56of the substance because that
23:57gives them spiritual strength so
23:59that they can sit up
24:00in their chair.
24:01And I've heard other people
24:02talk about this in ceremonial
24:04settings.
24:05And then we're finding other
24:06sort of interesting themes that
24:07actually doctor, Neon is following
24:09up now about the role
24:10of using sacraments while people
24:12are pregnant and how that's
24:13talked about in these communities.
24:20That's the church part. I'm
24:22gonna keep going unless anyone
24:23stops me with questions.
24:25Okay.
24:26Next question that I have
24:28that I'm thinking through is,
24:31moving away from more established
24:33religious
24:34communities to
24:36kinda getting at your question,
24:37Manuel. What about people who
24:38are using this for kind
24:39of therapeutic healing reason, reasons?
24:41What does that look like
24:42in different settings?
24:43So we've really focused in
24:45on a particular context, and
24:47we wanna we're asking what
24:48can we learn about mutual
24:49aid communities where people are
24:51seeking,
24:53help with addictions through combining
24:56twelve step fellowship work with
24:58intentional psychedelic abuse.
25:01Many people would say, wait.
25:02You can't do that. That's
25:03sort of against the rules.
25:05But there's a a whole
25:06thriving sort of growing
25:08subcommunity of twelve steppers that
25:10are engaging in this practice,
25:11and we partnered with them
25:12to evaluate that and learn
25:14about it.
25:16So this work is led
25:17by, doctor,
25:18Nikki Mitani, who's an addictions
25:20and HIV specialist in our
25:22group at UCSF,
25:23also was a NIDA t
25:24thirty two post doc and
25:25recently joined the faculty.
25:27One of the aims is
25:28to understand just the motivations,
25:30benefits, harms that can be,
25:32found in this practice, specifically
25:34of people who are at
25:35least using Ayahuasca, if not
25:36other psychedelics, and combining that
25:38with twelve step work.
25:40This involves surveys and semi
25:41structured interviews,
25:43which actually doctor Egan Lebas
25:44has been helping us in,
25:46analyzing.
25:48Everyone has to have an,
25:49history of either alcohol use
25:51disorder, opioid use disorder, or
25:52stimulant use disorder, often combinations.
25:56And they self report that
25:57they did not receive benefit
25:58from conventional treatments for addictions,
26:01but they have been engaged
26:02in these communities.
26:03Like the prior protocol, this
26:05also involves partnering with community
26:07members. So we have,
26:09teamed up with three men
26:10who combined have decades of
26:11experience of combining twelve steps
26:13with psychedelics for their own
26:15use and for helping others
26:16spread around the country.
26:21And one part of this
26:22is, we wanna sort of
26:23understand
26:25how how these are being
26:26combined. What does that look
26:27like? What is sort of
26:28like the logistics and and
26:29operations of that from our
26:31interviews?
26:32Again, also with some delays
26:33from the paperwork reduction act,
26:35we've been piloting this so
26:36far.
26:37We've spoken to seven individuals
26:39engaged in this practice.
26:41We couldn't interview one person
26:42who was who we wanted
26:44to because they had actually
26:45died after when relapsing,
26:47at one point, but we
26:48were able to speak with
26:49a family member who kind
26:50of told us about this
26:51person's course. And then a
26:53family member of a living
26:54respondent, we sort of got
26:55some triangulation of data.
26:59Brief summary. Most of our
27:00participants,
27:01were,
27:02white men,
27:04or non Hispanic. Many of
27:06them reported,
27:08reported histories of depression, anxiety,
27:10PTSD,
27:12and a high rate, on
27:13ACEs
27:15adverse childhood experiences.
27:17This bar graph tells us
27:19a little bit about when
27:20we ask them now looking
27:21back over their life using,
27:23SCID, five criteria, what conditions
27:26did you qualify for previously?
27:29I don't know. Let's focus
27:30on alcohol on the left
27:31just to kinda break this
27:32down. So,
27:34of the,
27:36of our participants,
27:38people had a history of,
27:40alcohol use disorder,
27:42all of them. And when
27:44we asked them about which
27:45of the criteria did you
27:46meet, the max is eleven.
27:48So, actually, the average was
27:49that all of them met
27:50eleven criteria, had a a
27:52full score, and the average
27:54duration of alcohol use disorder
27:56of the people who responded,
27:57yes, was almost thirteen years.
28:00And so you see that
28:01we're positive for a number
28:02of different substance use disorders
28:04in the small pilot sample.
28:09The number of and types
28:10of different twelve step groups
28:11that people are going to,
28:12the most common is actually
28:14Alcoholics Anonymous.
28:15There is the sub branch
28:16that is referred to psychedelics
28:18and recovery or psychedelic recovery
28:19where people also are attending
28:21meetings, but a number of
28:22them are going to AA
28:23meetings. And as we're finding
28:24out, just not talking about
28:25their psychedelic use.
28:29We got some qualitative data
28:31on, also, one, harms,
28:33from engaging these practices. One
28:35of our experienced,
28:37members said that,
28:38once he was learning to
28:40brew on his own, meaning
28:42he was cooking Ayahuasca in
28:43his mom's kitchen,
28:45and he accidentally overdosed, with
28:47it on an occasion.
28:49He said it was really,
28:50really hairy.
28:51I felt the acceleration of
28:53the experience until I started
28:54getting scared because it was
28:55so powerful.
28:58It was about three hours
28:59later. Basically, you know, I
29:01checked out. My mom came
29:02home. I was talking to
29:04myself like some kind of
29:05psychotic
29:06state.
29:06So this is, you know,
29:08very DIY, and people will
29:10make mistakes
29:12at times.
29:13When we ask them, quantitatively
29:16about, you know, acute effects
29:18that they've had, a number
29:19of them, again, out of
29:20the,
29:21seven we are able to
29:22interview, reported having pain and
29:24discomfort during the experience,
29:26revisiting traumatic memories with almost
29:28all of them,
29:30having some distress, paranoia.
29:32And this one quote is
29:33kind of indicative.
29:35It kicked my ass in
29:37the perfect way. So, yeah,
29:38Ibogaine,
29:39which
29:40is a psychedelic used to,
29:42interrupt opioid addictions sometimes in
29:45not with FDA approval, but
29:47used anyway.
29:48Ibogaine got dark. Got really
29:50dark,
29:51but it was me in
29:53my own darkness, and it
29:54was perfect.
29:56It terrified me.
29:58We asked, well, did you
29:59find that helpful? And they
30:00said, one hundred percent yes.
30:02So helpful, but also sometimes,
30:05distressing experiences.
30:07And one thing I found
30:08really helpful in looking at
30:09some of these data is
30:10we asked people,
30:11how did,
30:13engaging in this practice combining
30:14twelve steps with psychedelics,
30:16how did that support your
30:17step work? And we broke
30:19it down by steps, and
30:20they had lots of things
30:20to tell us about the
30:21different types of of work
30:23they were doing. We
30:25so the light blue bars
30:26that are at the top
30:28show,
30:30people who said that they
30:31wouldn't have been able to
30:32do that step at all
30:33had they not been doing
30:34this combination. And, again, a
30:36number of these people had
30:37been had been trying twelve
30:38steps, sometimes repeatedly, before they
30:40actually combined it with psychedelics.
30:42So we had a few
30:43people said they couldn't even
30:44get started,
30:45and they never would have
30:46been able to do step
30:47two and step three. So
30:49it
30:50oh, sorry. So this is
30:52dosing before each step, or
30:54it's,
30:55so how the use is
30:56being So when when people,
30:59are are you familiar
31:01with the twelve step?
31:03No. The twelve step. Yeah.
31:04Yeah. I mean, so people
31:05the
31:06the
31:07order and the length of
31:09time that people do their
31:10steps varies.
31:13What this is asking about
31:14is not like, okay. You
31:15go to a ceremony and
31:16then you do step three.
31:17You go to a ceremony
31:18and then you do step
31:19four. They were
31:20engaged in these communities. Their
31:22sponsors are engaged with them
31:24with this work. They were
31:24doing this longitudinally,
31:26and they were doing the
31:27steps kind of at their
31:28own pace.
31:29But, you know, from people
31:30I've worked with as a
31:32psychiatrist to say, like, I
31:33could just never get past
31:34step three. Like, I tried
31:35it, and I just couldn't
31:36I couldn't do that work.
31:37Yeah. But in terms of
31:39timing, so Yeah.
31:41Where is the cerebral people?
31:43Like, I engage the same
31:45thing. Three.
31:46I'm trying to put, like,
31:48timeline. Then Okay. I put
31:49down at the seven. Yeah.
31:51With
31:52with this
31:53Mhmm. Pilot sample,
31:55it was pretty variable. It
31:56wasn't it wasn't a pre
31:58specified protocol.
32:00So, conceptually,
32:01they said, but,
32:03you know, I could not
32:04do it. Yeah.
32:06But Yeah. Or some of
32:07them had tried previously and
32:08then given up advancing in
32:10the steps, but they went
32:11back and they were able
32:12to advance this time that
32:13they started
32:14this type of twelve step
32:15work.
32:17Step two, if I remember
32:18correctly, is, like, surrender to
32:20the higher power.
32:21And so it's something that
32:23you go through, but, you
32:24know, it's it's,
32:27you can complete a full
32:28time step program and never
32:29actually have accomplished step two
32:31in parts.
32:33I have a similar question
32:34in terms of how many
32:36times did the did the
32:37patient's dose and at what
32:39doses and Mhmm. On a
32:41similar that all these people
32:42just do once.
32:44Yes. And or were they
32:46making it themselves? Were they
32:47getting it through
32:48friends? What was the source
32:50of the time work?
32:53So I took I took
32:54some of
32:55those slides out that kinda
32:56broke it down, but I
32:57can I can tell you
32:58that,
32:59this was very helpful for
33:00us to kinda ask about
33:02how how did you combine
33:03and what was the sort
33:04of operationalized
33:05form of this?
33:07Some of these folks
33:09had,
33:11been in twelve steps already
33:12and had been sober for
33:14one year, sometimes more than
33:16that, but they'll but they
33:18shared things like, I just
33:19couldn't I still couldn't feel
33:21good. I wasn't happy. I
33:22was still suicidal.
33:24And then adding the psychedelics
33:25later helped me live a
33:26more full life or
33:28be a better sponsor, things
33:29like that.
33:32Some of them were
33:34some of them had not
33:35been able to engage in
33:36the twelve steps, but then
33:38starting this,
33:40they then went through. So
33:41there there was variability there.
33:43We had some folks who
33:46maybe only use the psychedelic
33:48one to four times a
33:49year
33:50and did that sort of
33:51intermittently. And I think there
33:53was at least one at
33:54least one respondent who said
33:55that they were doing it
33:56almost monthly.
33:59A common setting in which
34:00people were using psychedelics
34:02were actually
34:04going to a Saint du
34:05Daimy church.
34:07The Daimy church actually meets
34:09twice a month,
34:10but I don't think our
34:11respondents were going that frequently
34:13as, like, full members, but
34:14they were going with some
34:15regularity to a local community.
34:18And it and it varied.
34:19But there's people were using
34:20ibogaine
34:21and psilocybin
34:23and other things. But at
34:24least the thing they had
34:25in common was
34:26ceremonial use of Ayahuasca
34:28as regarding the psychedelic use.
34:34Just to sort of flesh
34:35out, like, what did this
34:36feel like or what did
34:38the respondents say about these
34:39processes. So for even just
34:41getting started with the twelve
34:42step, for me, the twelve
34:43steps alone were really a
34:45nonstarter.
34:46I just did not have
34:47the honesty, open mindedness, and
34:49willingness to actually do them
34:52prior to to this.
34:54And the other person said,
34:55I thought it was different
34:56from everybody in my residential
34:58treatment program. Honestly, better I
35:00was better than everyone there.
35:01And then in that Ibogaine
35:03experience, I just got
35:05I got cracked so open,
35:07and then I went to
35:08treatment, and it all landed.
35:10And I started really just
35:12to open up to the
35:12twelve step stuff.
35:14This is sort of the
35:15kind of the qualitative route
35:16data we're getting on how
35:18and why.
35:19Step two, as as Julian
35:21pointed out. Step two in
35:23in these programs is I
35:24came to believe that a
35:25higher power could restore us
35:26to sanity.
35:29So you can take step
35:31one.
35:32It was clear that my
35:33life was unmanageable, and I
35:34could not continue doing these
35:36things. But step two was
35:37a giant hurdle. You know?
35:39I came to believe that
35:40a power greater than me
35:41could restore me to sanity.
35:43I never believed that.
35:45And all of a sudden,
35:46I believed it. And all
35:47of a sudden, I believed
35:48it was such sufficient force,
35:49I devoted myself to the
35:50rest of the steps. I
35:52think actually number one is,
35:53submission to a higher power,
35:54and then two is
35:56I'm unmanageable. Yeah.
36:00So and, again, this is
36:01like a I'm just giving
36:02you slices of the different
36:04protocols to give a flavor
36:05of the type of work
36:06we've been doing. Doing. But
36:07some just some takeaways here.
36:09You know, again, like the
36:10last protocol, working with community
36:12partners has been very essential.
36:13It's really facilitated recruitment and
36:15the data collection. We actually
36:16have a wait list of
36:17people who've been signing up
36:18because they wanna be interviewed,
36:20but because of the PRA,
36:22which I we just got
36:23relieved from within the last
36:25few weeks, we hadn't been
36:26able to talk to them
36:27yet. So we're now moving
36:28forward with the rest of
36:29the data gathering.
36:30And we have to keep
36:31in mind, we have such
36:32a wait list of people
36:33because there is sometimes an
36:35evangelical
36:36sort of motive for passing
36:38on the message and sharing
36:39the story. And so this
36:40is part sort of it
36:41is coloring the data we're
36:42getting as their
36:43religious,
36:45you know, inspiration to to
36:47tell how this could be
36:48good for you.
36:52It it does seem like
36:53for some people that certainly
36:54the twelve steps and the
36:55twelve traditions, people don't talk
36:56about the traditions, but that's
36:58an important part of these
36:59practices, may actually synergize very
37:01well for forms of psychedelic
37:03healing or care that happens
37:04in these community settings.
37:07And, you know, we're seeing
37:08these sort of novel inventions
37:09of of care that honestly,
37:11when you talk to people
37:12and say, like, how can
37:13you use psychedelics
37:14and be in a abstinence
37:16focused recovery program? They say,
37:18no. It actually makes sense.
37:19I am absent from all
37:20the others, and their interpretation
37:22of that is
37:23is supported by having peers
37:25engaged in this process.
37:28It's also helping me understand
37:29some of the, you know,
37:30what are their when we
37:31think of okay. So we've
37:32seen, like, the Bogencitz twenty
37:33twenty two paper about how,
37:35you know, we can improve
37:36alcohol use disorder. How do
37:37we really translate that into
37:38community settings?
37:40It it was, helpful for
37:42me to see that actually
37:43some people were already in
37:44the twelve steps and were
37:45already sober
37:46before they started this. This
37:47is not
37:48they couldn't get sober and
37:50then psychedelics made that happen.
37:51It's actually they're saying it
37:52maybe fortifies sobriety
37:54and their path that they
37:55already started, and these might
37:57be different pathways towards combining
37:59these for people in the
38:00future.
38:05K. Gonna go to our
38:06our last section,
38:08and then, yeah, make sure
38:09we have time for just
38:09more open discussion.
38:12The question here is, you
38:13know, what can we learn
38:14from epidemiologic
38:15data on psychedelic related harms?
38:17And, specifically, how do we
38:19meaningfully interpret these signals of
38:21harm?
38:24So one way, we've been
38:25trying to think about this
38:26and approach, like, from, you
38:27know, these population level datasets,
38:29what can we learn about
38:30this is, first off, we
38:32need to be able to
38:33have estimates if we want
38:34to evaluate, for instance, like,
38:36the implementation of of Oregon
38:38where they rolled out psilocybin
38:40services. People wanna know, how
38:41does that affect public health?
38:42What's what's the outcome? Well,
38:44first, we have to know
38:44what is people's recent,
38:46for instance, psilocybe
38:49cubensis or other psilocybe species.
38:51How do we know that?
38:54Then we have to find
38:55a way to, estimate the
38:56incidence of psychedelic related serious
38:58adverse events. That's what I
38:59am focusing on. Hospitalizations,
39:01deaths, other, you know, serious
39:03impairment from the psychedelic use
39:04in a given period of
39:05time.
39:06And then how do we
39:07actually come up with, like,
39:08an absolute
39:09risk? You know, we wanna
39:10know what are the the
39:11the incidence of the serious
39:13adverse events relative to use.
39:15Because if we're having increased
39:17adverse
39:18events, but use is sort
39:19of increasing at the same
39:20time,
39:21does that tell us that
39:22it's getting riskier or not?
39:24Maybe we're gonna have
39:27more and the
39:28number of serious adverse events
39:30in Oregon hospitalizations instead of
39:32rural go up. But if
39:33the total number of people
39:34using mushrooms
39:36increases much more,
39:38is the practice safer because
39:39it's in service centers versus
39:41out in the community? These
39:42are the sort of questions
39:43we need to try to
39:44think through with data.
39:46And so in a study
39:47in a project like this,
39:49it may not be so
39:50easy, but did you have,
39:51like, a a a control
39:53group in some way? Like,
39:54ask people who were getting
39:56the twelve steps but work
39:57during psychedelics because and especially
39:59when it comes to adverse
39:59events, adverse events can happen
40:01to anybody.
40:02And, you know, part of
40:03the, documenting adverse events whether
40:05you thought it was actually
40:06related to the treat to
40:08the drug or
40:09not. And,
40:10you know, you can sometimes
40:11hear people who dose, but
40:13then weeks or months later,
40:14something happens and you wonder,
40:15was it from there? Was
40:17was that gonna happen anyway?
40:18So,
40:19was there some kind of
40:20control?
40:23So
40:23so going back
40:25to the churches, going back
40:27to this twelve twelve step
40:28communities, we're not trying to
40:29come up with,
40:30estimates of of of an
40:32incidence, you know, how frequently
40:34in this particular setting. This
40:35is all qualitative, mostly interview
40:37data. So we're really sort
40:39of taking people's word, and
40:40our goal is more to
40:41understand
40:42the descriptive parameters
40:44of the types of events
40:45that people will talk to
40:46us about.
40:47Knowing that I think
40:49we're getting better descriptions because
40:50we're using these community partners.
40:52And if we just showed
40:53up, like, with the microphone
40:54and said, can you tell
40:54us about bad things that
40:55happened here?
40:56When these are communities
40:58that have
40:59faced, you know, legal penalties,
41:02and I'll say, one of
41:03the churches that we went
41:05to has a DEA registration
41:07because the DEA,
41:09raided them in the nineties.
41:10They took them to court
41:11and then now have a
41:12DEA registration, but they literally
41:14one of the leaders had
41:16federal agents with guns in
41:18their home. And so the
41:20the sensitivity regarding having some
41:21of these conversations is is
41:23very real still to this
41:24day even for few folks
41:25who
41:26have federal
41:28license to to do this.
41:30So we we weren't using
41:32those settings to come up
41:33with,
41:34as sort of population level
41:36estimates.
41:37Moving into
41:39these larger datasets, great. So
41:41how do you actually come
41:41up with controls and understand
41:43meaningfully what what does this
41:45mean if you see a
41:45change?
41:47This is the work we're
41:48actually trying to figure out
41:49because people haven't really done
41:51this in so much
41:53psychedelic uses in these unregulated
41:55settings.
41:56We just don't even know
41:57what the,
41:58denominator is.
42:00And that's what we're trying
42:01to piece together with different
42:02datasets.
42:07So this this protocol, cups
42:09three,
42:11co led by, two of
42:12our emergency department,
42:14physicians at at UCSF, Juan
42:16Carlos Montoy and Ralph Lang,
42:19really focuses on understanding,
42:22harms,
42:23that
42:24rise to the level of
42:25needing medical attention or, toxicology
42:28consultations.
42:30And really this work that
42:31we proposed to the FDA
42:32was just to try to
42:33build an infrastructure to try
42:34to, you know, address this
42:35question. Like, how do we
42:36actually interpret this and make
42:38sense of it?
42:40Our goal is ultimately be
42:41to be able to put
42:42the pieces together and look
42:44at,
42:46changes in harm associated with
42:48policy change
42:50using the Oregon the state
42:52of Oregon model as our
42:54as our crucible for figuring
42:55out how we can do
42:56that,
42:57and then
42:59building our analytical framework on
43:00on top of that.
43:03Stopping and, just thinking about
43:05Oregon and what that, what
43:07hap has happened there last
43:08few years.
43:10Does anyone feel like they
43:11have a good sense of
43:12what's going on there?
43:15It's it's been complex. There's
43:17been different laws. The laws
43:18have been changing, but, essentially,
43:19in in twenty,
43:21twenty,
43:22the citizens of Oregon voted
43:23for two ballot measures, measure
43:25one zero nine and measure
43:26one ten.
43:27One ten went into into
43:29effect rather quickly. That decriminalized,
43:31the possession and use of
43:33of substances, multiple substances, not
43:34just psychedelics.
43:38We also know that the
43:39pandemic hit. We also know
43:40that fentanyl really sort of
43:41started raging on the West
43:43Coast. As an emergency department
43:45psychiatrist, I can tell you
43:46it was terrible. Fentanyl, meth,
43:48everything just seemed to get
43:50really bad in twenty twenty,
43:51twenty twenty one.
43:54And we had decriminalization happen
43:55at the same time in
43:56Oregon.
43:58The voters also approved measure
44:00one zero nine. One zero
44:01nine said that the state
44:03would stand up
44:05state regulated psilocybin
44:07services for adults,
44:09not psychedelic therapy,
44:11not,
44:13something that you need a
44:14diagnosis,
44:15to to receive. You just
44:17have to be a consenting
44:18adult who didn't have some
44:19very minimal,
44:21health conditions.
44:22You can not be not
44:23intoxicated, not pregnant,
44:25not psychotic,
44:26essentially.
44:27And you could qualify for
44:29receiving psilocybin mushroom products that
44:32were, grown
44:33and formulated in the state,
44:35analyzed for the, for their
44:37content of psilocybin,
44:39and then, administered only in
44:41a structured setting of a
44:42psilocybin service center.
44:45This law didn't go into
44:46effect until twenty twenty
44:48three.
44:50And
44:51the,
44:54counts of number of people
44:55who've been through this are
44:56actually kind of hard to
44:57get because the state at
44:59this point has been tracking
45:00the number of products sold,
45:02but the products can be
45:04sold in, like, equivalents of
45:05I think it's, like, maybe,
45:06like, five or ten
45:08milligram equivalents
45:10of what we think synthetic
45:12psilocybin is,
45:14and someone might get multiple
45:15products.
45:16So our estimates of the
45:18number of adults that have
45:19gone through this are based
45:20off of the number of
45:21products sold, and people are
45:22getting
45:23what what I'm being told
45:25is kind of on the
45:25range of the equivalent of,
45:27like, thirty milligrams of synthetic
45:29psilocybin. And often for people
45:31who are on or have
45:32recently been on serotonin reptic
45:35inhibitors,
45:35they're getting more of the
45:36equivalent of, like, fifty milligrams
45:38of synthetic
45:40as determined by the label
45:41on this product you get
45:42in this
45:44place. It's just GMP
45:46regulated.
45:48Maybe almost GMP,
45:50but maybe not.
45:51Somebody's been there. I think
45:53No. I mean, they have
45:53regulated labs that are analytical
45:55labs that are testing it.
45:57But but, you know, these
45:58are natural products, and then
45:59how is the testing?
46:01What's the what's the shelf
46:02life? What's the sustainability of
46:03the product? There's, like, lots
46:05of questions that I'm sure
46:05the FDA would be just
46:07have lots of, yeah, questions
46:09about.
46:11And it took,
46:13a push later to pass
46:15another state law that said
46:17that there will now be
46:18more standardized data collection in
46:20the state where each of
46:21the service centers will aggregate
46:22the data and then send
46:23it to
46:24OHSU
46:25and Oregon Health Authority to
46:27then sort of map out
46:29number of people and really
46:30hopefully track more things regarding
46:32demographics,
46:33adverse events, etcetera.
46:37Catch up to our current
46:39year twenty twenty four, a
46:40decriminalization of drugs ended. They
46:41passed an allow to take
46:42that away. And so when
46:44we wanna look at policy
46:45change, it got very
46:47tricky
46:48when not only did we're
46:50laws starting and ending and
46:51people were having access to
46:52psychedelics not in the service
46:54centers,
46:55and then
46:56county by county and city
46:58by city, different municipalities
47:00were opting in or out
47:01of the law. Our ability
47:02to we had this great
47:03plan to do, like, a
47:04difference in difference design,
47:06and, we've we've had to
47:07sort of step back and
47:08think about analytically how can
47:09we even approach this.
47:12But we are still trying
47:13to figure out some basic
47:15things. So for instance,
47:17and I'll I'll wrap up
47:18briefly, but
47:20to even try to get
47:21a denominator for the number
47:22of people who've used psilocybin
47:24in the last year, we
47:26can look to NSDUH. So
47:27the, National Survey on Drug
47:29Use and Health from SAMHSA,
47:32is conducted with a,
47:34proportionally
47:35or a weighted sample. So
47:36it's nationally representative
47:38of
47:39US,
47:41people living in the United
47:42States twelve years and older.
47:45The methods have had to
47:46change a little bit, because
47:47of COVID in twenty twenty
47:48and twenty twenty one.
47:50But NSDUH asked about hallucinogen
47:52use, meaning psychedelics and dissociatives.
47:55They ask about
47:56lifetime and past year use.
47:58Unfortunately, for psilocybin, they only
48:00talk about lifetime use. They
48:02they're going to add past
48:03year psilocybin use in twenty
48:05twenty five data, but we're
48:06not there yet.
48:08And so we have this
48:08funny puzzle where if we
48:10wanna understand last year's psilocybin
48:11use, you can't get it
48:12from this data.
48:14But what we did is
48:15we looked at everyone who
48:17said that they used a
48:18hallucinogen in the last year.
48:22Anyone who and then when
48:23they ask you about what
48:24hallucinogens you've used, the only
48:26drug that they said yes
48:27to was psilocybin.
48:31And and there's also there's
48:32a question about,
48:35I can't remember all the
48:36permutations, but, essentially, you can
48:38use the variables that exist
48:40to sort of come up
48:41with a new variable, which
48:42is for people who have
48:43used for the first time
48:45in the last year. They
48:46they ask you what was
48:47your the first year of
48:48use for different categories.
48:51So we've we've created this
48:52variable that allows us to
48:53assess only people who are
48:55starting to use the drug
48:56for the first time in
48:57the past year, which actually
48:59I think is interesting.
49:00My guess is that these
49:01are people who may be
49:02at higher risk. They don't
49:03have experience with the substance.
49:05They don't maybe are not
49:06as connected to communities that
49:07know sort of safety practices.
49:09They're initiates in SAMHSA's,
49:11language or they're,
49:13exposed to it for the
49:14first time. We tracked we
49:15tracked that over time. So
49:17the the survey doesn't differentiate
49:19without the service side of
49:21the police. People that take
49:22it to have the sort
49:24of experience
49:26of my for those. We
49:27don't know that.
49:28I know.
49:29I know. Yeah. We don't
49:30know anything about the dose.
49:31We don't know any was
49:32it actually psilocybin? This is
49:34their self report. But just
49:35to try to get
49:37those data, we've we've done
49:39this work. And and if
49:40we look and we break
49:41it down by
49:43age group,
49:44it looks like psilocybin use
49:47is increasing quite a bit
49:49over the last few years,
49:50especially in the eighteen to
49:51thirty four year olds.
49:53And yet we have to
49:54be really clear, we can't
49:55really treat this as a
49:56trend because the way that
49:57the methods changed during COVID.
49:59So we can start that
50:01trend anew,
50:02but we can start to
50:03track
50:04initiation of use in the
50:05last year. And we can
50:07compare that to other drugs
50:08like LSD
50:10and MDMA
50:12and try to just get
50:14a sense of recent use
50:15using nationally representative data.
50:19Even better, we can look
50:20to the Rand Institute that
50:21just a few months ago
50:22published their survey that they
50:23just did on their own.
50:25Also,
50:26nationally representative, not including twelve
50:28and up. This was all
50:29adults in the United States,
50:31and they asked about past
50:32year psilocybin
50:33mushroom use. And their estimate
50:35is actually it's like between
50:37it's about, like, three percent
50:38of the population.
50:39So we're starting to get
50:40this data that we can
50:41start to think about the
50:42denominator
50:43of people using recently.
50:45And so we can wrap
50:46up. I wanna just skip
50:48ahead and say we're also
50:49looking at toxicology data specifically
50:51from the National Poison Data
50:52System that looks at at
50:54toxicology calls. These are people
50:56from ambulances or home or
50:57even emergency departments who call
50:59to report things, and they
51:00have a specific code for
51:02mushrooms, LSD, etcetera.
51:05And,
51:05so we started doing this
51:07work just looking at not
51:08just the denominator of use,
51:09but also are there SAEs
51:11or, you know, ED engagement
51:13nine one one calls that
51:15we can start to track.
51:17The lines at the very
51:19top
51:20are,
51:22other toxic plants and nonpsychedelic
51:25mushrooms. So just to put
51:27it in perspective, the number
51:28of toxicology calls, poison control
51:30calls for nonpsychedelics
51:31is is higher,
51:34over time. And yet if
51:35we zoom in, specifically looking
51:37at psilocybin related poison control
51:39calls, we can see across
51:40different age ranges that does
51:42seem to be increasing.
51:44And this is not just
51:45our data, but this is,
51:47I'm sorry. One sec. When
51:49we go back and look
51:50at over ten years, there's
51:51very few deaths, but there
51:52are some people with major
51:54effects. So people with ongoing,
51:56you know, impairment or serious
51:57health risk
51:59are showing up at a
52:00small percent of of
52:02of psilocybin related calls,
52:04and sometimes they are getting
52:05admitted to institutions.
52:07This agrees with other data
52:09that have come out just
52:10within the last year, looking
52:11at EDs in,
52:13in California and another group
52:15that's looking at poison control
52:17falls nationally.
52:20I should end so we
52:21can so we can talk.
52:23But I'm I just wanna
52:24put one sort of thing
52:25out there, which is that,
52:26the last data we're collecting,
52:28this is, like, our most
52:29expensive and hard to do,
52:30but we're actually getting EHR
52:31data from three different health
52:33care centers in Oregon, and
52:34we're
52:35merging it together to try
52:37to get actually a close
52:37look at who are the
52:38people coming into the EDs.
52:40Actually getting
52:42semi identified data from other
52:43health systems so that we
52:44can combine them has been
52:46very laborious, and, it's gonna
52:48it's the subawards and everything.
52:50It's like a ton of
52:50work to manage, but I'm
52:52looking forward to having this
52:53someday so we can actually
52:54see
52:55demographic, medical history profiles, what
52:57actually puts people at risk
52:59potentially for having ED visits
53:01related to psychedelics.
53:03And,
53:04we really should I'm not
53:05gonna get into the details,
53:07but I just wanna wrap
53:08up and say
53:10it's just sort of big
53:11picture.
53:12Some people might say this
53:12is kind of like an
53:13early version of phase four
53:15data. We can see what
53:16what happens in more sort
53:17of community use before the
53:18FDA even approves anything. But
53:21another way to think about
53:22it is we're just catching
53:23up with what the communities
53:24have been doing and their
53:25own sort of expertise and
53:27innovation is something we can
53:28we can study.
53:30I find the mixed method
53:31approach very helpful in sort
53:32of coming up with initial
53:34descriptions of safety practices, but
53:35also really sort of serious
53:37adverse events that if we
53:39build partnerships with communities, they
53:40might talk to us about.
53:41These would be things we
53:42might wanna know before we're
53:43dosing people in medical settings.
53:46But in the community engagement
53:48and the collaboration part is
53:49what is making all of
53:49this work. Unfortunately, we've had
53:51some delays,
53:52but we're still working on
53:54this contract. And I'm looking
53:55forward to having not just
53:56pilot data and the sort
53:57of initial epi data that
53:59we can talk about later.
54:01And I'll stop.
54:10Questions?
54:13Both,
54:14in the room or online.
54:22Just gonna say more of
54:23the statement if you're ever
54:24interested in talking to the
54:25foster care community
54:26about their use. They're wide
54:28open. Very happy to talk
54:30about what they've been doing
54:31for the past thirty years.
54:33So,
54:34we have to offer this
54:35project, but
54:36we're we're.
54:39So I don't know if
54:40folks on Zoom can hear
54:41that, but doctor Schindler was
54:42recommending cluster busters or a
54:44rich source of patient reported
54:46outcomes from their own use.
54:49Both, efficacy
54:50and also safety.
54:54We are talk talking about
54:55that. Yeah.
54:57Yep.
54:59Try to think about the
55:00validity
55:01of data collected
55:03through the changes because there
55:05is some community protective that
55:07they might will not be
55:09willing to disclose really adverse
55:10event. But they're self protective
55:13of the ceremony.
55:15And why
55:16should I discourage
55:18people that will
55:19be
55:20I'm really tremendous to to
55:23person that Yeah. Starting to
55:26Totally.
55:28So
55:29when we sit down with
55:30people in an interview, sometimes
55:32we do these over Zoom
55:33or in person,
55:34I feel like they don't
55:35bring up things that when
55:37we're having lunch with them
55:38later during the site visit,
55:39they start talking about it.
55:40And that's for me is
55:41the power of the ethnographic
55:42method is you just build
55:43relationships and people engage with
55:45you differently as an investigator.
55:47People also talk to us
55:49way differently
55:50after I would go and
55:52be in a ceremony with
55:53them. They would open up
55:55and engage and even be
55:56open to interviews. So part
55:57of it is building the
55:58relationship.
55:59And, interestingly, going back to
56:01the comment of a number
56:02of them are concerned about
56:03what we're doing in medical
56:04spaces,
56:05that's actually incentivizing
56:06some of them to actually
56:08talk. They feel like there's
56:09more acceptance. There's less stigma.
56:11They have expertise. They wanna
56:12share with people about safety,
56:13and they're concerned that we're
56:14gonna hurt people. So they
56:16wanna teach us about how
56:17not to hurt people. And
56:18they state that as a
56:20motivation for even sharing some
56:21things that they have seen.
56:23It's not absolute, but I
56:25find it as an interesting
56:26sort of dialogue we can
56:27we can have with them.
56:29For the people online who
56:30didn't hear the question,
56:31it was about the reliability
56:33of self reported
56:34adverse events in these other
56:36settings,
56:38where there might be an
56:39incentive to,
56:42not disclose,
56:43some
56:45experiences.
56:46Yeah.
56:48But, again, I'm just following
56:49up on it. I mean,
56:51even with what they're telling
56:52me, what's
56:54the credibility of this? Mhmm.
56:57They're it seems like they're
56:58highly motivated to keep doing
57:00this. Mhmm.
57:02They don't want
57:04negative perceptions. I mean, I've
57:05seen this with all types
57:07of work. It's not just
57:08this.
57:09If there's nobody really checking
57:11it, like a clinical trial,
57:12you know, it doesn't matter
57:13what somebody's looking over your
57:15shoulder.
57:18How do how credible do
57:19you the movie that actually
57:20is? I mean, you said
57:21it sometimes, so say one
57:23thing at a time or
57:23another. But, you know, I
57:24mean, it is the nice
57:25part of doing it in
57:27the field because you're getting
57:28the real sense.
57:29How
57:30to, you know, to follow-up
57:32says how credible you think
57:33it is. And the people
57:34that haven't had a good
57:35result,
57:36how willing are they
57:38to talk and how
57:39what access do you have
57:40to them? Yeah.
57:42So,
57:44we
57:45what's helpful is that a
57:46few of our community advisory
57:49board members who serve as
57:50the liaisons with the communities,
57:51a couple of them have
57:53health care licensure.
57:55So they are in both
57:56worlds, and it's been helpful
57:57to talk to them about
57:58how this information is important.
58:00And they understand that, and
58:01they want us to hear
58:03about things that that happen.
58:05So we have to find
58:06the right partners to do
58:07the work in the first
58:08place.
58:10Another part of it is
58:11that
58:12there's obviously gonna be things
58:13that they're just not gonna
58:14tell us. And so we
58:15won't be able to conclude
58:16anything, again, absolute about what
58:18is or is not happening.
58:21I really see this work
58:22as as an initial
58:24step in what could become
58:26a collaborative form
58:28of surveillance that if if
58:30this does open up more,
58:32we will learn things.
58:33One of our respondents who
58:35told us about a
58:36traumatic brain injury that they
58:38experienced
58:40during and right after a
58:42ceremony that they thought was
58:43actually very much related. Like,
58:44I I believe them,
58:46and not everyone will probably
58:48talk to us about about
58:49that. But when the when
58:51that does come up and
58:52we can use this as
58:53an exercise
58:54to demonstrate to these communities
58:56that we can take them
58:57seriously, I think dialogue like
58:58that will be better in
58:59the future.
59:00So I think there's, like,
59:00a there's a functional reason
59:02to engage in this way.
59:02And we also know that
59:03in some clinical trials, some
59:03things don't get reported either.
59:03And
59:06so we also know that
59:06in some clinical trials, some
59:08things don't get reported either.
59:09And so it's not That's
59:11because of the cult culture
59:12that is different around
59:14that. Well, there's there's there's
59:16lots of incentives,
59:18but when there's there's no
59:19one checking
59:20when there's no one checking
59:22and and there's no state
59:24authority that gives you permission
59:26to be a church,
59:27the only churches that have
59:28those registrations
59:29sued the government,
59:30and then we're allowed to
59:32get it. But there's not
59:33like there's a lot of
59:34these out there, and and
59:35we're really just trying to
59:36build a bridge to have
59:37that communication to start with.
59:41We had a slide where,
59:43where the term harm reduction
59:44didn't quite ring with the
59:46churches because for them, this
59:47is part of the experience.
59:49What are your thoughts about
59:51the fact that adverse that
59:52you have to report things
59:53like, you know, things that
59:55are normal when you have
59:56a psychedelic experience, like, you
59:58know, even mild anxiety. Well,
60:00obviously, that
01:00:01is a adverse event, but
01:00:02even things like changes in
01:00:03your in your perception, like
01:00:05the colors melting or whatever.
01:00:07Mhmm.
01:00:08That's kind of a different
01:00:09topic. But some of us
01:00:11would would would consider that
01:00:12adverse event. Some say that's
01:00:13just what happens when you
01:00:14take a psychedelic, and that
01:00:16could even go all the
01:00:17way up to kind of
01:00:18a challenging experience if that's
01:00:20if that's therapeutic.
01:00:21So the definition of adverse
01:00:23event can like, where someone
01:00:25draws the line can be
01:00:26quite different. So the churches
01:00:27might have the the line
01:00:28way over here, whereas, like,
01:00:29the FDA has the line
01:00:31way back here. I guess,
01:00:33what are your thoughts on
01:00:34that
01:00:35general? I mean, we had
01:00:36a this is one of
01:00:37the reasons I like working
01:00:38with the community advisory board.
01:00:40We specifically talked about terminology
01:00:42to use in the interviews
01:00:43with people about, yeah,
01:00:45a,
01:00:46unexpected,
01:00:48serious, like, how can we,
01:00:49like, elicit people to talk
01:00:51about these things? I mean,
01:00:52we come down to
01:00:53just descriptions of, like, does
01:00:55it does it make you
01:00:56not be able to do
01:00:57go to work and, like,
01:00:58do things with your family
01:00:59or attend church? And, like,
01:01:01people get that. You know?
01:01:03Or were you hospitalized? Like,
01:01:04it's, like, a very concrete
01:01:05thing regardless of whether or
01:01:07not you said it was
01:01:08good for you. Again, one
01:01:09of our respondents who reported
01:01:11having this
01:01:12neurologic injury,
01:01:13related to being in ceremony
01:01:15also said it was one
01:01:17of the best things that
01:01:18happened for me because after
01:01:19that, I changed my career.
01:01:21My life was less stressful,
01:01:23and I'm in a much
01:01:24better place.
01:01:25Okay. But they also, you
01:01:26know, had went through a
01:01:27serious medical condition, could have
01:01:29died. They're aware of that.
01:01:31But we're
01:01:33I also hear that as
01:01:34if we're gonna talk to
01:01:35people and we wanna engage
01:01:36on public health or interventions
01:01:38to reduce risk, we have
01:01:39to understand their perspective they're
01:01:40coming from. And if we
01:01:42just go in and say
01:01:42we need to reduce the
01:01:43harm of your practice, they're
01:01:44not gonna talk with us.
01:01:45So it's part of it's
01:01:46building that communication about how
01:01:48to even discuss these things.
01:01:53Yeah.
01:01:57Just how how can we
01:01:59approach tracking this and finding
01:02:01out the adverse event profiles,
01:02:02but really
01:02:03coming to understand what we
01:02:05can take from these groups
01:02:07that have built and cultivated
01:02:08their own knowledge. And, you
01:02:10know, while they're maybe not
01:02:11using the perfect scientific method,
01:02:12they can look at cause
01:02:13and effect. If what they
01:02:14were doing was causing all
01:02:15of their members to keel
01:02:16over,
01:02:17they wouldn't be doing it.
01:02:19Yeah. No. I'm especially that's
01:02:21the advice
01:02:22that mentioned of, like, if
01:02:23someone's having a terrible time,
01:02:24give them more. Yeah. And
01:02:26that
01:02:27being really counterintuitive,
01:02:29but at the same time,
01:02:30it would suggest that it's
01:02:32based on them having done
01:02:33trial and error within their
01:02:35community and finding that it
01:02:36was beneficial at least in
01:02:37some cases
01:02:38and what we can learn
01:02:40from that.
01:02:42I I don't think in
01:02:43my next trial at UCSF
01:02:45when someone's having a really
01:02:46hard time, they'll allow me
01:02:48to give a little bit
01:02:49more. No. But
01:02:50That idea that that
01:02:52But I
01:02:54what they've
01:02:55observed.
01:02:57No. I mean, absolutely. And
01:02:58I think, again, opening up
01:02:59that dialogue to just hearing
01:03:01about some of these I
01:03:02mean, the the pregnancy example,
01:03:03I think, is is very
01:03:04real. None of us have
01:03:05any data on on the
01:03:06effect of psychedelics during from
01:03:08during pregnancy from clinical trials.
01:03:10There's one case report published
01:03:12from a study that Tim
01:03:13Leary did in the sixties,
01:03:14and they said the baby
01:03:15was born fine.
01:03:17Okay. So That's insane. I'm
01:03:18not gonna So particularly
01:03:21But but there's there's there's
01:03:22practices. There's actually generations of
01:03:24people. I know people who
01:03:25say that they started drinking
01:03:26Ayahuasca when they're in their
01:03:27mother's womb, and they still
01:03:29drink it, like, decades later,
01:03:30and and these are the
01:03:31stories. Now does that mean
01:03:32that nothing would have been
01:03:34different had that not happened?
01:03:35No. Of course not. But,
01:03:37I mean, some things I
01:03:38take away from this is,
01:03:39again, we have
01:03:41people who are the guardians,
01:03:43who are the caregivers, the
01:03:45facilitator, the session monitor in
01:03:47a trial setting,
01:03:48taking the sacrament,
01:03:50saying that they get to
01:03:51the point where they're having
01:03:52a challenging experience, but they
01:03:54do a form of maybe
01:03:55a meditation or a prayer
01:03:56that allows them to radically
01:03:58alter the the subjective experience
01:04:00they're having. I would love
01:04:02to know how to, in
01:04:03a brief way, teach my
01:04:05participants
01:04:06to do something like that
01:04:07if I think that could
01:04:08help them feel
01:04:09safer and have a less
01:04:10challenging experience
01:04:12if that were sort of
01:04:13you know, what would be
01:04:14the thing the right thing
01:04:15for my participant?
01:04:16How do we teach that?
01:04:17Is that a cultural thing?
01:04:18Do you need exposure to
01:04:19the community for two years
01:04:21to do that, or can
01:04:22we teach it in a
01:04:23brief thirty minute session before
01:04:24we dose?
01:04:26I would we should we
01:04:27should try to figure that
01:04:28out.
01:04:36So doctor Schindler said it's
01:04:38almost like lucid dreaming where
01:04:39you can kinda take control
01:04:40of the experience. I I
01:04:41very much agree. I tell
01:04:43my trial participants this is
01:04:44like dreaming while awake.
01:04:47And
01:04:48I am always fascinated by
01:04:50the stories I hear from
01:04:51people who are long time
01:04:52practitioners in those communities about
01:04:54how they talk about how
01:04:55they can control it. They
01:04:57can get up. They can
01:04:58play guitar. They can then
01:04:59finish their song, lay down,
01:05:01and have a full on
01:05:02experience again, and they learn
01:05:04to modulate it.
01:05:05And these are sort of
01:05:06qualitative reports that I think
01:05:08are help me question this
01:05:10idea. We have a psychedelic
01:05:11experience. You just lose all
01:05:13time and space, and you
01:05:14come back and you're better.
01:05:15But maybe there's an active
01:05:16embodied component that's happening for
01:05:19our patients so we can
01:05:20make it more helpful.
01:05:23I would like to learn
01:05:24more about that.
01:05:27I wanna be mindful of
01:05:28people's time,
01:05:30but also wanna take advantage
01:05:32of the
01:05:34discussion that we're having.
01:05:39Did you have any,
01:05:40IRB
01:05:41trouble in terms of getting
01:05:42approval on the IRB side?
01:05:45The hardest thing was getting
01:05:46the IRB approved
01:05:48in Brazil because we went
01:05:49through that process, and I
01:05:51had to register with the
01:05:52national IRB. And then we
01:05:53had to get traditional knowledge
01:05:55exemption because we were studying
01:05:56a traditional
01:05:57form of
01:05:59not plant use in Brazil,
01:06:01and that was way harder
01:06:02than any IRB thing we
01:06:03did here. Survey from the
01:06:04start of shipping. Well, in
01:06:06in in Brazil, it's just
01:06:08a survey. Yeah. But because
01:06:10we had federal funds going
01:06:11there, they had to be
01:06:12on our IRB, and we
01:06:13had to be on theirs.
01:06:14Mhmm. And I'm glad we
01:06:15did it. I'm glad we
01:06:17got the sub to Brazil
01:06:18for a year, and they
01:06:19got going. It was totally
01:06:20worth it, but it was
01:06:21super challenging.
01:06:23Yeah.
01:06:27For me, it for me,
01:06:28it's interesting with them.