Discover U Podcast with JD Kalmenson

Willa Hall, PhD: MDMA, A New Frontier in Treating PTSD

June 27, 2022 JD Kalmenson, CEO Montare Behavioral Health Season 2 Episode 12
Discover U Podcast with JD Kalmenson
Willa Hall, PhD: MDMA, A New Frontier in Treating PTSD
Show Notes Transcript

Montare Media presents Season 2, episode 12 of the Discover U Podcast: MDMA, A New Frontier in Treating PTSD, with Willa Hall, PhD

Learn More about Montare Behavioral Health:

JD Kalmenson interviews Willa Hall, PhD, who is a facilitator and trainer in the MAPS phase 3 clinical trials being done with MDMA to treat severe PTSD. Learn about the exciting new breakthroughs possible with the assistance of MDMA, and how each session is conducted. 

Over the past 20 years, Dr. Hall has dedicated herself to working in community mental health and private practice in New York City. She has a particular interest in understanding the ways in which the therapeutic relationship and, in particular, the therapist’s authenticity facilitates a client’s deepening appreciation of their own authentic self. In 2017 she began work on the MAPS (Multidisciplinary Association for Psychedelic Studies) NYC site as a co-therapist on the Phase III trials assessing the efficacy of MDMA-assisted psychotherapy for severe PTSD. More recently, Dr. Hall’s attention has turned to understanding the therapist’s role in treatments that utilize non-ordinary states of consciousness in order to maximize growth and healing.  She is a Clinical Adjunct at the New School in NYC, a MAPS-trained certified supervisor of MDMA-assisted psychotherapy, and founding member and President of Nautilus Sanctuary, a non-profit in New York City dedicated to increasing accessibility of psychedelic treatments to disadvantaged populations. One of Nautilus’s first projects is a research study that will offer MDMA-assisted therapy to healthcare and hospital workers having difficulty recovering from their experiences on the frontlines of the Covid Pandemic. The study protocol will be submitted for FDA approval this Spring, 2022, with plans to begin recruitment later this year.

Host Kalmenson is the CEO/Founder of Renewal Health Group, a family of addiction treatment centers, and Montare Behavioral Health, a comprehensive brand of mental health treatment facilities in Southern California. Kalmenson is a Yale Chabad Scholar, a skilled facilitator, teacher, counselor, and speaker, who has provided chaplain services to prisons, local groups and remote villages throughout the world. His diverse experience as a rabbi, chaplain, and CEO has inspired his passion and deep understanding of the necessity for effective mental health treatment and long-term sobriety.

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JD Kalmenson:

Welcome to another episode of Discover U, our podcast exploring innovative and effective solutions to issues in mental and behavioral health. I'm JD Kalmenson, CEO of Montare Behavioral Health, a family of dynamic and comprehensive mental health treatment centers in Southern California. I'm so honored and excited to introduce you to our pioneering guest today Willa Hall PhD. 

Over the past 20 years, Dr. Hall has dedicated herself to working in community mental health, and private practice in New York city. She has a particular interest in understanding the ways in which the therapeutic relationship and in particular, the therapists authenticity, facilitates a client's deepening appreciation of their own authentic self. In 2017 she began work on the MAPS, multidisciplinary association for psychedelic studies, New York City site, as a co-therapist on the phase three trials assessing the efficacy of MDMA assisted psychotherapy for severe PTSD. More recently, Dr. Hall's attention has turned to understanding the therapist's role in treatments that utilized non-ordinary states of consciousness in order to maximize growth in healing. She's a clinical adjunct at The New School of New York, a MAPS trained certified supervisor of MDMA assisted psychotherapy and president and founding member of Nautilus, a sanctuary, a nonprofit in New York city dedicated to increasing accessibility of psychedelic treatments to disadvantaged populations. 

Welcome Willa. I am truly honored and grateful that you've taken the time to be with us today. And share your knowledge on a topic that is really cutting edge of new therapeutic interventions. 

Willa Hall: Great. Well, thank you so much for having me I'll do my best. I'll do my best. There's a lot of nuance in this work, so we're excited to have the opportunity to talk about it. 

JD Kalmenson: Amazing. And you know, psychedelics is such a hot topic, not just in behavioral health right now, but nationally, and I'm looking forward to hearing about your experiences using these substances for therapeutic treatment, but before we even jump in, can you share with us a little bit how you became interested in working with psychedelics?  

Willa Hall: I think, you know, it probably just starts with an intuitive kind of appreciation for what psychedelics can do. I mean, I like many people spent some of my college time experimenting with psychedelics and had some really, you know, really important experiences. And so when I heard, , I think it was back in 2015, maybe then doc, , Michael Pollan wrote that article in the New Yorker called the trip therapy where he was talking about the research being done at NYU and, and John Hopkins using psylocibin  assisted therapy to treat, end of life anxiety. I just gobbled up that article and it just made so much sense to me that these medicines could be really helpful for people dealing with these very, very difficult issues. So, I was in private practice at the time and I just, you know, started to sort of make inquiries and, and sort of followed my nose and the timing was excellent, and I was able to sort of get into the tail end of MAPS' recruitment for their phase three therapists. So I found myself at a retreat, the first retreat to train phase three therapists.  I guess it was the, the fall of 2016. 

JD Kalmenson: When you reference phase three, for the layman, and out of ignorance, are there going to be more phases? Is that the final phase? 

Willa Hall: No. Phase three is the final phase. It's a final set of studies that need, to be completed before we can submit that data to the FDA for their approval of, you know, to legalize MDMA assisted therapy. 

JD Kalmenson: So the legalization of MDA and FDA approval go hand in hand one cannot happen without the other. 

Willa Hall: That's right. That's absolutely right. Yes. 

JD Kalmenson: Gotcha. And I realize that you specialize in working with MDMA, but would you be able to give us a brief overview of some of the most prominent forms of psychedelic therapy? And do we yet, do we know, do we yet know if some of them are more helpful for certain conditions? 

Willa Hall:  I could tell you that the most prominent forms, especially, that I know of, and I think that are practiced in the US right now, are psylocibin assisted therapy that I mentioned before, and also ketamine assisted therapy. Those are two very different drugs, but they both sort of afford a certain altered state of consciousness that can be very useful, to leverage and for therapeutic purposes. Psylocibin assisted therapy, like I said, was very effective with end-of-life anxiety. It's also being used to treat treatment resistant depression, smoking cessation, other kinds of forms of addiction, cocaine addiction, for instance. And there's a lot of promise in psylocibin assisted therapy. It's a very different kind of therapy than MDMA assisted therapy, but, you know, we're very excited about sort of what we're finding from the trials. The other form of, therapy that a lot of people or psychedelic therapy that people are talking about is ketamine assisted therapy.

JD Kalmenson:  And that's legal. 

Willa Hall: That is legal because ketamine, is a legal substance and it can be used off-label to treat what's most prominently treating, depression, but also people feel that it can be helpful for, for other things like anxiety, PTSD, all sorts of all sorts of forms of distress. 

JD Kalmenson:  The legalization of ketamine versus psylocibin, just because the research went in earlier, the trials happened earlier, is just more advanced, or is there something fundamentally different about ketamine that, you know, made it an easier process for the legalization?  

Willa Hall: Well, I think the fact is that ketamine was never a schedule, one drug. It was always seen as having medicinal value. And so what I think what happened, and I'm, you know, you'd really have to ask a psychiatrist about this more, but what would happen is that it would often be given to sort of relax patients in the emergency room and then, agitated patients. And then they would sort of find out that there was also these associated, effects of sort of a relief of anxiety or depression that would happen when they would come to. And the experience of the ketamine seemed to be helpful in other ways. And so I think that piqued the curiosity of, of some people. And I think there have been extensive trials in terms of studying ketamine assisted therapy for depression. Ketamine has the… it's kind of an interesting drug because it has this immediate antidepressant effect. Yes. So that's why you have the, you know, ketamine infusion clinics, and, and you can take somebody who has sort of an intractable depression or suicidal depression, and you can, give them an infusion and over a series of infusions that depression lifts, which is quite remarkable and, and lifesaving for many people. Cu

JD Kalmenson: Yes, yes. We actually provide it through Spravato, the intranasal… and it does help a lot. We shy away from utilizing it for, for folks who are struggling with chemical dependency specifically.  

Willa Hall: Think that's right. 

JD Kalmenson: That's a biggie, but also we found, like you said, it, it, it's a, it's an incredible infusion to help dramatically decrease some of the intense acute symptoms of depression, but, you know, following it up with a lot of the traditional organic talk therapy or other modalities really helps sort of sustain and build on that momentum. 

Willa Hall: Exactly, that's such an important point. That's such an important point. Yeah. 

JD Kalmenson: That's amazing. So, so you were saying psilocybin assisted therapy, ketamine assisted therapy, and then is, were there any others ayahuasca I know is a really hot topic?  

Willa Hall: Ayahuasca is a hot topic, but I, I mean, that is not, that has not to my knowledge, been through any kind of systematic study and I know Ibogaine too, is, has, you know, captured a lot of attention as a treatment for drug abuse, but, that's not my area of expertise.

JD Kalmenson: It's interesting. It sounds almost like because the psychedelics, have so many sort of specific offshoots with rare, unique, properties, that legalization of one doesn't necessarily, you know, make it all, legal and make it all, put it all in the same sort of bucket. 

Yeah. I mean, I, so let's, let's talk about MDMA, tell us a little bit, I mean, that's the phase three trial that you're, that you're very much involved and associated with. What's the history of MDMA?  

Willa Hall: It is a very unique chemical that was first synthesized, by, I think Merck pharmaceuticals in the 1920s. And then when it didn't show any sort of, you know evidence of effect on animals, it was just sort of put away and lost to obscurity in the 1970’s. 

JD Kalmenson: Synthesized. I'm sorry to interrupt. You mean that it comes from other plants or other? 

Willa Hall: No, MDMA is a chemical. It does not come from plants, and that's a distinguishing factor of it too. It's made in the laboratory. So, it was lost to obscurity until the 1970s, when the chemist, Alexander Shulgin, rediscovered it, re synthesized it, and tried it out himself as he was want to do and found that it afforded a certain kind of mindset that he thought might be very helpful in therapy. There's sort of a relaxing of the mind and openness and open-heartedness, and he gave it to his therapist, friends, and it became something particularly in the bay area and therapeutic circles that was used quite widely for therapy purposes.

JD Kalmenson: During therapy, 

Willa Hall: During therapy. Yeah. 

JD Kalmenson: Not as an intervention in and of itself.

Willa Hall: Right. It's during therapy, it's just sort of enhanced that therapeutic process. And very useful in particularly with couple's work where there's sort of a certain defensiveness, you know, between two people that, that the MDMA helps to ameliorate 

JD Kalmenson: Lower their guard. Yeah. 

Willa Hall: Right. So that's when it kind of came back on the scene, and I think a lot of therapists found that it was very useful for their work, but then it seemed to escape into the party scene. It became what we know now as Ecstasy or Molly and sold underground. And that's when the DEA came in and, you know, rescheduled it, to a schedule one substance, a drug without medicinal value, and so that happened about 35 years ago, I think, in 86. And in reaction to that, that's, I, I believe that's MAPS' origin story is. The founder of MAPS felt that this was a grave injustice that his own experience on MDMA had been profoundly helpful and he saw the value of a drug like that to help people heal. And so he founded MAPS, as a way of rehabilitating MDMA and probably other psychedelic substances, to sort of a status of, having some value in helping people. 

JD Kalmenson: That's amazing. I love those, those words, rehabilitating MDMA. 

Willa Hall: It is what we're doing. It is absolutely what we're doing. 

JD Kalmenson: That's right. And, my understanding is that you're, you're focusing a lot on treating PTSD specifically. 

Willa Hall: Yeah. Yeah. 

JD Kalmenson: Why, why PTSD? Is there a unique, dimension to that type of trauma that lends itself to a higher efficacy with MDMA? 

Willa Hall: I would say yes. I would say yes, especially. I mean, absolutely. You know, it's almost like an ideal fit if you will. What MDMA can do pharmaceutically is that it quiets the fear response. It quiets the amygdala. It enhances activity in the prefrontal cortex, the cognitive and conscious processing and, and enhances activity in the hippocampus, so memory. So when you've got that quieting of fear, and you've got this enhanced ability to sort of process material, it makes that kind of that mindset, you know, that brain process is ideal for sort of dealing with trauma, because the, you know, the deal with PTSD is this, you know, you have a traumatic event, right. , and when a traumatic event is experienced, there's a sense of horror and helplessness that is overwhelming to the brain. so that it, the brain can't consciously process, the experience in any way. And so, the trauma gets sort of lodged in the nervous system, where it can be then triggered by associated stimuli, like, you know, sights or smells or sounds. And then people are just sort of left feeling like, you know, walking around with a sense of sort of being broken, right. They've had this experience that they cannot make sense of, and their nervous systems are wired to respond to, you know, anything that is associated with that, with the experience that they've had. So they can't really continue on and have a normal life. And it's very, very, as you can imagine, distressing, and it, it, I mean, the statistics on PTSD are stark and, and frightening for people. There's high rates of suicide. And, it's just a miserable existence. So what's so nice about MDM a right, is that it, it allows you this mindset, it allows you, this, this, this experience, , of relaxing, your fear response, so that you are able to move towards that traumatic experience and spend time with that experience sort of putting together this story of what happened and putting together the memory of what happened, the sounds, the smells, I mean, it's really quite extraordinary sometimes when people are on it, what they remember, it's so specific, and they've never been able to go so deeply back into the experience before it's really, quite a remarkable… 

JD Kalmenson: That’s amazing. So, the MDMA is creating the right conditions for somebody to feel safe, to re-engage with that memory and the re-engaging with the memory and being mindful and present in that very frightful situation, but not having that fear, is actually what brings about the healing is the therapeutic experience. 

Willa Hall: That's exactly right. That's exactly right. Because what we, we know about healing from trauma is that when we can put something into a, a coherent narrative, it is a way that we sort of manage our feelings about it and understand what happened and understand our part in it and other people's part in it. And, so, yeah, it, it's exactly right that we have this, we have this opportunity for someone, has this opportunity to really kind of take a dive into that experience and work out that narrative for themselves. And work out those associated feelings of guilt and shame and disgust, and really kind of resolve a lot of the problematic narratives that come out of, you know, having had an experience like that.  And so what I really noticed I'm sorry, is that people really have a better relationship with themselves after the treatment.

JD Kalmenson: Yes. And based on what you're describing the therapy team, and especially what we were talking about earlier, your belief that the temperament, the authenticity, the spirit, the disposition of the therapist plays such a dramatic role in the efficacy and in how impactful the treatment will be. It makes so much sense because the MDMA is really just creating the right conditions. But ultimately it's what you do when you're in that state. 

Willa Hall: Right. Right. It's the therapy relationship. That's the container that's right. For that processing. Yes, absolutely. Yeah. 

JD Kalmenson: That's amazing. So some technical questions about the parameters of the study, how is it administered? How many sessions, are they spaced apart? You know, what does that look like? 

Willa Hall: Well, I'll tell you what the, the protocol is for the treatment that we are studying. And then I think once FDA approval comes around there, there's going to be some room through wiggle room to sort of adjust it. But basically we, you know, there's a screening process. And once, once somebody has made it through that process, they're assigned to a therapy team, and the therapy team begins to meet with the participant, for what we call preparatory sessions, prep sessions. These are 90 minutes long. We have three of them and it's an opportunity for the therapy team to get to know the participant and the participant to get to know, us, to develop that rapport, develop that sort of trust and open communication as much as possible. We don't it's most, you know, we don't, we're not really even instructed to talk about the, the trauma, it's really more about, creating that good rapport and also doing some psycho ed around what they can expect, when they take the medicine, you know, like what, just sort of, how the day is going to go, what they might expect to feel like when they’ve taken the medicine, just anything that's going on. All the information that they're going to need to feel as relaxed and as open to the experience as possible. So that happens again in three 90-minute prep sessions across, you know, a couple of weeks, and that prepares everybody for the dosing day. And that day people come in early in the morning, 

JD Kalmenson: Those I'm sorry to interrupt. So those 90-minute sessions are done without any type 

Willa Hall: Of, no, it's not they're non-drug sessions. 

JD Kalmenson: Yeah. Non-drug sessions and the conversations are rapport. They're not necessarily, you know, deep dives into, you know, experiences and, you know, sort of what you would find in a typical talk therapy session. They're just, you know, rapport building 

Willa Hall: They're rapport, building psycho-ed. I mean, you know, I think as a therapist, you want to get that kind of information, but we don't press people to say anything that they don't feel ready to say. So those non-drug sessions move us to the dosing day. People come in early, dressed in comfortable clothes. They they're going to actually spend the night at our site, so they bring an overnight bag.I think, what we’re trying to do is just kind of trying to create a safe place for this person to sort of enter into this new experience. So, but we do sort of talk about, you know, where they are, what they want to happen, what, you know, what, what their intentions are to work on. If they have any, and we offer them the medicine. We never give it to them. We offer it to them, they take it, and then they usually feel the effects, between, usually half an hour to an hour into, into the session. They'll start to feel the effects of the medicine, by an hour, hour, and a half into it. They're definitely in the experience and you never know, you never know what what's, what that, what that is going to be for them. 

Willa Hall: It's not a guaranteed, oh, I feel great. This feels wonderful. That can happen, but it can also be very intense for them. You know, this might be the first time in their lives that they have to, that this, sense of anxiety has been sort of disabled and they can feel that can feel very jarring too. You know, like this doesn't feel right. You know, so you just never know, some people can actually get quite anxious initially when they're coming onto the medicine. So I kind of liken it to sort of landing on the moon or Mars. You just don't know. And as a therapist, you're just ready to try to receive and support whatever's happening. We are there in the service of the participants' process, whatever that, whatever happens, whatever the medicine catalyzes, we're there to support it. We're there to offer reassurance. We're there to sort of you know, kind of, support anything that might feel difficult. A lot of times, I mean, what we learn to do is really try to help somebody stay with something that might feel hard.

JD Kalmenson: Would it be very dissimilar to alcohol or to other substances? Like I know, you know, with, with meth, there's like a, you know, people who've used it report this tremendous unleashing of creativity and that's part of what makes it so alluring for them. But ultimately, you know, for somebody who hasn't is not in that space, who hasn't been using meth or been drinking with them, they don't really find a lot of their words or messaging to be super coherent and cohesive. So this is, this would be very different than that. 

Willa Hall: It is a very different experience, I think in part, not just because I think that it's a different medicine, but also the intention in taking it is very different. There's very much the intention of sort of you, you know, this is about you going in, to sort of make a connection to yourself. Whereas I think, well, alcohol, I tend to think of something sort of numbing anyway, it's a sort of a numbing of feelings. So in that way, I see it as very different than, MDMA. There's a meth aspect to MDMA, it has a methamphetamine in it. So there is a lot of cognitive processing. There's a lot of talking, that people often want to do. But it's then sort of mitigated also then by this sort of quieted fear response that allows, and because of the intention is to sort of process something that has been troubling them often for years, there's this way in which, the focus is internal and, about kind of allowing what has never been allowed to come to the surface, come to the surface. 

JD Kalmenson: I love the words that you're saying about the intention. It's so powerful because it's not only about an MDMA phase three trial. I mean, there's so many experiences in life that when you have the right intention going in, it will literally create a certain outcome. It will steer you away from an undesirable one. So I just wanted to pause for a second and, and, and unpack that one line for the audience, how that that's, that's, that's an amazing, sentiment in and of itself, but carry on, please. 

Willa Hall: Yeah, no, that's thank you. I appreciate that. I think that's absolutely true. So, so it's a long day. It's about six and six to eight hours. We get, we do give a booster, dose, which is half the original dose, that we give in the beginning just to extend that window of tolerance in which people are able to sort of, you know, continue working on difficult material and having things come up. So it's about a six-to-eight-hour day, and the therapists again are just there sort, sort of supporting, and, we're encouraged to, to remain present and open the entire time. We're not like reading a book or tuning out at any moment. 

JD Kalmenson: And that’s very intense for a therapist. You're talking about an eight-hour session, or something close to it. That's why, and, and you're, and you, you don't have any MDMA so it's...

Willa Hall: Yeah, but you kind of, you kind of do, you know, you kind of have some, I it's just in the air, that's what it feels like, you know, it's, you cannot not feel the energy of what's coming at you, when somebody's got that medicine and it's so it's fabulous. I really, it's just such an extraordinary experience. But I'm certainly glad that there's another therapist there, because a lot of very painful things come up, that can be very hard to hear and to hold. 

JD Kalmenson: When you say another, are you talking about two therapists per client, or you …

Willa Hall: There's two therapists per client.  

JD Kalmenson: Two therapists per client. Got it.

Willa Hall: Yes. So I work, yeah, I work as a co-therapist on a team with somebody else, and I'm just always so grateful for their present presence, because it's not just about the fact that it's a long session, but it's also about the fact that we are digging into very difficult material, that there are some really severe stories and horrors that we, that we are hearing about and need to stay present for. And, you know, right afterwards, as we're leaving the site, we usually just look at each other and say, how are you? You were doing okay. You know, wow. When this happened, when, when they said this, I felt this, you know, we just, we need to, you know, you're holding so much. 

JD Kalmenson: Right, and you're receiving so much yes. In that, in a six-to-eight-hour session like that. So, you know, you help each other shoulder that, that burden as it were. 

JD Kalmenson: How many sessions? So that's one session, right? 

Willa Hall: So that's one session. And then I would just want to mention that the next thing that needs to happen after that dosing is the integration piece of it. So those are more non-drug sessions. We have three of them. The first one starts the day after that dosing session, they come back or we come back, the therapy team comes back after the participant spent the night, and we start processing what happened, and helping the participant make meaning of what came up in the session. And that's just a huge, I think that's, that's the real workhorse work of the therapy, is helping because once the drug is out of their system, there's often this sense of like, well, what happened? Or I don't feel any different.  

JD Kalmenson: Do they remember? 

Willa Hall: Some. It depends, sometimes. Sometimes, but the other thing is that's another function of the therapy team is to take notes, right. So we are taking notes through it. So we want to capture all that really powerful material for them. 

JD Kalmenson: So you don’t record it?

Willa Hall:  Oh, we do record it for, for adherence purposes. Right.  But we need to take notes because we're not going to look at eight hours of therapy. We want to take notes and we want to have those notes available to us right away. Cause sometimes when somebody's sort of coming down from the session and we start that processing, a lot of times, those notes are really helpful to kind of say, well, it started like this and then this happened and it's a nice thing to do while the person still got a little medicine in their system to sort of start to make sense of like, wow, what happened today?  

JD Kalmenson: Wow. 

Willa Hall: And there's oh, you know, I mean, everybody feels like, no, you did a lot of work today. Participants do a lot of work on MDMA. 

JD Kalmenson: Right? You cannot do five, dose sessions a week as a therapist. 

Willa Hall: No, no, no. I think we're all trying to figure out how many, how many we can actually do. But no, yeah. I had a, one of my co-therapists was doing two in a week and that was a lot. Yeah. So, yeah. I think we're all sort of looking at probably one a week at the most. Right. yeah, it's a heavy load to carry, but exhilarating work too. 

JD Kalmenson: I mean, not only are you sort of jump starting a process that might take a traditional client and talk therapy years and years to uncover, you might even be harnessing and, and, and, and, you know, unveiling dimensions, self that would never be brought to the surface. 

Willa Hall: Absolutely. Absolutely. I know it moves me so much to, to hear those words. I think that's absolutely right. It is. 

JD Kalmenson: Wow, yeah. And in terms of the authenticity of the practitioner in terms of the demeanor and disposition, so of course you're guiding the client and that's incredibly powerful and important, but the client, is, are, are they open and receptive energetically to the practitioner or are they a little bit in their own world? And they're just, you know, you're just sort of guiding them almost like in hypnotherapy? 

Willa Hall: You know, I'm hesitant around words like guide because that sort of suggests that, you know, for instance, I'm in control, I'm taking them someplace, and actually it really isn't that. It's really like you're following closely behind you know, and you're, you're sort of supporting feelings that are coming up including really scary feelings. Like people will go into feelings like wanting to die. We support them in going into feelings of wanting to die or being dead or going just into those dark scary caves, that they've never wanted to go before. So more what we do is we just try to sort of suss out where they are and support that. So, you know, I don't know much about hypnotherapy, but, I do think what I, the little I understand is that hypnotherapy is a lot about suggestion you know, and I'm certain it's suggestions that have been sort of sanctioned by the patient, but we don't do, we have to be really careful about suggestion, right? We don't want to plant anything in a participant. We want to respect their process. And is this extraordinary experience of like, if you can trust a person's process, it will always lead you to where you think they should have gone. Like, it's amazing by the end of the treatment, I'm always like, that's where I wanted you to come to. And they've done it on their own. That part is blows me away. 

JD Kalmenson: Yeah, that sounds like something that, a somatic experience practitioner sharing with me a similar sentiment. And it really sounds similar to what you're saying now where our bodies and our psyches have this uncanny built-in ability to regulate and heal themselves if they're given the opportunity and the right conditions. So when you talk about, you're not guiding, but we're here to create this safe space and with the MDMA intervention and allowing them to lower their guard, and inhibitions, it's almost like you're just really giving the tools for the body to do what it itself knows how to do.

Willa Hall:
 Thank you for saying that. That's exactly right. That's exactly right. There is an innate healing process that we want to help, support. 

JD Kalmenson: Amazing. So it's just an incredible thought. 

Willa Hall: Yeah. It's 

JD Kalmenson: An inspiring thought. You know, so there have been so many studies, I mean, taking a step back from MDMA specifically, but as far as psychedelics go, going back to the 1950s, I mean, maybe even earlier, why do you feel, personally there's been such a national or cultural resistance or reluctance to bring this into the mainstream standards of treatment? Or would you say it's not really a reluctance, it's just figuring out the most responsible way takes so much time? 

Willa Hall: I like that. I like that last thing you said. I think that that's right. I, I actually don't think there's a lot of reluctance now. I think this is being sort of more becoming more and more acceptable, sort of on both sides, more for more liberal-minded and conservative people that this, that this treatment seems to work. And it's done responsibly that, you know, this should definitely become something that, that is available to people, but I do think that that issue of it being, you know, sort of, ushered in, in an ethical and responsible way is a big piece of it, you know, because these are very, very powerful medicines and we do have lots of stories of it being misused and people taking advantage of being taken advantage of. 

JD Kalmenson: What regulatory components do you think would be most necessary to ensure that the therapeutic work is done responsibly? Is there any, like sort of, you know, high level ideas that in the work that you're doing would be just so important in distinguishing, this being done, you know, in a reckless way or in a responsible way? 

Willa Hall: Well, I know that we have to come up with, the right, REMS.  I don't know if you're familiar with that term, the risk evaluation and management, strategies, so that so that we are disseminating this treatment in the right way and minimizing the diversion of this drug. Right. 

JD Kalmenson: So you’re saying who's a proper candidate, who's the right, who's eligible? Is that, is that what you're referring to? 

Willa Hall: I'm referring to, how, okay, so we've got this very powerful drug, right. But what's being legalized isn't the very powerful drug, it's the MDMA assisted therapy. So, there is not going to be a world where people will get a prescription for MDMA assisted therapy and then go to the corner store and pick up their MDMA. That's just not going to happen. This is going to be more like a, like a methadone clinic, right. Where it's dispersed by a provider. And that's, what's likely going to happen is that, the drug will be given to the provider and administered in the context of a therapy session. So that helps with the whole diversion issue. And it helps with people sort of taking it in the, in the manner in which it's prescribed. So obviously that's… 

JD Kalmenson: Not abusing it, 

Willa Hall: Not abusing it, not abusing it. Exactly. And I think the other piece of it has to do with what we were talking about before, about sort of, how do we, you know, kind of create an army of therapists who really are holding this treatment with the integrity that they need to for, you know, for it to be effective and safe for people. And to that end, there is already, a young organization called the American psychedelic, practitioners association, that is going to, I think, try to set the standards for the care and accreditation of providers who are going to offer these kinds of treatments, which I think is fantastic. I mean, having a professional organization like that, I think is essential for any of these new treatments. 

JD Kalmenson: In the research that you've been doing, who is the prime candidate for MDMA therapy, obviously folks who are looking to do deep work, but, would somebody who has been struggling with mind altering substances in the past, be precluded given, the propensity to confuse this healthy sort of intervention with unhealthy recreational use of drugs or other, you know, I, I, we, we're talking about PTSD, but asking, you know, if somebody has a history of substance use disorder, would that preclude them from being an eligible candidate? 

Willa Hall: No, it, doesn't. Not a history of substance, use disorder. If they have an active substance use disorder. Yes. that it needs to be, it needs to be, if they have a moderate to severe substance use, disorder, then that needs to be in remission for the last 12 months, if they have sort of some mild issues like mild alcohol use disorder or mild cannabis use disorder, we would still take them. So that's part of our screening process is we sort of assess where they are with these, you know, drugs

JD Kalmenson: So you're mainly focused on PTSD, not necessarily on treatment resistant, depression and other diagnoses. Right. Is that right? The, the focus for 

Willa Hall: The phase three studies? Yes, we're focused on treat chronic treatment resistant PTSD, but there are studies that are going on, that are looking at it for other clinical indications, like eating disorders, social anxiety, autism, and I think I'm certain there's one on depression 

JD Kalmenson: Autism is incredible. That would be a first, I mean, you're, you're, you're entering into a whole other domain there. 

Willa Hall: Yeah. There was a really wonderful study, out of UCLA, that looked at, the effectiveness in addressing social anxiety in folks with autism. And it was very, very, you know, it really suggested that it could be a very effective treatment. So, you know, these studies are small because the work is so, clinical heavy, you know, like we've got two clinicians for every participant and then there's, 

JD Kalmenson: It's costly. I'm sure. Right. You rely on, on grants. 

Willa Hall: We do a lot rely on mostly grants and also, individual contributions. Yeah. 

JD Kalmenson: And is the process very difficult to initiate a study? I mean, from scratch, I mean, is, is that in and of itself hard from a bureaucratic paperwork perspective? 

Willa Hall: Well, you know, my partner in, at Nautilus and I have been, , preparing a, , clinical protocol to treat, , to treat healthcare workers affected by their work on the front lines of the pandemic with MDMA assisted therapy. And yes, it's very hard to put together a protocol we're about to…

JD Kalmenson: That's a beautiful initiative, you know, of the workers in general, there's, there's so much burn in turn. It's just, just, it's hard to, to, you know, the resiliency on the stamina side. And I, you know, just one thought that, that it makes me so excited about the MDMA. The prospects is the sustainability of the care because you're not just bringing somebody to a certain space, a certain awareness, a certain degree of clarity, but the integration component is really something that makes it so special and unique because you're really not only doing what everybody else does in talk therapy, you have this added sort of powerful foundation to draw upon. And then, you know, sort of the, regular standard traditional talk therapy, which is the holy grail of therapy is happening. And that's probably what makes, what connects the dots to take this extraordinary transcendental experience and integrate it into lifestyle, into your, your, your regular daily consciousness. 

Willa Hall: Absolutely. I think that's the real heroic work is the integration. Yeah. And that's, that's, really, I think what makes it so effective, and again, that's where you really need that good therapy rapport, right? You need to be a trustworthy, person for that for the participant to really sort of get, you know, have that buy-in of like, you can help me with this, you know, right. You were there and you get it and you have the wisdom and the,  you know, care that I need to sort of help me understand this 

JD Kalmenson: Amazing. And do participants and clients come back in for a tune-up. 

Willa Hall: The protocol that we use now are three separate dosing sessions. And we are not allowed to, to do more than three, three dosing sessions interspersed with those non-drug sessions. But you know, once again, this gets legalized, we'll, there will be some leeway for us to, if we feel like there's more work to be done. And I have certainly worked with people who I feel like, oh, I wish we could do some more MDMA sessions with them because the trauma is just so deep, there's so much more work to do to excavate, but once it's legalized, we will have more leeway to do that, although I do think taking a pause and seeing what can be worked with just from those initial three is a good idea. And then kind of, as you're suggesting, sort of come back for a tune-up, you know, or, or continuation, of the work. Yeah. Because it's it over time people continue to sort of work on the experiences. Right. So even if they leave feeling kind of not finished, I have noticed over a course of a year or two, that there's more work and more processing that they do, to sort of understand what happened 

JD Kalmenson: And build on that progress. 

Willa Hall: Yes. 

JD Kalmenson: Yes. Are there any physical side effects? Are there any from MDM, on you know, the purely physiological withdrawal side of things, is there discomfort, is there any, anything that, you've encountered? 

Willa Hall: There are certainly side effects that we see in the session jaw tightness and, you know, feeling, hot or, or sort of sometimes some chest pain. And oftentimes afterwards there's a headache, and a certain amount of sleeplessness just that night afterwards. But other than that, there's no, there's no sense that there's some withdrawal going on. 

JD Kalmenson: Are there physical preparations that go in? I know, like, for example, with Ayahuasca they, you know, there's a whole eating, sort of, clean preparatory cleansing of weeks before, a couple weeks before no meat, no, this, no, that. Do you have an equivalent for that in MDMA or it's not, not quite like that?

Willa Hall: No, not a diet. And we don't, we don't suggest supplements, although I've been hearing about those more recently. But one, one important thing that most people don't know is that, when you undergo this treatment, you cannot be on your regular antidepressant regimen, or most psychotropics are, have to be discontinued. So that's a whole thing, right. Because we have a lot of people on, antidepressants and they've been on antidepressants for sometimes decades, so we have to taper them off. 

JD Kalmenson: And why is that? 

Willa Hall: Because I think it works on the same serotonergic networks.  And it dampens the effect of the MDMA for people to be on their SSRIs. So that that's tough. 

JD Kalmenson: Yeah. Definitely.

Willa Hall: And you don't need that with ketamine, which is why ketamine also is sort of has that advantage is that you can stay on whatever medications you're on and still, you know, feel the effects of ketamine. 

JD Kalmenson: Right. Wow. So what do you see as the future potential of MDMA assisted therapy and five years from now? What would you like to see? I mean, maybe even less than five years, is there any indication of the FDA making some movement within a certain predictable timetable or it's still, is it still open? 

Willa Hall: Yeah, well, we thought it would be legal by now, but then COVID happened and delayed everything, but we are now looking at, I think the end of 2023 for it to be legal. And I'm very interested in being part of creating a clinic here in New York City where we offer this treatment. We've already found out that it's very likely that insurance companies will reimburse the cost, of this treatment, especially when, clients have, meet that diagnostic category of chronic treatment resistant PTSD. For people who don't have that clinical indication who maybe just have sort of depression or, or stress, or, you know, something else that their therapist wants to still move ahead with a MDMA session, that would probably be, have to be out of pocket. But yeah, I'm, I mean, I am excited about this being something that, that is available. 

JD Kalmenson: So I'm super intrigued. Do you see it dramatically changing the entire behavioral health system in the sense that for folks who are struggling with PTSD, they will no longer be going to residential inpatient treatment, but this might be the solution? Or do you see like everything in life, you know, there is varying degrees of acuity and, you know, there has to be a certain degree of functionality for somebody to be able to have the MDMA intervention be the sort of soul intervention that helps them get back on their feet. 

Willa Hall: I think that they have to have a certain level of functionality. And I also think they have to have a certain level of support in their lives. And that piece of this becoming more and more clear to us and, and the whole piece of sort of what kind of aftercare, is, is available to people after a treatment like ours, that, that that's a huge absence right now that we really need to address. Because it's an extraordinary experience that people have and they, they get an extraordinary level of care and then they're kind of on their own. And a lot of times, you know, a lot of what they've learned and the insights they've gained do not necessarily go easily with the kind of life that they're living, the relationships they're in, the jobs that they're in. And so there's a real disruption to their life. So I have to say, I, I feel like initially, at least, and this, I say with some chagrin, the rich will get richer. The people who have that functionality and that support will probably be the first ones to benefit. But, but there are, there are these other populations we want to reach. And we, and I don't want to, I don't want us to take our eye off of that. You know, there's people who, who really are like suffering at a sort of more severe level. 

JD Kalmenson: Yeah. Imagine utilizing this in the psych ward, imagine utilizing this in a residential program. Coupled with the 24-hour subsequent monitoring and support that this, I mean, that's such a natural, organic fit. It's like, it would be incredible. 

Willa Hall: I'm with you. Absolutely. With you. Yeah. 

JD Kalmenson: Unbelievable. Thank you so much, Willa for sharing your fascinating knowledge, passion, insight, and wisdom with us. It was such a privilege to have you here today. 

Willa Hall: Oh, thank you so much for having me. This is fun. I really appreciate, I love your questions. So thank you 

JD Kalmenson: Right on. And thank you audience for joining us today. I hope you enjoy today's episode of Discover U as much as I did. At Montare we want you to know that you're not alone on your journey and to find out more about our innovative treatment programs, you can visit us and listen to this podcast on iTunes, Spotify, or wherever you get your podcasts. Wishing you all radiant health and a safe and fulfilling day. See you next time.