Tiffany: Hi everyone, My name is Tiffany and I am Innerwell's Head of Operations. I want to thank everyone so much for joining us today. I also want to introduce you all to Dr. Mike Cooper, who is a board certified psychiatrist and Innerwell's Medical Director. He will be running this webinar and answering all of your questions.

Before we get started, I also just wanted to remind everyone that this webinar is a private, safe space to learn about ketamine treatment for depression, anxiety, PTSD, and other conditions. You'll actually be able to ask questions via Zoom's Q&A feature anonymously and if you do want to ask anonymously, just make sure you click into the ‘Ask Anonymously’ feature as it's not the default, and Dr. Cooper will have some time at the end of the webinar to answer these questions. I'll also just drop this reminder periodically in the chat function as well.

Mike, do you want to get started? 

Mike: Yes, sounds good. Thank you, Tiffany. All right, everyone, welcome! Appreciate you joining my talk today and considering Innerwell for your mental health treatment. This is the agenda; I'm going to go over my background, talk about psychedelics and psychiatry, how Ketamine fits into psychedelics and psychiatry, and then Innerwell's treatment programs with Ketamine specifically. Then we'll have a little bit of time for Q&A at the end. 

Disclaimer: this webinar is for educational purposes only, and it's not intended to be formal medical advice. 

So a bit about my background; I first became interested in ketamine while I was working as a med student and doing research at LIJ. We were looking at using ketamine as an anesthetic for patients undergoing electroconvulsive therapy to see if it would enhance the antidepressant response of ECT. That's when I first sort of discovered that ketamine has antidepressant properties. Prior to that, I knew about ketamine as an anesthetic and a pain relieving molecule, but not as an antidepressant.

From there, I went to NYU for my psychiatry residency, and I was a research therapist on a trial using psilocybin assisted psychotherapy for alcoholism. And I was really amazed by how rapidly psilocybin could facilitate behavioral change. And that sort of got me further involved and invested in psychedelic assisted therapy and psychiatry.

Then I became certified in ketamine assisted psychotherapy, and from there I moved to the East Bay and managed a consult liaison psychiatry program at Alameda Health System, where I was administering IV ketamine to patients who were hospitalized with terminal illness and other types of medical conditions and I was using IV ketamine to help alleviate their depression, anxiety. And again, it was really remarkable how fast ketamine could work in terms of helping patients. 

From there, I went and started a virtual ketamine assisted private practice with a colleague of mine in California. Then I became Associate Medical Director of Valera Health, which is a telepsychiatry company nationwide, and then since last September I’ve been the Medical Director of Innerwell, which we'll be talking more about today.

Psychedelics in Psychiatry

All right, so, a brief overview of psychedelics and psychiatry. There's four major classes; there's the classic psychedelic class which is LSD, psilocybin, Mescaline Ayahuasca that work on a serotonin two A receptor. There are the intactogens or empathogens with MDMA alternate ecstasy being the most notable one.

Then there's the dissociative psychedelics, which ketamine is the most notable dissociative psychedelic and that's what we're focusing on today and what we focus on at Innerwell and under the atypical hallucinogens like Ibogaine and Salvia. 

So there are a number of clinical studies ongoing with psychedelics at major Ketamine centers throughout the US and the world. These are five ketamine studies that are ongoing right now for depression, alcohol use disorder, suicidal ideation, and treatment resistant depression. And again, there are a number of other psychedelics being investigated worldwide right now. 

This is an example of how a patient would undergo psychedelic assisted therapy in a research study. Typically there are two therapists who sit with the patient while the patient lies down on a couch. They put an eye shade on and they listen to music, and they have an introspective journey with the psychedelic. The therapists are there to provide guidance and support throughout the session and this is similar to the model that we use with ketamine assisted psychotherapy at Innerwell. 

Overview of Ketamine Treatment

All right, so now, an overview of ketamine. Ketamine was first discovered in 1956 and was approved for use in the US in 1970 as an anesthetic agent. It was used extensively throughout the Vietnam War due to its safety profile. It's on the World Health Organization's list of essential medicines and it's available as an inexpensive generic medication. Over the past 50 years, it's been safely administered to millions of adults and children and then over the last 30 years, it's been studied quite extensively for the treatment of psychiatric disorders; depression, anxiety and PTSD. 

It's being delivered by a number of different methods; intravenous, intramuscular, intranasal and oral. Here at Innerwell, we use the oral method for a number of reasons, which I'll get into. Also to note, intranasal ketamine, known as Spravato, was FDA approved for treatment resistant depression in 2019, as well as major depressive disorder with suicidal ideation in 2020.

This is a complex graph showing the mechanism of action of ketamine. As you can see, it works on a number of different neurotransmitters and neural pathways in the brain. The long and short of it is that downstream of all these pathways it leads to neuroplasticity, which is the brain's ability to form new connections to heal itself. It helps the person who's taking ketamine become more open to behavioral change and new experiences. Also downstream of all these pathways is the antidepressant properties of ketamine. The other thing to note is that these pathways involved with ketamine are much different than traditional psychiatric medications like Prozac.

There are two major categories of ketamine's effects which are helpful to think about when you're undergoing ketamine treatment. At the lower range, it tends to put patients in a kind of a psycholytic or trance state where they may feel more relaxed, like they had a glass of wine, more sociable, able to access difficult memories and emotions and talk about them in an open manner. Then as you move to more of the moderate or higher dose range of ketamine, it becomes more psychedelic. There can be perceptual changes, complex visual imagery when you have your eyes closed, colors that go with music, it can be a sense of merging or oneness of your environment and with the universe and sometimes these mystical experiences and both categories of effects can be very healing for a variety of patients, depending on what they're presenting with. Here at Innerwell, we start with a low dose and we carefully titrate the dose depending on how the patient's responding to it and what their program goals are for treatment. 

The most common side effects of ketamine are dizziness, headache, blurry vision, and grogginess, not all patients have side effects, some patients have no side effects, but those are the most common ones. If you do have side effects, they only tend to last one to two hours after taking ketamine. Ketamine can also cause euphoria and dissociation, which are classically thought of as side effects. But if you're able to prepare for the experience adequately and sort of embrace the euphoria and the dissociation that can come with the Ketamine experience, that can actually be part of the therapeutic psychological benefits of ketamine.

Ketamine can also slightly raise blood pressure in about 20% of patients and because of that, we require all patients to check their blood pressure prior to beginning each ketamine session to ensure that's within the normal range. Also, because ketamine can cause nausea in a small percentage of patients, we ask that all patients fast for 3 hours prior to each Ketamine session to reduce the risk of nausea. Water and other fluids are okay to drink leading up to the Ketamine session.

Very rarely, ketamine can cause bladder inflammation, liver inflammation and cravings for the drug but these rare adverse events have not been commonly observed in a clinical setting. These are more often observed in individuals who are abusing high doses of ketamine daily on a recreational basis.

As I mentioned before, there are multiple routes of taking ketamine. Here at Innerwell, we use the oral sublingual route with tablets. We find that the oral route is the most comfortable route for patients. Patients can take ketamine tablets at home, they don't have to commute 2 hours to a clinic and get hooked up to an IV and wait for the medication to have an effect and then have to commute another hour back to their home. So the oral route is inexpensive, it's easy to use and it's very safe and comfortable for the vast majority of patients. Also, research studies have demonstrated, and our clinical work has demonstrated that the oral route is as efficacious as the other routes of administration.

This is a helpful graph showing the duration of effects of ketamine. You can see here that the drug takes effect in about ten minutes and then for about ten minutes more you'll be at the peak of the experience, which lasts on average, 20/30 minutes, and there's about a 20 minutes comedown period. So the entire experience is about 60 minutes in duration, regardless of the strength of the dose and then patients will typically feel back to their baseline in about 60 minutes after that. Then you'll note that there will be a lot of days afterwards when you have an enhanced mood, lots of antidepressant effects going on. You feel a bit more open to making positive changes in your life and these effects of ketamine can last for days, weeks, and even months after a single session, which is pretty remarkable.

So the antidepressant effects of ketamine, this slide just goes in a little bit more detail about them. Many patients report feeling an improvement in their mood within 4 hours of taking ketamine and this improvement in mood can last seven to 14 days on average, but sometimes as long as 30 days. Clinical studies have shown that taking ketamine twice weekly or weekly for a period of time can result in more of a sustained improvement in mood. Ketamine has also been shown to be effective as an antidepressant in patients who have failed many other traditional psychiatric medications like SSRIs, as well as patients with bipolar depression.

About a third of patients with treatment resistant depression can actually achieve remission or otherwise known as no symptoms with ketamine treatment and about two thirds of patients with treatment resistant depression demonstrate a clinical response, or in other words, a significant improvement in their mood from a single dose of ketamine and then it's been shown in the studies that there's a higher rate of response and remission with repeated ketamine sessions. The research has also shown that psychotherapy, when combined with ketamine can enhance and extend the duration of ketamine's efficacy.

Ketamine has also been shown to reduce suicidal ideation even within 4 hours of a single treatment session. And this reduction in suicidal thoughts could persist three days or longer. And this is quite remarkable. There are not any other psychiatric medications that can do this as quickly other than lithium and Clozapine, but those can take many weeks to months to have an effect on suicidal ideation.

It's a bit of a busy graph or slide here, but I just want to show three important research studies of ketamine. The one in the top left was the first IV ketamine infusion study that shows a significant decrease in depression scores after single ketamine infusion and this decrease in depressive symptoms occurs quite rapidly and trends down all the way 48 hours after the single infusion.

In the bottom left there is an at home oral ketamine treatment study done last fall with a couple thousand patients and you can see there's quite a significant decline in depression and anxiety symptoms within four treatment sessions of ketamine at home. 

Then on the right here, also another at home study that was done last fall with 1000 patients showing that ketamine can rapidly decrease depression and anxiety scores within three to six ketamine treatment sessions at home.

This is an important study that was done that also shows how when ketamine is combined with talk therapy you can have quite a significant and robust response in both depression and anxiety symptoms.

These are just some early data of the several hundred patients we treated here at Innerwell. It also mirrors what's been seen in the research studies I just showed, where many patients are reporting quite a significant decline in their depression and anxiety symptoms within four weeks of treatment and a large number of them are reporting even a significantly more decrease in depression, anxiety symptoms ten weeks from the start of their treatment at Innerwell, which, again, is much more significant and rapid than what you get with traditional psychiatric treatment.

Innerwell’s Treatment Programs

All right, now we'll take a little bit of a deep dive into our specific treatment programs at Innerwell. Many of you have probably seen our website. I really like this quote from one of our patients in California. She had been battling depression for several decades and tried a number of different medications, but nothing compared to ketamine has had such a rapid and profound effect on her, and her ability to experience joy in her life again, is quite remarkable.

So the difference between our at-home practice and other clinics out here that are offering at-home ketamine treatment is that we utilize expert psychiatric clinicians, nurse practitioners and physician assistants, as well as licensed psychotherapists. All of our clinicians have been trained in ketamine assisted therapy. All of our psychiatric clinicians are certified and supervised by board certified psychiatrists who are also trained in ketamine assisted psychotherapy.

In addition to thousands of hours of supervised care that our therapists have given, they've also undergone a seven week intensive training course in ketamine assisted psychotherapy through a company called Fluence, who's quickly becoming sort of a nationwide leader in psychedelic assisted therapy. So, unlike other at-home ketamine practices, where you might work with a facilitator or guide who are typically unlicensed staff, you'll be working with licensed experts here, whether that's our psychiatric clinicians and or our psychotherapists. We also are very big on data and technology. We use our technology and data to empower our clinicians and our patients to deliver very personalized treatment programs here.

Just a few other things to highlight the difference between us and other clinics in this space. We're very convenient. You don't have to go in person to an IV clinic and have to commute to the clinic and set aside all that time from your day and work. We're very flexible because you can take oral ketamine at home, you can schedule your treatment sessions when they work best for you, not just when a clinic is open, because you're taking them at home. You have the comfort of your own personal space to set up for your experiences. And also doing these sessions from home reduces the cost compared to in person treatment.

This is just our page showing our roster of clinicians, again, a variety of NPS, PAs, and licensed psychotherapists. We have two major plans available on our website, there's our 8 Dose Foundation plan and our 24 dose extended plan. The majority of patients start with the 8 Dose Foundation plan because that quite often leads to significant response for many patients. Patients who have been suffering from depression for decades or longer can sometimes benefit from a longer treatment program and those tend to be the patients who would select the 24 dose extended. Plan.

This is our Innerwell box that contains everything you need for your journeys. We have our comfy Innerwell eye mask, blood pressure cuff and journal, and pen and iPhone stand, and you'll receive your first 2 doses of Ketamine in the Innerwell box.

So as far as our registration process, you'll go to our website, click on the Get Started button. You'll take our two minute screener. Once you complete the screener, then you can select either the 8 dose foundation plan or the 24 dose extended plan. Keep in mind though, that if you're not sure which plan will be right for you, you can select one or the other and then once you meet with your psychiatric clinician, you can discuss your condition in more detail. You can always switch from one to the other plan at the beginning of treatment. You also have the option of adding on psychotherapy sessions and our psychotherapy bundle, which includes a number of psychotherapy sessions to begin treatment here.

This is just a flowchart showing kind of how you navigate our 8 Dose Foundation plan. Again, you take our screener and our digital intake. You make your first appointment with your psychiatric clinician. If they deem you suitable for treatment here, then you'll receive your first two doses of Ketamine as well as the Innerwell box.

Also concurrently, you can schedule appointments with one of our psychotherapists, if you want to add-on a psychotherapy program to your package here. Then after your first two Ketamine sessions, you'll have your first follow-on appointment with your psychiatric clinician. Then after that, depending on how you did with your first two sessions, you'll receive your next six treatment sessions. Then you'll undergo those treatment sessions at home and then you'll have your final Capstone appointment with your clinician to discuss how you did overall in the program and whether you might benefit from ongoing Ketamine treatment or not. All patients have the option to continue working with their psychotherapist here, even without taking Ketamine, after they finish our program.

This is just a photo showing an example of what an at-home session can be like for a patient. Typically, patients will lie on the couch and put an eye mask on. We require all patients to have a sitter or support person physically present with them; a loved one, a neighbor, a friend, a partner, doesn't have to be the same person every week. They don't have to be right next to you throughout this session but we do want them to be within earshot of you if you need them to come back over and check on you and give you some support. Some patients prefer to have their sitter sitting next to them during the experience.

These are the common conditions we treat with Ketamine; depression, anxiety, bipolar disorder, PTSD, OCD and alcohol use disorder, as well as grief reactions and difficult life transitions that can come with depression, anxiety. 

These are contraindications of Ketamine treatment, particularly history of severe cardiovascular disease or severe liver disease, seizure history, any active ongoing substance abuse, active mania symptoms, or any history of psychosis would be contraindications.

Ketamine is very safe to take with the vast majority of medications. These are a few that we'd ask you to hold on the same day of your treatment sessions, but otherwise you can continue taking your other psychiatric and medical medications as normal. 

This just summarizes our oral treatment method. The oral tablets we use range in strength from 50 to 400 milligrams. They usually arrive within two to three business days to your home. Again, patients hold the tablets in their mouth for about ten minutes and switch them around, and then they spit them out. And then you have about 60 minutes long experience, and then you're back to your baseline within 1 to 2 hours afterwards.

We recommend not to drive or operate heavy machinery after your treatment session. Then again, as you go through your program, you'll be meeting regularly with your psychiatric clinician for 30 minute follow-up appointments to check in about how you're doing. 

So, Ketamine feels like a very peaceful state. It's an opportunity to take a step outside of yourself and sort of reflect on your life and your situation in a different manner from a different perspective. Sometimes you can help patients connect the dots of their experiences to kind of help them understand their situation in a better light. Many patients report gaining access to memories that have been suppressed or repressed, which can be very healing to talk about and process. 

So this psychological experience with Ketamine tends to be very healing and helps lead to the antidepressant benefits but on top of the psychological experience, ketamine is working in the background of the brain with neuroplasticity and alleviating depression on a biological level.

So when you combine the psychological and the biological mechanism, you have a very powerful tool through Ketamine. 

We offer optional in person treatment in a number of clinics listed here in Manhattan. We provide in person guided sessions with oral Ketamine for patients who are interested Although at other locations, you can have consultations and follow up visits with the clinicians if you prefer.

Again, we have a number of psychotherapy options for all patients. Every plan includes one psychotherapy session to get started, and then you can add on additional sessions if you want to continue working with a therapist. This is the model we use for psychotherapy, and this is built off of the standard psychedelic assisted therapy model, where we have preparation sessions, therapist guided medicine sessions, and then integration sessions. In our program, you can opt to add in any of these sessions along your journey as many times as you'd like. 

And again, this slide just talks about the expert psychotherapy add on program. If you want to bundle in a number of psychotherapy sessions in one go, you can pay for that upfront for a discount, or you can add on psychotherapy sessions throughout your journey for an additional fee.

These are some of our pricing for sessions. You can add integration sessions for $165 for 50 minutes, and you can do psychotherapist led Ketamine experiences, which are 120 minutes for $375. We offer a variety of payment options, including credit card, HSA, FSA cards. You can get a super bill for every visit, which you can submit to your insurance provider for out of network reimbursement if your plan offers that and these are the most common billing codes we use here at the bottom of the slide. 

So if you make your first payment, you'll schedule your first appointment with your psychiatric clinician, they'll review your medical and psychiatric history, and if they deem you suitable for treatment you'll get your first two Ketamine treatments in the mail with the Innerwell box, and then you'll follow up again with your psychiatric clinician after those first two sessions. If for any reason you're deemed unsuitable during your first psychiatric clinician appointment, you're eligible for a full refund.

Just want to show a few screenshots of our app before we dive into the Q&A. We offer a comprehensive daily mood tracking and journal feature in our app so patients can check how they're doing with their mood every day and journal and reflect on how they're feeling.

We offer a number of educational modules, you can find here about preparation, integration, how to work with Ketamine, how to work with a therapist during Ketamine sessions. We have a number of curated music playlists with different tones and melodies, depending on the kind of session you're looking to have, and many patients that report enjoying kind of rotating through a number of these different playlists. Then we also have a number of guided meditations by Henry Shukman, who's a Zen master in the UK, who's graciously recorded a number of guided meditations that you can use throughout your program here.

Then this is your Journey tab, where you can set program goals for yourself. You can track how you're doing and how you're progressing towards those goals throughout your journey at Innerwell. 

Then we also track your symptoms. We look at your depression, your anxiety, how are they doing over time. We can track them here on the app and then this also feeds back to our clinician so they can fine tune your care to make sure you're getting the symptom relief that you need.

That's it. These are references and again, I want to thank everyone for coming out today. We'll have a few minutes now for questions after a few more words from Tiffany.

Q&A Session

Tiffany: Hi, everyone. I want to echo Mike's comments, thank you so much for coming out today. I did just also want to point out that I dropped in the webinar chat a link to our two minute screener and also our new patient discount code.

So it's save ten once you go through our screener you'll be prompted to check out if you go through the screener. Once you get to check out, feel free to use that new patient discount. Thank you so much.

Mike: Thanks, Tiffany. All right, so I'll address some of these questions that are coming through.

So someone says they've been receiving IV ketamine for anxiety for about two months, but their clinic will be closed for a few weeks, so they wanted to try Innerwell during that time.

In terms of that question, a brief program. So if you wanted to maybe work for two or three weeks at Innerwell on a treatment program, we do offer a two dose intro plan for selected patients, depending on their circumstances. If you're interested in exploring the two dose plan option you can email our care team and we can talk to you about that option. 

Then someone asks, how are dose amounts adjusted if needed if you send out the second shipment in quantities of eight. 

So the first two doses are considered typically dose finding sessions where you kind of gauge the patient's sensitivity to ketamine. We typically start with the lower end of the dosing spectrum to see how sensitive they are and how they respond. Then based on those first two sessions, then we can titrate the next six sessions accordingly. Typically with those first two doses, you're able to take a higher dose for the second session, depending on how you respond to the first session, and your clinician will explain how to do that during your intake with them.

Next question, can I work with my existing therapist while working with Innerwell?

Absolutely. We definitely encourage continuing to work with your current therapist, especially if they're supportive and open to you undergoing ketamine experiences. You can have your experiences through the treatment program at Innerwell, and then you can meet with your outside therapist and process and integrate these experiences with your current therapist.

So many of our patients do that. Some of our patients want to work with a more specialized ketamine assisted therapist in our program and then have that therapist collaborate with their outside therapist, that works well for a lot of people. For others, it may be too many cooks in the kitchen and they want to just focus on one therapist, but we're very flexible with that option.

What dosage milligrams do most patients start with?

So most patients who are psychedelic naive or have never undergone any ketamine treatment willl start with 100 milligrams or 200 milligrams, and then we can titrate up from there, with most patients averaging 400 to 600 milligrams in the therapeutic range by the middle of the program.

By oral route, do you mean sublingual or swallowing the medicine?

So we use these oral dissolving tablets that you hold in your mouth for ten minutes, and you swish around a couple of times a minute. The medicine is absorbed under the tongue and through your cheeks over that ten minutes, and then you spit out the medicine, and then the effects come on and last about 60 minutes.

That works for the vast majority of patients. For some who have quite short experiences. If they have fast metabolisms for whatever reason, on a case by case basis, we might advise them to try swallowing the medicine after swishing for ten minutes but that's rare, and most patients do quite well with the swishing method and then spitting out the saliva after ten minutes.

Will I be able to start at the sublingual level now that I've been receiving IV treatment? 

For patients who are currently receiving ketamine elsewhere, we don't start them on ketamine treatment at Innerwell unless they're ready to stop the ketamine treatment they're getting elsewhere. We do have some patients who have been on IV ketamine treatment for a period of time but dislike the cost or the inconvenience of going to an IV clinic, and they switch over to us and we can convert their IV dose to the oral dose, and then they'll continue receiving oral treatment with us.

Do patients typically stay on ketamine indefinitely, or can they weigh off?

So our goal is to not have patients become dependent on ketamine. Many patients feel much better after eight sessions, but some portion of patients will benefit from a maintenance program for another two or three months following the initial eight dose plan. Then probably a third of patients will benefit from a six month or longer program, depending on how chronic their depression, anxiety, or PTSD was before starting treatment at Innerwell. So it's kind of a patient by patient basis, but again, many patients have an initial series of Ketamine and do quite well and don't need to continue. Another third will benefit from a short maintenance program, and then others will benefit from a bit of a longer ongoing maintenance program with ketamine until their symptoms have been significantly reduced for a sustained period of time.

Are all appointments virtual?

Yes, all appointments are virtual by default, but in a few cities in California as well as in New York, we do offer in person appointments as an option if patients would prefer to be seen in person. Now, at our clinic in Manhattan, we can also do therapist guided sessions in person for patients who would like to do that.

Our other clinics in California for instance, we don't offer ketamine sessions in the office, but you could see your psychiatric clinician in person for the consultation, for the follow up visits. Some patients prefer to do that, but for the majority of patients, it's all virtual at-home care through zoom.

All right, everyone, great questions, and again, appreciate all of you coming out today, and thanks for considering Innerwell for your mental health treatment. Wish you all the best, take care!