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Addiction is killing us. Over 100,000 Americans died of drug overdose in the last year, and over 100,000 Americans died from alcohol use in the last year. We need to include addiction medicine as a part of everyone's practice! We take topics in addiction medicine and break them down into digestible nuggets and clinical pearls that you can use at the bedside. We are trying to create an army of health care providers all over the world who want to fight back against addiction - and we hope you will join us.*This podcast was previously the Addiction in Emergency Medicine and Acute Care podcast*
Addiction Medicine Made Easy | Fighting back against addiction
Treating Opioid Withdrawal—With the Ear???
Discover how stimulating specific points on the ear can dramatically reduce opioid withdrawal symptoms through an FDA-approved device called the ST Genesis. Shelley Halligan, President of Speranza Therapeutics, explains the science behind percutaneous nerve field stimulation and its remarkable effects on patients struggling with addiction.
• The device works by targeting cranial nerves in the ear to activate the parasympathetic nervous system
• Small electrical pulses delivered continuously for five days can significantly reduce withdrawal symptoms
• Clinical applications include shortening the waiting period before starting Suboxone treatment
• The technology may help prevent precipitated withdrawal, a major barrier to recovery
• Patient case studies show dramatic symptom reduction within minutes of application
• Preliminary evidence suggests effectiveness for alcohol and other substance withdrawals
• Research is underway to develop a 10-day version specifically for fentanyl withdrawal
• The device empowers patients by giving them more control over their treatment timeline
• Implementation in emergency settings could transform overdose follow-up care
• Healthcare providers can receive free training to incorporate this technology into practice
Visit speranzatherapeutics.com to learn more about the ST Genesis device and provider training opportunities.
To contact Dr. Grover: ammadeasy@fastmail.com
Welcome to the Addiction Medicine Made Easy Podcast. Hey there, I'm Dr Casey Grover, an addiction medicine doctor based on California's Central Coast. For 14 years I worked in the emergency department seeing countless patients struggling with addiction. Now I'm on the other side of the fight, helping people rebuild their lives when drugs and alcohol take control. Thanks for tuning in. Let's get started.
Speaker 1:Today we are going to be talking about how stimulating the ear can treat opioid withdrawal. Now you might be thinking wait what? How does stimulating the ear treat opioid withdrawal? And I will tell you. We will go into detail during this episode. Today I speak with Shelly Halligan from the company Spiranza Therapeutics about a device that they have which is FDA approved to treat opioid use disorder and opioid withdrawal. It's called the ST Genesis and I have used it in my practice. Just to be clear, I have no financial ties with the company, but I have used their device to take care of my patients.
Speaker 1:Let's go through a few background terms and concepts to make sure that we are all on the same page to understand the discussion that goes on in this episode. First, our body has two opposing parts of the autonomic nervous system. The autonomic nervous system is the part of our nervous system that controls our involuntary functions. We have the sympathetic nervous system, and when it's active, this part of the nervous system is very stimulating. It's our fight or flight response. Withdrawal is a fight or flight response. The other part is the parasympathetic nervous system, and when that one is active it's calming. It's the response that our body uses when the body needs to rest and store energy from the food we eat. It's often remembered as the rest and digest system, and stimulating the ear, it turns out, helps us to switch between these two systems, which is how it helps withdrawal. Next, shelley mentions a term called COWS, and this is an acronym for Clinical Opioid Withdrawal Scale. It's how we measure how severe a person's withdrawal is. The higher the number, the worse the withdrawal. And finally, I am pretty sure that we all know about precipitated withdrawal, but let's go over it to make sure that we're all on the same page.
Speaker 1:Precipitated withdrawal is when a medication puts a person into opioid withdrawal. Naloxone, also known as Narcan, will do it when it's given to reverse an overdose, and buprenorphine, which is in suboxone and subutex, can also cause precipitated withdrawal. People need to wait for a period of time after their last dose of opioid before they are ready to take buprenorphine. Otherwise buprenorphine will cause precipitated withdrawal, and with that let's learn how stimulating the ear can treat opioid withdrawal, and it could also potentially treat other withdrawal syndromes too. Here we go. Treat other withdrawal syndromes too, here we go, all right, well, it's good morning my time and good afternoon your time. Why?
Speaker 2:don't we just start by having you tell us who you are and what you do? Absolutely, it's very nice to be here, dr Grover. So my name is Shelly Halligan, I'm a board-certified psychiatric, mental health nurse practitioner and I am the president of Speranza Therapeutics.
Speaker 1:How does one become president of a therapeutics company?
Speaker 2:Well, I have been in the addiction space treating patients and overseeing innovations, I would say, for treatment centers in the addiction space. I got introduced to Speranza Therapeutics in 2019 when I was the Senior Vice President for Aware Recovery Care for Medical Affairs and Sal Raffinelli, who is the CEO, approached us to use their ST Genesis device in our in-home withdrawal management program.
Speaker 1:I'm always amazed there's such interesting paths we all take in our careers, absolutely so. You mentioned the ST Genesis device. I have used it on one of my patients. Okay, tell me what it is?
Speaker 2:It is a percutaneous nerve field stimulator that is applied externally to the ear and we have certain locations on the ear that we target in order to stimulate the cranial nerves to address opiate withdrawal.
Speaker 1:How did this technology get discovered? I mean, I'm going to try to be funny here. I love the kind of the accidents of human history Like, hey, a mold grew and we found penicillin. Right.
Speaker 2:Right. Well, it's very old medicine if you think about acupuncture and being able to address this. So it's based in that and it is really incredible the way that it works. I know when I was first introduced to the device, I'll say I was very skeptical and I thought how this is going to work on my patients that are experiencing these extreme withdrawal symptoms. This was right. When we saw a lot of peak of fentanyl, the turn from using heroin to fentanyl and, as you know, working in addiction medicine, we were having a very difficult time treating the significant withdrawal symptoms and the prolonged withdrawal symptoms and even starting patients on Suboxone or other medications. So when I was approached with this device and I was explaining how it worked, I said, okay, let's see if this thing really works. And we tested it out and it did.
Speaker 1:What's the difference between actually just stimulating an area with acupuncture versus nerve field stimulation?
Speaker 2:Great question. So acupuncture usually has a session. So a patient goes in I've actually used acupuncture before for back pain and you're laid on a table and you have acupuncture and then the noodles are removed and you leave. Our device stays on and pulsating for five days. So real big difference. A patient with withdrawal symptoms, as you know, doesn't have just a moment in time or an hour worth of withdrawal symptoms. It lasts for days. So they're going to need those symptoms addressed for a longer period of time and one session of acupuncture. Although it's helpful and it relieves a lot of things, it's not going to give them long-lasting relief like our device.
Speaker 1:So make sure I get this right. There is some sort of nerve field in the ear that, when it's stimulated, suppresses opioid withdrawal. I've heard of auricular acupuncture for withdrawal and your device uses this physiologic state to be able to provide relief for several days at a time. Is that right? That's correct what?
Speaker 2:is it about the ear? For several days at a time. Is that right? That's correct. What is it about the ear? Well, the cranial nerve sites that are found on the helix, the contra and the tragus side of the ear stimulate 5, 7, 9, and 10 cranial nerves, majority of the vagus nerves. And how we know that is because the response when we put the device on right I mean you've seen the device in action and it's incredible. So it really you'll see that the decrease in blood pressure, decrease in pulse, the individuals are able to have a conversation and really understand what's going on with them. So it's really calming that autonomic nervous system, being able to have the restless leg, the pain, all of those things. I mean it's really incredible the way that it works. I was so impressed with this when we were at AWARE that we actually did a study with Yale University on this and this research was published and we're doing more research now to see other substances that it addresses but it's cleared by the FDA to use on opiate withdrawal.
Speaker 1:So my former life, before I did addiction medicine, I was an ER doc and to be an ER doc you have to know a little bit about everything, so we oversimplify everything. So let me see if I can make this make sense in my former ER doc brain. So opiate withdrawal is a state where the sympathetic fight or flight nervous system is in overdrive and the opposite of that would be the parasympathetic nervous system, the rest and digest nervous system. So we are trying to stimulate the vagus nerve to get the parasympathetic nervous system active to suppress the withdrawal.
Speaker 2:Is that right? That is spot on.
Speaker 1:Wow, okay, bravo. So I've used it on one of my patients. He had a very good experience with it, except one of the leads kept coming out. So talk to me about how your device and your specific technology, what the device looks like, how it's applied and how a clinician would know that it's working.
Speaker 2:Okay, the device is very small. The adhesive is placed on the soft tissue behind the ear and then the leads come around and there's a grounding wire that goes on the lobe of the ear. So jewelry has to come out of the ear All jewelry does and then you have a point locator that finds the other three sites and it's placed on. Just like you said. Those leads are applied onto the external part of the ear and the leads can come out. We try to do a really good job of using the adhesive that we have, as well as other little tricks that we've learned over the years. Liquid adhesive is another good one to be able to keep those leads on. We try to instruct individuals with long hair so that they're not trying to pull their hair out, and we also mark where the leads go in the ear so that if they do come unlodged, we can have the patient or someone in their support system reapply them back onto the site. That seems to work really well.
Speaker 1:And the leads are basically a very tiny needle and that it basically punctures the skin and then, because it's metal, it conducts electricity. What does the, the device itself do? I mean, I, I saw it on the patient's neck, it's got batteries in it, right, and it's just electrical, electrical stimulation that goes through those wires and it pulses.
Speaker 2:And if you were to apply the device to your ear, to my ear, when and I have actually used it on myself for back pain and when I was traveling and you know, when you first get it applied to the ear, to my ear and I have actually used it on myself for back pain and when I was traveling and when you first get it applied to the ear you can almost feel a little bit of buzzing and you can hear that and you can feel tingling in those small little needles. Sometimes if you get it too directly right on the nerve it can be a little bit painful. So you want to move that, possibly if the patient is uncomfortable. But it stays on for that 120 hours or five days and it's an electrical stimulation from the battery in the device that stays on and it turns off after five days.
Speaker 1:Why five days?
Speaker 2:Well, that was the determination, from when we were doing the device, of how to get through that first 72 hours, the first three days, which are usually the most intense, and five days to be able to get the person cleared from their significant withdrawal symptoms.
Speaker 1:Was this device developed before fentanyl was the dominant drug? Yes, how has its use changed when we went from heroin to fentanyl?
Speaker 2:How it's changed and that's a great question is that sometimes patients will need two devices, and one of the things that we are looking at making upgrades to the device because, as we know, addiction medicine the beast gets bigger right the illicit drugs get stronger and stronger because the response we want to have they want more of a high. So if individuals get accustomed to that, here comes fentanyl and then we have a larger dose of fentanyl. I'm hearing from providers now and I've experienced this myself that the Suboxone that we provide just really isn't answering the fentanyl withdrawal. I mean, you see that right, and so individuals are coming off of that using on top of that medication. So what we're seeing is that we're looking just to have a 10-day device that stays active for 10 days to be able to answer that.
Speaker 2:What we're teaching and instructing providers now and even patients, is to do their best to have a higher CAL score, meaning a higher withdrawal symptoms, to be able to start the device so that you don't have to use two devices. We want to be able to respond to the need without increasing the cost. That's not our wish. We want to be able to address this and be able to get people to get better and to be able to answer that. So we are looking to create a 10-day device because of that very thing.
Speaker 1:If people put the device on before their last dose of opioid, does it prevent withdrawal?
Speaker 2:did a study and she actually placed the device on when people were still actively using and she was able to prevent the withdrawal and prevent precipitated withdrawal and started her patients on long-acting Brixati and that's an incredibly interesting study.
Speaker 2:Yeah, exactly, and this was patients that were very vulnerable and so they, you know, very difficult coming back. We see that a lot, right, you know, patients that are homeless or are having housing issues, etc. So she got very creative with this population as she was giving them this long-acting injectable, which actually saved many of her patients' lives and kept them coming back.
Speaker 2:That's genius, right, that is genius vice you can prevent precipitated withdrawal, which I love as well so I do all outpatient in my practice so you get the device on and you can start the patient sooner than you would. You know a lot of patients are not able to wait that period of time because of that precipitated withdrawal that we see and they're so fearful of it. I've had so many patients that have been placed in precipitated withdrawal and they end up in the emergency room and they have to go out and use, et cetera. So this gives them the opportunity to be able to prevent that and she saw incredible results from that.
Speaker 1:So let me ask you a couple of clinical scenarios. So a person is using fentanyl and they want to stop. As they go into the withdrawal, you put the device on. How long do you wait before you dose the Suboxone?
Speaker 2:It's going to really depend on the patient, right, I'm going to let them pretty much lead the treatment, and this is another reason I really like the device. So a lot of times in addiction, in early recovery, you have a lot of people making a lot of decisions for the patient, right, telling them what to do, when to go, what to do. None of us like that, you know. None of us enjoy that, but especially someone who has a trauma response, that has trauma in their life, which is a large portion of our patients with substance use disorder, and so that control is very important. Also in experience of seeing this and working in this field, also in experience of seeing this and working in this field, patients that direct or guide their treatment have a better long-term outcome.
Speaker 2:I see that when they're saying you know, I want to do this, I don't want to go inpatient, I want to do this, and sometimes it's not the right decision. But if they're directing and they're saying, okay, I want to do this, it's a great trusting relationship and that's important as providers to build a trust with that patient. So when the patient is saying I'll put the device on, I will work with them, I'll say let's go as long as we possibly can, until you can't stand it. And they're okay, I got it. And they can call at three o'clock in the afternoon or 10 o'clock at night and say I'm going to use and if okay, let me just call you in something, let me get you on a Valium for the night, let me put something in your system to get you through until I could see you tomorrow morning.
Speaker 1:Get them through as long as possible before you can put the device on. So I'm currently telling my patients and I don't know where three days came from, but that seems to be the prevailing wisdom with my colleagues here on the central coast of California that from fentanyl to suboxone, three days waiting is pretty good to avoid precipitated withdrawal. Can you shorten that when the ST Genesis is running?
Speaker 2:Absolutely, and that's the thing that we want to do. Three days is. You know, if somebody was to tell me, don't eat sugar for the next three days or don't drink coffee for three days, no problem, I got you. Three days without using an opiate. If you're an active withdrawal is like 30 days without a glass of water. I mean, it's nearly impossible. I don't even want to say that I understand it. I've never been through it, so I certainly don't want to.
Speaker 2:But I've seen enough patients and have enough respect for withdrawal symptoms to be able to say that's an impossible ask. A lot of times, and what we've also seen when we ask individuals to wait that long, they may do 48 hours, and then 48 hours that next night they're going out and they're buying an illicit substance and we're putting their life on the line and so it's really very dangerous for our patients and for their families, et cetera. So being able to shorten that window by 48 hours if they wait 24 hours to put the device on and you can start them on a protective medication, you're saving that individual's life.
Speaker 1:Well said. Do people ever use the device to just get through opiate withdrawal completely and then get on naltrexone?
Speaker 2:They do, they do and again I look at the lethality of what they're using, how much they're using, what route they're using, etc. And then also their history. They have an overdose history, you know. Have they attempted to take their life, etc. Things like that and I will do my best to educate them on the best medication regime for them. Again, this is going to be their recovery and I want them to make those decisions and they have done that and I've done that. Actually, I've gone from Suboxone onto Naltrexone.
Speaker 2:I have had patients that have gone from fentanyl use onto Naltrexone and they've done well and I've been able to do that. And that can be a delicate dance as well. As you know. The device can also be used at, let's say, that you're at the end of treatment with a patient. I've had patients that have been on Suboxone for eight, nine years and they want to come off of it. And I had a woman that she was actually going abroad to study and she had been on Suboxone for nine years and she wasn't going to be able to get it where she was going. So we worked with her for three months, got her down in her does and we used the device to get her off completely before she traveled.
Speaker 1:Yeah, I have the same experience as you do, that it's very hard to get on naltrexone because you have to get all the way off of opioids to get on naltrexone. I only have one patient on naltrexone for opioid use disorder because nobody can take the withdrawal. Most of them go to methadone or suboxone. That is a very interesting idea. Fentanyl to naltrexone. I don't think I would have believed that if you had told me, but of course I wasn't factoring in using the Genesis device.
Speaker 2:I wouldn't have believed it either. I wouldn't have believed the things that I am saying if I hadn't have seen this over 300 and something times that I've used the device and our nurse that has applied it. It's just been. It's blown me away to see the patient's response and how well they do when using the device and how they have long-term recovery. I got a text yesterday from a mother and she's incredible, but her son. We used the device on him nine months ago and he just celebrated nine months of his recovery and he's on Suboxone. He's doing very well. We used the device on him and she is just such a fan. You know she's just like nothing else has worked for this young man because he was able to not have the significant, severe withdrawal symptoms that he's experienced for his whole entire life of using and that's been about 15 years. He's almost 40 years old and he's doing very well. He's got a job. He's still living with his parents, but he's doing great.
Speaker 1:So thinking again back to how this device works, right, withdrawal is the sympathetic fight or flight state and we are turning on the parasympathetic rest and digest state. Wouldn't that mean it would work for other withdrawal syndromes besides just opioids?
Speaker 2:That is exactly what we are doing research on right now. So we have a very large treatment center that we are working with and we are testing this with alcohol, benzodiazepines and amphetamines. I have used it off-label in my own practice for those, as well as for cannabis withdrawal. Used it off-label in my own practice for those, as well as for cannabis withdrawal. Where we are, we have a pretty significant problem with individuals using cannabis and coming off of it and there's not a lot of resources. Detox doesn't even really accept that. So, using this device, I've used it successfully with alcohol.
Speaker 2:I have never had a patient that was solely on benzodiazepines as an abuse drug to be able to use it on. I have. I mean, obviously I've detoxed patients on benzos, using benzos on a taper schedule, right, but the device I haven't had the opportunity to do that. I think that's a rarer animal, it's an individual that are just using benzodiazepines. I know they exist, but I haven't run across that personally. Alcohol incredibly successful, incredibly successful using it. But, as I said, it's FDA cleared for opiate withdrawal, so it would be off-label and, of course, as a provider, you could use things off-label. But we are actually applying for it to get approved for more devices Because, as you said, it's that reward pathway. It's the same thing, it's going to work, but I've seen it work incredibly well with alcohol same thing.
Speaker 1:It's going to work. But I've seen it work incredibly well with alcohol. Okay, so same question Since the device turns off that sympathetic fight or flight response and turns up the parasympathetic rest and digest response, can it work for PTSD?
Speaker 2:I have not tried it for PTSD. I'm going to say that it absolutely will work with that because I think majority of our patients with substance use disorder experience PTSD. Right, I mean active use itself is traumatic. You listen to our patient's stories. I had a patient not too long ago. He was incarcerated for 32 years. 32 years of this man's life he spent incarcerated and you know the story that he has told was just chilling right, of what his experience was. So he didn't even realize that he has PTSD. But any individual that lives their life and they spend enough time using substances alcohol, drugs, whatever it is they're going to have trauma, right. And so I absolutely believe that it would work with PTSD.
Speaker 1:I will tell you that I have PTSD from my 14 years as an ER doc, yeah, and I actually chatted with my therapist yesterday about triggering, and it's really weird. I will be totally fine, and then, all of a sudden, I am in fight or flight mode, and my patients tell me a very similar story. I guess the only question with the device, though, is could you use it continuously for more than 10 days? If it helped with PTSD triggering? Are there any major side effects?
Speaker 2:No side effects that we know of At this point, though the battery lasts for five days, so it wouldn't have that electrical stimulation for a long period of time. The other thing that you just mentioned about you don't know when it's going to occur, so if it's something that is more triggered instead of continuous, we'd have to put it on when it's happening. I was in the ER for many years myself. I understand that. I think many of us in healthcare I mean, you're going to have vicarious trauma, even if you don't have trauma yourself. But when you see someone walk into your ER with an ax in their head or a child, if you've done CPR, which we have on children, and we've got the stories. My son-in-law is a state trooper. He has PTSD. So many different areas of individuals that could benefit from this. I also think that there are some neuromodulation that occurs when using the device, so I think there's an area that we could look at that it maybe helps long-term with also pain and with PTSD.
Speaker 1:And again we're getting a little off topic here, but I was just imagining being able to reach back behind your ear and turn it on when triggered, Right yeah, and I'm fascinated to hear that this also works for alcohol withdrawal. Given the mechanism of action of the technology, it makes perfect sense.
Speaker 2:It's incredible, it really is, and I got so excited using the device and so interested in seeing what other things that it worked for. I'll tell you the first patient that we used it on was a 26-year-old male it was the height of COVID right when it happened and it was a young man. He was in Connecticut and he was in his home and no one was taking patients inpatient. Everyone was kind of stopped in time and this young man was using methamphetamines, fentanyl and he was using cannabis and we had a nurse go out and we placed the device on this young man. He had been in 16 treatment centers. I did not feel like this was going to go well at all. He was combative, the home was in disarray, his parents were just beside themselves, he had attempted suicide A very significant case, really significant and if it had not been COVID, I would not have chose this as the first patient that I used this device on, but we did and he had a Cal score of 24.
Speaker 1:Wow.
Speaker 2:When we put him in. I mean it was significant Diaphoretic, he was tachycardic, I mean everything that you can think of, just extremely volatile. And we placed the device on and in 20 minutes he went outside to smoke a cigarette with his father. The nurse had got me on a Zoom call and I was on Zoom watching this scene and I was thinking we're fixing to go to the emergency room. That's why I was just about to say call an ambulance and he came back in from smoking a cigarette and he had a cow score of six. I said did he use something there's? I just can't believe this, but it was the device. It was the device. So he ended up doing incredibly well.
Speaker 2:At day three, I was checking in with this young man for three days. That night, after we placed the device, he sat down and had dinner with his family. His mother called us and said my son is sitting down eating dinner with us. I couldn't believe it. He had zero medications on board. Now, day two, we did start him on clonidine and gabapentin. To be completely transparent, he was having significant restless leg and he was still feeling anxious. So we did put him on clonidine. We did start him on gabapentin and I think might have put him on Bentol, but he did very, very well without any other medication and he ended up going on Suboxone after four days and he did great after four days and he did great.
Speaker 1:I wonder if some of his impulsivity was PTSD and the device, in addition to treating his withdrawal, suppressed some of his triggering, which is what allowed him to sit down and eat dinner.
Speaker 2:He did have significant PTSD. His opiate addiction started because he was a lacrosse player and he had a significant injury. His entire future was just erased because of his injury. So he lost his scholarship, he lost his future with that and then he started this heavy opioid addiction. He was prescribed Percocet for a year. A year-long Percocet is a prescription, so after that, you know, he lost everything. He was still living at home, he did not find a job, he did not find a future and so he had significant, significant trauma. So absolutely I don't think that that's outrageous to think of.
Speaker 2:As I said before, the patient being able to have a voice and not have everybody else making decisions for them is that if either any of us were in the amount of pain and significant withdrawal symptoms that our patients are in, we would say yes to anything. Yes, yes, yes, just get me off of this. So I think our patients and what I see is that they say yes to things that they don't really know what that means long term. So the young lady that I was talking about, that was going abroad to study, she explained like her situation. She said I said yes to Suboxone.
Speaker 2:I didn't even know what that meant. I didn't know that I was going to have to come in the provider that she was going to. She had to come in every week for the first two months and then do groups and these different things. She didn't really know what she was saying yes to. I think that happens quite often with our patients. They say yes to these things to get them out of that moment and then they're not really sure what they've signed up for.
Speaker 1:I would agree with that.
Speaker 2:And it may be a life-saving event at that moment. But again, I think, to have long-term recovery and long-term the patient is saying yes to it's just like informed consent we need to be able to really explain. What does this mean if we're going to start you on methadone? What does it mean if you're going to go on Vivitrol, just any medication that we prescribe With SSRIs? We have to do a lot of education, teaching, black box warning, things like that but a lot of times with other medications we don't do as much education what that's going to mean for their life.
Speaker 1:So the patient that I used it on was a gentleman that had been on methadone for pain and unfortunately there was an issue with his methadone prescription and he couldn't get it and went into horrible withdrawal, didn't know what to do.
Speaker 1:So a friend said he had some oxycodone, which of course wasn't oxycodone, it was fentanyl. And so he just was using fentanyl and came to his next appointment and got a methadone refill and didn't think to say anything because he thought it was oxycodone. And then on his urine drug test he was positive for fentanyl and he was in withdrawal on methadone at his old dose because the fentanyl had brought his tolerance and dependence up on him. And he came into the office and we did a Zoom call with one of your nurses. She was wonderful, helped me put the device on and in an instant he noticed a difference. It came on very quickly and the only issue for him was I couldn't get one of the leads to stay in place. And that's probably you know me, never having done this before. What are you working on in terms of innovating the device? Could you change the technology so it sticks better, or does it have to be electrodes? We're always looking to innovate as humans. What are you looking to innovate with the ST Genesis?
Speaker 2:Yeah, great question and we are looking at several different things and we are working on implementation, the 10-day, like I said, the other thing is making it waterproof because people want to shower and they want to work out or et cetera. It doesn't really become an issue. You know, we tell people they could put a shower cap on it or how to not get it soaking wet, and then the leads, the wires that come around. We want them to be less invasive, some technology around that so it doesn't have that capability of pulling those leads out and better adhesive if those things can't happen.
Speaker 2:As I said, rosemary is who the nurse I think was working with you. She's phenomenal and you know that's the other thing when you have somebody that understands the technology and also gets so into it. I can nerd out on this stuff so much because it's so fascinating to me and I love being able to offer patients these innovations and these new ways to be able to treat their symptoms. But that can be something that if one of the leads comes out again they're going to have a return of symptoms, and we don't want that.
Speaker 1:Yeah, the gentleman is now back on methadone and doing great. My experience was that he came in, we put it on and literally as soon as I turned it on, he felt something and for him, a couple of unique issues. He had hearing aids, so we obviously took those out. Rosemary was exactly the nurse I worked with. She was awesome, and what I ended up doing is he was doing great in the office and when he went to sleep is when the lead came out. So he came back to see me the next day and then I tried to reinforce it and then he went to sleep again and dislodged it again the next day. Is there a way that you tell people to sleep to avoid the device getting dislodged?
Speaker 2:We do. You know a lot of times if we can put, like I said, the liquid adhesive that works really well to be able to keep it on. I know when we have had that problem or individuals that have pulled it loose or it comes loose during their sleep. If we mark that site then they can push that right back on. And so it just depends on where the site, where you find it.
Speaker 2:The ear can be very tricky right to be able to keep anything on. It's not a smooth surface, there's no fat tissue there, it's a very cartil. Anything on it's not a smooth surface, there's no fat tissue there, it's a very cartilagy. It's a very awkward place. So those small little needles, if you get it right in the right place, putting that liquid adhesive on to be able to keep it on, is the best way to do it During the night. If we can have them lie on the right side instead of on the left side, if they can avoid it right, if they're sleeping so soundly they move over, that means the device is working great. So I'm actually happy that they're saying I didn't even know what I was doing. So if they're sleeping, that means the device is working great.
Speaker 1:I was going to ask and I believe this is true, but I have not actually fact-checked this. I remember hearing that everyone's ear shape is unique, like their fingerprint. Are there certain ear shapes that this device it's easier to use or harder to use.
Speaker 2:I don't know if it's necessarily ear shape, maybe. So I mean, a very small ear is more difficult, just like anything else. You don't have as much landscape right, so that it's difficult to do Individuals that are much older adults the skin is sagging. It's a little bit more difficult to adhere If they have a lot of piercings in their ear. That also can be difficult because they may have moved things around quite significantly.
Speaker 2:You know, I think that it's really more about making sure that the person places it in the correct way and with enough adhesive, and finding the right sites, and that's something that we do a really good job of. And, as you've had experience having individuals that are really knowledgeable about the ear, I've never learned so much about one part of the body in my life, right so much about the ear and, like you said, it is like a fingerprint. I didn't realize either that every single person is different. It's unique to them and as we age, things in our body move and shift. So where my tragus site was five years ago, it's probably in a different location five years later. What if someone has?
Speaker 1:cauliflower ear.
Speaker 2:You would want to use the other ear if they have that. So any deformity in the ear. You would want to use the opposite ear if they have that. We like to use the left ear, but we can use the right.
Speaker 1:According to WikiHow, we all have different ear shapes. That's not peer-reviewed, but that's what I found on Google in the last 10 seconds.
Speaker 2:Well, I can send you some journal articles that speak to that and as well as some criminal investigations where they have actually used the person's ear for criminal things like that, to be able to identify the person. So it's interesting and again, I am not an expert. I want to clarify that I've never taken ear imprints. I don't know, but I do know by using this device as often as I have. It's very unique. Everyone's ear looks very different.
Speaker 1:What other devices does your company make?
Speaker 2:This is it. The ST Genesis is the only device that we have. We are a pharmaceutical company as well and have some pharmaceutical medications, but they're not related to substance use, and I'm overseeing only the ST Genesis and Speranza.
Speaker 1:How did you get interested in addiction medicine?
Speaker 2:I saw many of our patients that came in with substance use disorder complications and it became very dear to me just because I saw many of those individuals being not treated very well, especially in the emergency department.
Speaker 2:And this isn't to say that it was anyone's fault, necessarily, but a lot of times in the emergency room we are very, very busy. We're working on very serious critical emergencies, life-threatening emergencies, and so individuals that come in with substance use disorder that are not in that life-threatening situation, we're put in the hall, put in different places, and I just felt a big soft spot for them and I thought I want to make a difference. And when I went back to school I found a niche that I felt very good about. I really enjoyed it. I enjoy the population, I understand the disease very, very well and I'm able to really connect with my patients on a level that I'm not sure that a lot of people really enjoy it. I really do, I really enjoy it. I love seeing people get better. I love seeing people's lives completely change, and you don't get to see that in other areas of medicine.
Speaker 1:Lives completely change and you don't get to see that. In other areas of medicine. I've had a very similar experience to yours, that I got tired of having people come into the emergency department and not knowing what to do and not knowing how to help Right.
Speaker 1:So, I've had the same experience as yours that getting to be an expert in the field of addiction has been really enjoyable and patients are really grateful when they are treated with respect. The patient that I put it on myself felt like a VIP, that he got to try this device out and he was very grateful. And again we finally got him back on his methadone and his tolerance came down and, yeah, how does it work with insurance?
Speaker 2:Well, we're working with several insurance companies. Private insurance does have a reimbursement. We would like to and we're working towards getting Medicaid to be able to reimburse the device. That is the majority of our patients and I absolutely know because of the work that I do and pro bono, I'll work with patients that don't have funds to be able to do this, to be able to place the device. I know what a difference it makes in their life. I know what a difference it would make in the emergency room if we had this device.
Speaker 2:Imagine all your patients that come into the emergency room that you give Narcan that leave AMA Massive number of individuals If you were to place this device on them, prevent precipitated withdrawal and be able to give them an injection before they leave. It would just be a game changer for so many individuals and also save time, save our staff burden. We have so much burden on staff nurses, physicians, dos, nurse practitioners that are wanting to be able to address the problem but can't because of time and shortage. This would be able to answer so many of those problems. Emts out in the field to be able to use this after they if they Narcan individuals, because we know it gives the individuals their right into precipitated withdrawal. They don't want to stay, they want to go back out and use and they want relief of their symptoms.
Speaker 1:Yeah, I was just thinking and I realize nothing in health care in America is, unfortunately ideal. But I really think the ideal case for what you've described is for patients with opioid addiction is placing a device like this that suppresses withdrawal and then immediately starting a long-acting injectable buprenorphine product. What's really ironic is here in California our Medicaid is called Medi-Cal. Medi-cal covers the long-acting injectable buprenorphine products. No issue, right, and the commercial insurances are a disaster. So actually I'm thinking of one of my patients right now who his insurance denied his long-acting injectable buprenorphine. I'm going to send him information about this to see if he'd be interested, because he does have commercial insurance. So the one-two punch would be is if we could make it easy to start a patient on Nerve Field Stimulation in the ear and then put them on long-acting injectable buprenorphine.
Speaker 2:Absolutely. I've written a protocol for it. It's something that just is a very no-brainer to me, absolutely. And you're talking about a large portion of our population that again have difficulty with transportation, with housing, getting to appointments. If they have the long action injectable on board, they have an easier time and a larger window than if they were to have an oral Suboxone or tablets, right? So it's really important that we look at how can we save and help this larger portion of the population that are really in need. This is to me, like you said, it's a no-brainer. But it doesn't always seem to be a no-brainer in health care sometimes.
Speaker 1:I was going to try to make a pun and say it's a no-earer, but that didn't seem to follow.
Speaker 2:We can laugh about it.
Speaker 1:Yeah, I'm sure wherever my daughter is right now she's rolling her eyes at my bad dad humor. I tell my daughter once you have a kid, your humor just falls apart.
Speaker 2:All you do is dad jokes. It's horrible. Well, it's because everything is funny to you and then I just became a grandmother. That's even funnier when you get to see your child raising their kids. You're like oh, I'll remember that.
Speaker 1:Well, I think we've covered about all of my questions. I am so excited to start giving patients information about this and I think the issue for me is most of my patients have Medicaid. I have a handful who have opioid addiction and private insurance. So I'm thinking of one gentleman. I'm going to send him information about your product later today. Well, regrettably we are at my time stop because I have to go get my daughter from Taekwondo camp. Anything you'd like to leave us with as we wrap up?
Speaker 2:Yeah, if you're interested, you know, visit us at spronzotherapeuticscom. There is a hotline there that we can answer any questions. We are always looking for providers to get trained. I just actually contacted you last week about a patient that called our hotline. One thing that you know I would really love is to be able to train as many physicians, addiction medicine providers as we possibly can. Nurse practitioners across the country. We have many, but we need many more. So we're always looking to train. It's free, it doesn't cost anything. We're a great team, as you've had the experience really enjoyable working with our providers. We partner really more than just try to sell a product. We really want patients to do well and to be able to expand your practice. So if you're interested, visit us at espranzatherapeuticcom or give us a call and we'll talk to you about more how to get trained.
Speaker 1:Well, I have to say, I've learned a ton and, as I like to say to my podcast guests, I will be a smarter doctor next week. So thank you so much and I really appreciate your time. I'm just copied the link for your website to send to one of my patients later today.
Speaker 2:I appreciate it so much, dr Grover, and I really do appreciate you and your innovation and thank you for the kindness and dedication and compassion that you treat our patients with. It's really, really inspiring.
Speaker 1:Before we wrap up, a huge thank you to the Montage Health Foundation for backing my mission to create fun, engaging education on addiction, and a shout out to the nonprofit Central Coast Overdose Prevention for teaming up with me on this podcast. Our partnership helps me get the word out about how to treat addiction and prevent overdoses. Word out about how to treat addiction and prevent overdoses To those healthcare providers out there treating patients with addiction. You're doing life-saving work and thank you for what you do For everyone else tuning in. Thank you for taking the time to learn about addiction. It's a fight we cannot win without awareness and action. There's still so much we can do to improve how addiction is treated. Together we can make it happen. Thanks for listening and remember treating addiction saves lives.