4.2

Wearable Neurostimulation Clinical Trial Part 2

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4.2
Transcript

Daniel Litwin:

Hello everyone, and welcome to another episode of Vital Spark, a Spark Biomedical podcast. I'm your host Daniel Litwin, the voice of B2B. Folks, thanks so much for joining us on another episode of the show as we continue to explore major trends, treatments, technologies, and innovative methods for opioid withdrawal treatment and the larger healthcare industry.

So as we maneuver today's conversation, make sure that you're heading to our website, sparkbiomedical.com. Again, that's sparkbiomedical.com for previous episodes of the podcast, as well as other pieces of content, including videos, articles, blogs, and more. You can also subscribe to the podcast on Apple Podcasts and Spotify.

So today's episode of the show is actually part two of two on Spark Biomedical's clinical trial that help validate the efficacy and the impact of opioid withdrawal tAN therapy. So if you missed part one, probably going to want to take a pause here, click out the page, go find episode one and give that a listen because we pick up right where we left off in the previous episode.

In that previous episode, we sat down with the principal investigator for Spark's adult opioid withdrawal study, Mr. Dr. Carlos Tirado with CARMAhealth. And Dr. Tirado helped unpack the vision behind the therapy method, its history of validation and how Spark approached putting together, running and compiling data from the clinical trial. And this second part, again, picks up where we left off in our conversion by highlighting one clinical trial participant's journey through tAN therapy and how this reflects the positive impacts that this therapy method can have for the entire withdrawal ecosystem by, again, rooting it in personal experience and personal impact. So let's go ahead and jump into part two of two of this conversation. We hope you enjoy.

All right, Dr. Tirado, thank you so much for that deep dive into the full study. What I want to do now is, kind of within the context of this study, highlight a case study of one patient. Her name is Eliza, and we're actually going to show some quick video clips from her case study, but if you want the full video, audience, you can find that on Spark's website. It's actually right on the homepage, if you scroll down.

But I want to highlight this case study from Eliza who made Sparrow a part of her withdrawal treatments. And I think this is really going to help ground the impact of Spark's approach and substantiate the study with some anecdotal examples. So I have a few clips from this case study video. I want to check out three of them that I think really speak to why validating this treatment method is so critical and the kind of impact it's having on patients struggling with an opioid addiction. So let's go ahead and play the first clip.

Eliza:

I've been through detoxes before I've been on the taper and I've experienced the pain that it still causes. And I experience this and it's completely different because you don't have to worry about waking up in the morning and waiting for your taper and getting sick and all this stuff. It's already making you feel better. It's already helping you physically and mentally was one of the things that I noticed, because I didn't feel foggy from all the taper meds. I just felt clear. And talking to the other people around here, I'm like, they don't feel like as clear as quickly as I felt clear, which was really interesting to me.

Daniel Litwin:

So I just found it particularly, I guess, poignant how she drew comparisons to other detox methods and how painful they can be and how quickly this detox method turned into actionable results for her.

So my question for you, Dr. Tirado, is how does a less disruptive detox, in general, how does that impact not only the patient, but also the entire ecosystem of treatment, right, the treatment staff, physicians and resources allocated? Give us your thoughts there.

Dr. Carlos Tirado:

Yeah. First, I really want to celebrate Eliza for putting herself out there. If we really think about what courage it takes to be self-disclosing, right, about your condition, I can't think of a more courageous step for a person to take. So I just want to make sure to recognize Eliza.

But yeah, I would say that some of the key things that Eliza mentioned, which we've touched on a bit during this talk, is the fact that, because this is a non-invasive, non-medical or non-pharmacologic approach, that you're not having to deal with the known adverse effects, right, of medications that are used to treat withdrawal, or you can reduce the amount of medications that you're having to use to treat withdrawal.

So in her case, when she said the taper, right, and it still causes pain, she's actually referring to a Suboxone taper, right? And I kind of touched on that earlier. That's an opioid substitution taper. And what she's saying there is that even with an opioid substitution taper, you still feel discomfort. Okay? So if you can imagine having to mitigate that opioid withdrawal even with or without opioid substitution, it's a great challenge. And not only that, but throughout the entire process, she was able to feel as she called it clear. What I interpret there is not over-sedated, not feeling sluggish or cognitively slowed. And the upside of that is that you can participate more fully in the treatment programming, individual and group therapy, the types of things that are happening when you're in a treatment program like that.

Daniel Litwin:

Yeah, absolutely. And I want to reiterate what you said about Eliza, too. I mean, it is truly courageous to be able to step up and be so vocal, but then also to be filmed and to be evangelizing a treatment method in the context of your own journey, through treatment is just, yeah, very admirable. So I appreciate you making note of that.

I want to highlight another clip here. This one kind of doubles down on the speed, but I want to just hear in her words how she described the speed of the treatment and then get your thoughts on that as well. So let's go ahead and roll that clip as well.

Eliza:

So I think what surprised me the most was how fast it worked, because I thought maybe this thing would work in two days or something. Maybe the first day, I was going to feel awful. And I remember even saying to people, I was like, "Oh, day two and three, that's the worst," but by day two, I wasn't even really thinking about my withdrawals. And so I think that's probably what surprised me the most. That's what surprised me the most was that it worked so fast.

Daniel Litwin:

So again, she was incredibly surprised by the speed, and she mentioned that in the first clip and, again, here in this second clip. And I think it really speaks to how effective the treatment is, but also, how quick the speed compares to other classic treatments and kind of the cycle of feeling better and that initial sense of relief, right? So how does the speed of treatment define its success in this space? Right? Is speed needed? Or I guess if we listen to what she was saying about previous methods, it doesn't sound like the speed of treatment was ever really a given in opioid withdrawal treatment. So give me your thoughts there. How does speed actually play into the ecosystem of opioid withdrawal treatment, and how important do you find speed to be in this space?

Dr. Carlos Tirado:

So Eliza pretty much said it all right there in that clip. She touched on the fact that she had a certain expectation of maybe kind of having to tough it out, especially during the first two to three days of the treatment, because what it did is that mirrored her experience in the past, right, when she's had to go to through withdrawal, or she's had to go through a taper that she had alluded to earlier. That was the expectation that you might get a little worse before you get better, and it is not fun. It's painful. It's unpleasant. So the fact that she was able to get, I wouldn't say immediate relief, but relief within that 60 to 120-minute window, really set her up, right, for a positive expectation and experience moving forward.

The frame of mind that an individual goes into a treatment like this with is very, very important. And if they're able to experience a relief kind of on a time scale that they're really not accustomed to, that really helps enlist them more positively in the treatment process, and then obviously, it allows us to be able to work with them effectively. She talked about not feeling drugged, feeling clear, a rapid onset of action. Those are all things that you want in a therapeutic, when you're treating people who are really subjectively quite miserable and, as I had mentioned earlier, at risk for just leaving, just voting with their feet and walking out of one of these places. So being able to engage relief on that time scale can be really critical for some patients in terms of predicting engagement and kind of working through that critical opioid withdrawal treatment stage.

Daniel Litwin:

Absolutely. And this isn't a clip I'm going to play just because we're running out of time here, but if you do watch the full case study on Spark's website, you'll actually hear Eliza say something very similar where she basically said, "When I was first approached with this treatment method and I went to the treatment facility, I basically said all I want is drugs to help me with the treatment. If you're not going to give me drugs, I'm going to leave." And she was just already not trusting of anything new and novel in this space. And so I imagine introducing something that seems so foreign compared to the typical detox method is going to need that speed and that immediate relief to also validate that it's useful to the patient and create that trust that it's worth building into the life cycle of treatment. So yeah, great point there.

I've got one more clip to show here from that case study with Eliza. Here, she kind of explains the overall impact of using tAN therapy and how this can create some opportunities for more treatment. So let's go ahead and roll that final clip.

Eliza:

When I first came in here, oh my gosh, I was so angry and I wanted to leave. I wanted to go home. I wanted to get high. I remember I told everyone, I said, "If I'm not getting meds, I'm leaving and I'm getting high, and I don't care what you have to say about it. I'm going. I don't care. I don't want to be here." And then after two or three days, because I was feeling so myself again, I don't know, it's so hard to explain because I literally... When I'm getting high, I've become a completely different person.

So the fact that it works so quickly and I didn't have to worry about taking more drugs to fix the drugs, sorry, I finally feel like myself again, and now, I'm going on to do more treatment, which was not the plan originally. The plan originally was just to come here, detox. And after a couple days of doing this and just talking to people and being myself again, I've made a huge decision to continue my treatment onto another place, which was like, my parents are just so grateful for, and I'm really grateful for.

Daniel Litwin:

So I kind of dropped the ball on that one actually. That clip does have the quote that I just mentioned to you earlier. I was confusing my clips a little bit. But yeah, as you can hear in her own words, she needed treatment to be immediately responsive and it was, and it built that trust. And I bring this up because she described the domino effect that comes from successful treatment that encourages more treatment and that actually builds a timeline of successful withdrawal treatment.

So I'm curious, do you find that domino effect of treatment important and do you find it to be particularly potent with successful tAN therapy? Yes, no, why or why not? And I guess how does that kind of factor into what defines successful withdrawal treatment therapy?

Dr. Carlos Tirado:

Yeah. Thanks for teeing that up. One of the things that I saw through the conduct of the trial and then the really powerful messages that Eliza had to convey was getting back to this notion that we have when we're working with people who have substance use disorders, which, if you believe the statistics, some one in three of us either suffer from a substance use disorder or are directly in contact in their lives with someone with a substance use disorder. So many stories to tell around this, but when a person is in the kind of the chaos that these disorders can bring, the need to help that person make what's, there's a common term in the recovery community, kind of the next right decision, right?

It is so critical because as she had alluded, or not alluded, she mentioned, she was on the precipice of either coming or going, right? She's either going to stick around. If things aren't working the way she needs them to, if she experiences too much discomfort, too much suffering, she's just as likely to leave and continue to use and engage in incredibly destructive and chaotic behavior.

So that's the tight rope that we often walk on with patients who are experiencing withdrawal and who have these really chaotic opioid use disorders and other substance use disorders. So the need to be able to relieve that suffering in a quick timeframe to, as she said, let her true self emerge. From a clinical standpoint, we're talking about an individual who is not racked with pain and suffering an anxiety from withdrawal, who is having overwhelming cravings for opioids that influences all of their decision-making, right? That true self is someone who's relieved of those symptoms, who can actually start making the next right decision. Okay?

So for me, the treatments that set people up for success, that help reduce those symptoms to allow them to get to their true selves, to make rational decisions, not decisions that are based on these overwhelming biological and psychological distress symptoms, is where we want to be during this particular phase of treatment.

I think she really highlights how much can change, even from one day to the next, in a person's overall outlook and disposition just by relieving those symptoms, right? Just by taking those off the table, she's able to make the next right decision, the next best decision for her health, align and ally with her family and treatment providers to try to get to a good outcome. So she really does such a great job of showing how the lived experience really influences her outlook.

Daniel Litwin:

Yeah, absolutely. And again, you can see how moved she is at the impact of this treatment. So more props to her for being vulnerable enough to share that kind of experience. And I think, again, it just further validates why this treatment method can be so impactful to solving this crisis of opioid addiction and broader addiction challenges here in the US.

So last main question I've got for you here, but now that the trial has been FDA-approved and we're seeing the use of this therapy, what comes next? Right? Is there further validation that has to happen to continue to push it as a treatment method? Are there any other trials coming up? And I don't know, are you hoping to build on top of the existing research in any way?

Dr. Carlos Tirado:

Yeah. Well, we want to do more research and we're actually doing more research. We recently received a NIDA grant, a National Institute on Drug Abuse grant to conduct a Sparrow trial as part of a non-opioid substitution withdrawal treatment protocol that is intended to transition people effectively to opioid blockade treatment, which I'd kind of touched on some of those treatment pathways earlier. So we have a funded trial for that that we're conducting in partnership with Betty Ford Hazeldon and Gaudenzia in Baltimore. And then the device itself is being utilized in the real world as well. We are incorporating it and reaching out not only to substance abuse treatment providers, but also to medical practices to hear the story of Sparrow, what it does in the context of the treatment of opioid withdrawal, and how clinicians, physicians, and other advanced practitioners can incorporate it into their practice for effective management of opioid withdrawal.

Daniel Litwin:

I think on that note, Dr. Tirado, we can wrap up our conversation here exploring this study. Again, thank you so much for your time. We definitely went long here and we explored all of the granular bits of the study and the science, but I think it was really needed to make sure our audience understands the rigor that went into the clinical trials and then how the validation of this therapy method is having tangible effects on the community of folks dealing with opioid addiction.

So thank you again for your perspective. Again, folks, we've been chatting with Mr. Dr. Carlos Tirado. He's chief medical officer and founder with CARMAhealth, and he was also the PI for Spark's adult opioid withdrawal study. He helped run the perspective, RCT, double-blind study. So again, Dr. Tirado, I really appreciate your insights today. And if folks want to get in touch, they want to pick your brain a little bit more on this and the future of tAN therapy for opioid withdrawal treatment, how can they get in touch?

Dr. Carlos Tirado:

Sure. You can... Daniel, thanks a lot. I really appreciate you hosting. You did a really wonderful job helping us get the message out there. You can feel free to email me. I'm at carlost, as in Tom, @carmahealth, C-A-R-M-A, health.com. Feel free to send me an email.

Daniel Litwin:

Perfect. Easy enough. All right, Dr. Tirado, thank you again for your time. It's really been a pleasure and I hope to pick your brain some more here in the future.

Dr. Carlos Tirado:

All right. Take care.

Daniel Litwin:

And thank you everyone for tuning in to this episode of Vital Spark, a Spark Biomedical podcast. We appreciate you all tapping into the full insights here on our clinical trial. For more information on this trial, you can head to our website, sparkbiomedical.com, and you can find plenty of other resources here validating not only the science, but the therapy method, and you can find more content, including Eliza's full case study on our site. You can also subscribe the podcast on Apple Podcasts and Spotify. Just look up Vital Spark, and it's sure to pop up. I'm your host, Daniel Litwin, the voice of B2B. Thanks again for joining us, and we'll see you on the next episode of Vital Spark.

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