Good morning, everyone. I'm going to get started. Thank you all for being here bright and early. We're really, really pleased to be here joining you today at APA. It is my pleasure to introduce this year's American Academy of Addiction Psychiatry Presidential Symposium titled Technology-Assisted Treatment Interventions for Substance Use Disorders. My name is Larissa Mooney. I am a professor of clinical psychiatry at UCLA and the current president of the American Academy of Addiction Psychiatry. I will be introducing our three wonderful speakers today and moderating the discussion and Q&A at the end. Because this is only a 90-minute session for a symposium, we're asking that everyone save your questions for the end so that we can answer them as a full panel. Today, Allison Lynn, Amy Campbell, and Don Sugarman will present on a range of telehealth-based substance use disorder treatments and describe their potential to augment existing evidence-based behavioral and pharmacological treatment interventions. They will also describe disparities and barriers to access to these treatments. And just to define our terms today, telehealth is a broad term that encompasses a variety of technology-delivered health services, including telemedicine, but also including digital health, such as app-based and app-delivered services. So without further delay, I will introduce our first speaker. Dr. Allison Lynn is an addiction psychiatrist and associate professor in the Department of Psychiatry, as well as research scientist at the VA Ann Arbor Health Care System. Dr. Lynn directs the University of Michigan Addiction Psychiatry Fellowship Program and is the president of the Michigan Society of Addiction Medicine and chairs the American Academy of Addiction Psychiatry Research Committee. Her research focuses on identifying actionable contributors, gaps and disparities in access, and quality of addiction care using large healthcare data sets, and developing and testing new interventions and models of care, including through use of telehealth, to improve reach and delivery of evidence-based care to patients. Welcome, Dr. Lynn. Thank you for that introduction, Dr. Mooney, and thanks to everyone here for joining us today. It's always great to be in a room full of mental health folks who are also particularly interested in addiction. And as Dr. Mooney mentioned, my work really focuses on both improving access to care, as well as outcomes and quality of care for patients with substance use disorders. And today I'll be focusing on telehealth for opioid use disorder care, presenting some of the recent research on what care has looked like for our patients during the COVID-19 pandemic, but also what that means for what care should look like in the future. These are my disclosures and acknowledgments. I want to emphasize some of the funders in support who supported the work that I'm presenting here today, including NIDA, NCCIH, the VA, and CDC. So a number of folks here have probably seen this figure or a very similar figure, but it's still a really important one to emphasize because I really think it provides the context for why addiction is particularly important for us to focus on, including across mental health professionals. What this figure shows is the mortality rates over time. It's a figure that's released by the CDC. It's important to also emphasize how things have evolved and will continue to evolve over the years. We know that over 20 years ago, this was a story of folks overusing prescription opioids and also overdosing on it. But for the last 10 or 15 years, it's really evolved to be one of street drugs, not just of opioids, but also really all substances. And so this brings us to what a lot of us now call the fourth wave of the overdose epidemic, which really focuses not only on opioids, but also on other substances, in particular stimulants, both cocaine, crack, and methamphetamine, as well as alcohol. So really patients who are using multiple substances or more than one substance. What this means to me, though, is that we have really now exposed a much larger swath of the American population to overdose risk and substance use disorders. And what it also means is that the typical patients that we're working with today not only have one substance use disorder, but really multiple and multiple mental health conditions at the same time. And the question is, how do we think of new strategies to really engage these very complex patient populations? And the most important thing, on the other hand, is to emphasize that we have effective treatments. In fact, highly effective treatments. These are, in particular, the medications for opioid use disorder treatment, so specifically methadone and buprenorphine to the largest extent, but also extended-release naltrexone. We have dozens of studies, meta-analyses, systematic reviews, cohort studies, that have really shown that these medications not only reduce substance use, but also substantially decrease mortality. And as a psychiatrist, I would say that these are probably some of the most effective treatments that I can provide to my patients. In addition to these medications, however, we also have other highly effective medication treatments and psychotherapy treatments for other substance use disorders. But the biggest challenge we have is really getting these treatments to our patients and also engaging our patients in the care that we deliver. And this is really kind of the biggest challenge that we face today because our best estimates show that only about a third of patients, sometimes less, are actually receiving these highly effective treatments that might save their lives. And it's not just important to get access to these treatments, it's really important to get ongoing accessibility to care. Because we know that for these treatments, especially the medications for opioid use disorder, they only work when patients are taking them. And in fact, when patients stop them, oftentimes their overdose risk really increases. So we really have to help patients not only start these medications, but stay on them long term, often over years. And so I'm a very practical, straightforward person, and I think about these questions kind of in pretty straightforward terms. In my mind, the question is, well, what's really contributing to these major treatment gaps? And for me, I think about it in three buckets. The three buckets really focus on, one, stigma. Second is the underlying symptoms of addiction. And third is really how our health care systems are set up and the barriers they sometimes serve in terms of providing care for patients. So stigma remains a tremendous barrier for our patients, but not only for our patients but also within our health care systems, across clinicians. I think this is an area that we've been talking about more so over the last ten years and recognizing all the impacts that it plays out for patients. So that ultimately, a lot of our patients wait 5, 10, 15 years to come and see us. Can you imagine if we could actually shorten that, even by a few years, how much we can really help patients gain in terms of their function, in terms of being able to participate in their families' lives? The other factor, I would say, is actually probably the least emphasized one and sometimes plays the biggest role. And that's really that we are thinking about the unique contributors of treatment barriers for this particular patient population with substance use disorders. Substance use disorder or addiction is by definition a chronic medical illness where someone is going to have ambivalence or have wavering feelings about making a change despite the negative consequences it causes. That is the definition of the illness. What that means to me is that we should understand and accept the fact that patients will have a hard time reaching out for help or for care. What that also suggests is that we actually have to make treatment a lot more accessible, more appealing for patients with substance use disorders. And so the thing that I always say is like, what if our addiction treatment clinics look like our cancer centers? I mean, oftentimes people will smile and laugh thinking like, oh, that would never happen. But why can't it happen? And that's what we have to be thinking about. Because in many ways, this is the population that really needs the most accessible treatment options we can have. And that brings me to the last factor, which is the ways that we deliver care for this patient population. And this is really what I'm going to be focusing on the rest of our time today. Just a note, factors across all of these categories have been expressed by people with substance use disorders as major barriers for them in terms of receiving care. One thing I really want to emphasize is really the very large impact that distance to care plays for this particular patient population. So this figure is a figure that shows all of the counties in the United States, mostly in gray, as you see. And in gray are all the counties with not a single addiction psychiatrist. You know, I think a lot of us would look at this and say, oh, my goodness. Like, obviously there's a huge room to grow. We certainly need more addiction psychiatrists. In fact, anybody in the audience who's a trainee, please come back up and talk to me after this because we need more folks like you. But we can't just rely on there being more addiction psychiatrists, right? We also obviously have other clinician partners, including other addiction medicine physicians and such. But what we really need to think about, because our patients are actually located in all of the gray areas, which is the vast majority of this country, and how do we actually get care to patients where they are, and how do we redistribute some of the expertise that we have, which these days primarily concentrated in large urban centers and very little outside of those particular centers. In prior research studies, distance to care has been described as a major factor for why patients don't follow up on our referrals and for also why patients discontinue treatment. This is unsurprising because a lot of the treatments we deliver require weekly patient visits, monthly patient visits over a long time, and you can really imagine how distance really exacerbates that challenge. And so for all of these reasons, this is why there's been a small group of us who've been really thinking about telehealth long before the COVID-19 pandemic. I think a lot of the discussion prior to the pandemic focused on rural patients or patients who really had major access challenges, but I think what I'm going to be demonstrating soon is that it's really applying to all of our patients, no matter where they live. And so first I want to kind of describe what we know in terms of the evidence or effectiveness for telehealth for substance use disorders, and OUD in particular. We know at this point there's probably been many dozen studies supporting the use of telehealth for all other mental health conditions. In fact, most of the telehealth literature really originated in mental health conditions including depression, PTSD, et cetera, really supporting that telehealth-delivered care is no less effective than in-person treatment applying to both medications as well as psychotherapy. However, there's far fewer studies in the area of addiction, and this motivated myself and colleagues to conduct a systematic review that was published in 2019. We took a very broad inclusion criteria to this because we knew there were very few studies. We included not only randomized controlled trials, but single-arm studies, retrospective cohort studies, and also some pilot studies because there were so few. And what we found was that in total in the literature pre-pandemic there were only five studies that examined telehealth for opioid use disorder treatment, and only 13 studies for all other SUDs, really only other SUDs including alcohol and nicotine. And for opioid use disorder there were no fully-powered randomized controlled trials. There were really a dearth of studies focusing on medication treatments, and most of those studies were retrospective studies. Despite this, though, we found that there were some indicators of comparable therapeutic alliance, meaning patients and clinicians felt similarly well-connected compared to in-person visits, and there was also similar retention in care, in some cases even better retention, for those who had received telehealth-delivered OUD treatment. So, of course, that was pre-pandemic, and then came the pandemic now over three years ago, and that really changed everything. So early on in the pandemic I think a lot of us here know that there were quite a number of policy changes implemented at the federal and state levels across a number of different bodies, including the DEA, SAMHSA, et cetera, that really decreased barriers to telehealth. And I think we really actually owe some credit to folks to have instituted these changes so rapidly, because nothing moves very quickly in health care, and this is probably the fastest change we ever saw. Myself and colleagues very early on had documented or summarized some of these policy changes in a viewpoint published in JAMA Psychiatry. The key things I really want to emphasize are, one, the Ryan Haight Online Pharmacy Act exemption. So this was not a policy change, but this was a written exemption into the Ryan Haight Online Pharmacy Act that has been around for well over a decade. And what it means is that patients who are going to be receiving controlled medication via telehealth do not have to have an initial in-person visit. I'll later or very soon actually get to what are the current challenges we're facing with this, but this was a really major thing that didn't require an additional piece of legislation to make happen, at least when we were experiencing a PHE. In addition to that, though, there were other many key changes. So in particular, use of phone visits that none of us would have ever expected possible for treatment before the pandemic. Also, flexibilities in terms of take-home methadone doses. Loosening of CFR 42 Part 2 confidentiality requirements. HIPAA flexibilities allowing us to use pretty much all platforms that's also being rolled back. Licensing regulation flexibility, so allowing providers to see patients across state lines. And of course, very importantly, reimbursement. So prior to the pandemic, almost no telehealth visits to patients at home were being reimbursed by any insurance company. And very early on, CMS led the way for Medicaid and Medicare, and also soon after, the private insurance companies have been reimbursing not only for video visits, but also for phone visits. So it was really this bundle of kind of policy changes that really decreased barriers to telehealth, and we saw the dramatic changes. And so our team really wanted to examine the impact of these policy changes specifically on buprenorphine treatment for opioid use disorder. So in a study that our team led, published last year in the American Journal of Psychiatry, we used an interrupted time series analysis to examine the impact of these policy changes implemented around March of 2020 on buprenorphine care. We examined the entire population of veterans in the VHA with opioid use disorder receiving buprenorphine, and we looked at what was happening to their treatment. What you see in this figure is pretty stark, I would say. So the blue line represents in-person buprenorphine visits. Unsurprisingly, before the pandemic, starting in March of 2019, we saw a fairly flat line representing in-person visits. But soon after, so within a month of the start of the declaration of the pandemic, you know, in-person treatment really tanked. I would say dropped by 80% or 90% very quickly, and I think many of us remember what that time was like. However, very soon after, or actually almost immediately after, we saw this tremendous spike in phone-delivered visits and, to a lesser extent, video buprenorphine visits that really largely replaced and, in some ways, exceeded our in-person visits. So that, on the whole, what our analysis found is that the monthly number of veterans receiving buprenorphine actually increased 14%. And that was specifically when we looked at this due to more patients continuing on buprenorphine, not due to more patients initiating on buprenorphine, which we can talk a little bit about why that might be. So overall, what we found was that the pandemic-related policy changes actually increased buprenorphine treatment. And this was a pretty shocking result because, if folks have looked at this literature for other health conditions, including chronic medical conditions, things like that, we actually saw a dramatic decrease in healthcare utilization in that first year after the pandemic. So the fact is that we were able to not only sustain, but increase care in some of the most vulnerable patients that we take care of, a very high prevalence of housing instability, homelessness, multiple substance use conditions, mental health disorders. It's actually pretty remarkable. In addition to trends, though, I think a lot of us are also interested in comparative effectiveness because what we really want to do is to disaggregate the effects of the COVID pandemic from the actual effectiveness of some of these treatments. So in a second study that our team conducted, this was led by Maddie Frost, who's a postdoc at VA Puget Sound, we looked at the cohort of patients with opioid use disorder in that first year after the start of the pandemic. So from March of 2020 through February of 2021. And we compared three separate groups of patients that were mutually exclusive. So the first were patients or veterans who had received any video-delivered buprenorphine treatment. Second were patients who had received phone-delivered buprenorphine treatment, but no video visits. And third were patients who had only received in-person visits for buprenorphine during that post-pandemic period. And what we found was that in the VA, the largest addiction treatment provider in the nation, among over 17,000 patients receiving buprenorphine, 88% had received some of it via telehealth. And most of those were actually from phone visits. We did also find differences in terms of which groups of patients were receiving which modalities. So patients less likely to receive telehealth were those who were younger, male, black, Hispanic, and those who had comorbid substance use disorders. Among people who had received any telehealth, patients more likely to receive phone visits for buprenorphine were folks who were older, black, and homeless. And what these differences indicate to me is that as policymakers are thinking about making changes currently in terms of what's allowed, for example, whether or not phone visits will continue to be allowed, what we know is that there will likely be outsized impacts for some of our patient populations. I would say most important of all, what we found was that for folks who had received any form of telehealth for buprenorphine treatment after we adjusted for all other patient differences, those who had received telehealth compared to those who had received only in-person visits were more likely to stay on their buprenorphine for greater than 90 days. And so for folks in this field, we know that retention on buprenorphine is probably one of the most important quality metrics that we have. And that's really what's been associated with the decreases in mortality that we expect to see from treatment. And so what we've learned from these studies, in addition to a few other studies, have now been published very recently, including some by Chris Jones and colleagues, and they looked at similar questions using Medicare data, is that, you know, we believe that telehealth policy changes that were implemented very quickly after the start of the pandemic really helped to sustain, in some ways, increased buprenorphine treatment for this vulnerable patient population. We also see that a lot of patients actually receive treatment via telehealth. This number really differs very largely across systems. So I provided in the VA, over 80% of patients receive telehealth. In the Medicare population, from Chris Jones's paper, it was in the 20s. So this obviously varies depending on the clinic and setting, but in general, these were obviously much higher numbers than we saw pre-pandemic. We also now have data indicating that telehealth associated with increased retention on buprenorphine, and from Chris's paper, they also found decrease in overdose rates, both measured within healthcare utilization data, but also mortality data. And I want to emphasize this. So although the U.S. and many other countries have now devoted billions of dollars to try to address the overdose epidemic, there's actually very few levers or innovative things that we know we can do to try to improve care and outcomes for this patient population. And so the fact that we have one potential tool that has been shown to potentially decrease mortality is actually a pretty important thing. At the same time, we have a lot of questions that are unanswered. The key things are around really deciding, I think, for all the clinicians in the room, so who do we offer telehealth to at this point in time as we've really phased out of the pandemic? And I'll really talk about that in the next couple of slides. And so, so far I've talked about what care for patients with opioid use disorder look like during the pandemic, but I think the more important question is what care should look like in the future. And to me, the most important thing, the goal that we should all be aiming for is the gold star. And what that means is how do we increase both access to care at the same time as quality and outcomes for patients? And a lot of folks, the reason why I emphasize this is that a lot of folks oftentimes conflate increased access with decreased quality of care, and that's really inherent to the debate of telehealth. This is why you see so much regulations, because of the concern that there could be misuse, that providers can really not be delivering high-quality care via telehealth. There's certainly the possibility for that, I would say. At the same time, I see these as independent factors, and we really should be aiming to improve both. The key thing, though, to do that is we have to be thinking about populations of patients. In a lot of our healthcare systems, we have a tendency, and we're certainly incentivized, to only care about the patients we see, not about the patients we don't see. For example, let's say a patient comes to you, you think they need a higher level of care, you refer them to a higher level of care, but then you never see them again. And with telehealth, what that oftentimes means is, should we be treating only the most stable patients with telehealth, or should we be treating less stable patients? And the important thing to measure is what happens to the less stable patient if we refer them on. Do they follow up, or do we never see them again, and those are the folks who actually need our help the most. And so when we think about access and quality, we really have to think about our entire populations of patients. And so some of the challenge right now that we're all facing is really the uncertainty around policy changes. I think a lot of folks are aware of this, but the DEA had issued draft guidelines knowing that the PHE was expiring, and with the end of the Ryan Haight online exemption, that only existed during a PHE. Did the DEA issue these draft changes? Actually, they've been working on them for years, I can tell you, but they issued them earlier this year, but there was such an overwhelming response. Over 38,000 folks commented on these draft changes that they actually have decided to delay these. And this, again, I think is an indicator that we don't have enough understanding or data to guide our policies. So the changes that they had originally mentioned were not only... In some ways, I was actually fairly pleasantly surprised by them because some of us actually thought that they would be much more stringent than they actually were. So what they specifically mentioned was really pertaining to that interpretation of the Ryan Haight Online Pharmacy Act. So the draft rules stated that after the PHE was supposed to expire, there were three routes to starting patients via telehealth on buprenorphine as a control medication. There were separate rules that pertained to other control medications, for example, other opioids and also other scheduled medications. I'm focusing here on the buprenorphine-specific guidelines. And so first is, first of all, we would still be able to continue or to be able to start patients on buprenorphine via telehealth, both phone and video visits, which was tremendous in my mind. But then after that, patients would be required to come in for an in-person visit within 30 days, or there were two other options. One was that they had to have an initial telehealth evaluation while the patient was also in the presence of another provider. For example, as a telehealth doc, I could video into a patient while they were having a visit with their PCP who was doing a physical exam, which is not something we ever do typically. The third option was the patient could have an in-person evaluation by their PCP, for example, and that PCP could refer the patient to me as a telehealth doc, for example. That's also very difficult because of the very detailed logistics that they specified. For example, they had to have a named provider in mind, which most of us know when we refer patients, we oftentimes are just providing some phone numbers. We don't have visit dates and things like that in mind. So a lot of the challenges with this draft rules, I would say, are around the logistics. However, these rules have been delayed. They've been delayed, I would say, for the time being. So they may, in fact, be enacted, let's say, later this year or next year. And I would say the key thing is that we need more understanding of what the potential impacts of having these rule changes are with our patients. And this is a time where research is typically very, very slow, as many people know. We usually conduct studies that don't get published for five years. But we actually need studies much more rapidly to inform policies that can have very real-world impacts on our patients. And lastly, I really want to talk about the clinical challenges that I think are outsized and will continue to affect our clinical care well beyond the pandemic and well beyond some of these policy changes. These clinical challenges are not just focused on telehealth, though sometimes I think these particular questions bring these challenges to the forefront. But they're really pertinent to our entire field of folks who are taking care of patients with substance use disorders. So I've had the luck and opportunity to give this type of a talk to several dozen audiences in the past now, thousands of clinicians like yourself. And I would say even now, three and a half years since a lot of us started using telehealth, there's just so much uncertainty about practice. A very concrete one is really, what's the use? What's the meaning? What's the purpose of urine toxicology screens? Because that is oftentimes correlated with telehealth visits. But I would say the other thing, and that might be more pervasive for our field, is really how do we take care of sick, complex patients, which again I mentioned are the norm, not the exception for a patient population. In the field of psychiatry, mental health, and also in the field of addiction, one thing that we have to acknowledge is that we have tremendous variation in our treatment practices. If a patient walks into one door versus if they walked into a different door, oftentimes their treatment may look completely different. And as I've shown you, because treatment has such an impact on outcomes, that might suggest that their outcomes might look very different too. So the key question I oftentimes get is the question of, well, with telehealth, a lot of folks feel comfortable using telehealth for a very stable patient. So folks who have not been using substances for months or years, that they feel very comfortable continuing to treat that patient via telehealth, either video or phone visits. But the real question is, what about the unstable patient? The patient who I work with who's unstably housed and I can never get them to come in anyways, but occasionally I can. Should we use more stringent or less stringent requirements for those folks? For me, as a clinician, I love to see all of my patients in person. I think most of us in the room agree, we feel very comfortable seeing our patients in our offices, right? But the real question is, what happens, however, for different patient populations if we ask them to come in versus if we provide telehealth? And that's not a question that we have any data yet to really guide. And I think that's a really important question to answer. And the specific thing also related to that is not only socioeconomic kind of factors, but also comorbid substance use disorders. In some of our studies, we've really found tremendous variation in clinician practices for patients, for example, who both have an opioid use disorder, but also a concurrent stimulant use disorder or a concurrent alcohol use disorder. How do we think about offering buprenorphine care to these patients differently? And what are the requirements we have about clinic visits, frequency of visits, frequency of urotoxicology screens? And these questions all come up in the setting of telehealth as well. And so I do think that for our field, we really need better clinical guidance to help clinicians really do the best care that we can provide. I think most of us have very good intentions, but we're working with very complex patient populations, and we're not sure what's the best thing we can do for them. And so recently with a colleague in family medicine at University of Michigan, we developed a toolkit titled Telehealth for Opioid Use Disorder Toolkit, Guidance to Support High-Quality Care that was supported by PCSS and SAMHSA. And in it, we really try to provide real-world clinical scenarios and how clinicians might think about it, especially at this point in time where a lot of our clinics are deciding whether or not we're gonna transfer all of our patients back in person or not. And the biggest thing we say is, do it very thoughtfully, because from our data, we really are fearful that some of our patients are gonna be lost to care. And that there might be unintended consequences behind the policies or decisions we make. All right, I'm gonna end there, and I'm happy to take questions at the end. Thank you. Thank you very much, Dr. Lin, for an excellent presentation. Our next speaker is Dr. Amy Campbell, who is a research scientist in the Division on Substance Use Disorders at the New York State Psychiatric Institute and an Associate Professor of Clinical Psychiatric Social Work in the Department of Psychiatry at Columbia University Irving Medical Center. Her research focuses on the development and testing of individual and program-level interventions for substance use disorders and co-occurring health and mental health challenges, including the leveraging of technology-based platforms with the objective of increasing adoption and implementation of evidence-based treatments. Dr. Campbell has been involved in addiction treatment and implementation research, primarily in community settings for over 20 years, including collaborations with indigenous partners to identify substance use disorder treatment best practices with tribal communities. Good morning, everyone. A small but hearty crowd this morning. Thank you for being here. And thanks for Dr. Mooney for organizing this symposium. Let's see. So, Dr. Lin, I think, gave a great overview with the telehealth piece that will be really relevant to what we're gonna talk about in this presentation, which is digital therapeutics for treatment of substance use disorders. And I'm gonna actually focus today on some adaptation work of a digital therapeutic with two different populations and in two different ways, just to kind of give you a sense of what that work kind of looks like and what are some of the opportunities and challenges there. Before we get started, just wanted to ask, how many, if any, of you have ever utilized a digital therapeutic with your patients? Recommended something, suggested something, had them look? Great. You led the way. A few more hands came up afterwards. That's great. And so, I think some of the questions around the adaptations will be really interesting as you think about your own clinical practice and what are some things you'd like to see with the current slate of digital therapeutics that are out there, and for others, for us to think about how we might integrate those. So, just disclosures and funding here. And I do receive grant support from NIH, SAMHSA, and HRSA. So, I wanted to ask that we just stop for a moment to acknowledge the original inhabitants of the land on which this meeting convenes. So, we acknowledge that we meet today on the unceded ancestral homelands of the Ramaytush Ohlone, the original inhabitants of the San Francisco Peninsula. As guests, we wish to pay our respect to the Ramaytush Ohlone ancestors, elders, and relatives who have been and continue to be stewards of this land and to affirm their sovereign rights as First Peoples. So, in this spirit, and with the idea that land acknowledgments are just a start, and that action after those is really the most important part, I invite you to visit these websites to learn more about the Ramaytush Ohlone people, and to consider a donation to their nonprofit association, or to the activities and initiatives described on the American Indian Cultural District site, which is the second link there. The Association of Ramaytush Ohlone represent the interests of the original peoples of the San Francisco Peninsula, and they partner with other organizations and agencies to pursue objectives related to rematriation of ancestral homelands, cultural revitalization, ecological restoration, and community service. Thanks. So, this is the agenda for the presentation today. I'm just gonna give a brief overview, kind of hopefully starting where Dr. Lin left off in terms of digital therapeutics and how we might leverage their promise for our client population, talk a little bit about intervention characteristics of digital therapeutics. I'm gonna give a couple of examples of two adaptations, and then talk a little bit about opportunities and challenges. We'll go through this material quite quickly, so it's not about understanding kind of the specific details of these studies per se, but just to kind of give a sense of what we're talking about and how we might move forward. So, this slide just shows some of the potential ways in which technology can address some of these really long-standing substance use disorder treatment barriers. And again, Dr. Lin referenced a number of these but I'm gonna talk specifically about digital therapeutics, and digital therapeutics are really these, using digital platforms to deliver treatment interventions for substance use disorders. So, talked already about accessibility and availability, but the potential for tech-based solutions to really be on demand. They are not situated in a brick and mortar building, or even with the times that providers are available. So, this is a great example of the potential for real-time interventions. So, this is real-time response for when people might need them, and the way different interventions are set up means that people can access different components of interventions when they're most needed. Stigma. The big thing that's always in the room around substance use disorders. So, these digital therapeutics can offer confidentiality, they can offer anonymity in many ways. You don't have to actually walk through that door Lack of treatment standardization. So, we know, especially following the pandemic, that there are significant workforce issues. We don't have enough addiction specialists providing care right now, and so this can be a consistent treatment delivered with fidelity, and also done with limited training, which can often lower costs. Traditional treatment barriers are kind of a one-size-fits-all curricula. So, we're operating it with this lower workforce, here's what we have to offer, I hope it fits what you need. Digital therapeutics can offer customized self-learning, titrating the dose on your own of what you might need at any given time. And as Dr. Lin mentioned, substance use disorders are a chronic ongoing treatment model, and a lot of our addiction specialty services are not really set up in this way, which is why we want to lean more heavily on our general healthcare practitioners, as well as our specialty providers, and digital therapeutics can really be an adjunct to some of this care. So, the intervention that I'm gonna be talking about today was first started in the early 2000s as a computer-assisted intervention. It's called the Therapeutic Education System. It was developed by Bickel, Marsh, and colleagues, again, in the early 2000s, and it's comprised of two evidence-based treatments. So, it's a combination package intervention of both the community reinforcement approach, which is a very relatively straightforward cognitive behavioral intervention, although it's typically, in the past, has been delivered in person over a three-month period of time, and has required a lot of extensive training and supervision for providers to deliver it. So, it's this kind of pretty needy cognitive behavioral package, and putting it on a digital platform has allowed it to be delivered a little more easily. Those, the community reinforcement approach components are offered in modules, typically with interactive audio self-directed use, and there's fluency-based learning attached to those so that you can kind of get a sense that people are really integrating the information that they have. The other component of TES is contingency management or motivational incentives, and they're typically offered for both completion of modules as well as for substance use or lack of substance use. So, TES actually has some of the most robust research behind it of pretty much any substance use disorder digital therapeutic. So, you can see on the left there, the first efficacy trial was published in 2008, showing that TES was comparable to therapist-delivered community reinforcement approach and contingency management. We've also seen trials that have shown that TES enhances abstinence over just treatment as usual in addiction specialty program, and that TES benefits over contingency management alone. So, really understanding that the psychobehavioral component is effective. And then, there was a large effectiveness trial published in 2014, of which I was one of the co-investigators and this showed that when added to treatment as usual, TES promoted greater abstinence and retention. So, this is kind of the background on which TES moved into becoming a digital therapeutic app and some of the cultural adaptation work. So, what I'm gonna talk about today is some work that we've done over the last 10 years. It's a cultural adaptation of TES with urban American Indian and Alaska Native individuals in an outpatient treatment setting. And I'm gonna talk about kind of the timeline and model for how we did that work. And then, I'm gonna talk about a gamified version of what TES became when it was purchased by Paratherapeutics and is known commercially as Reset or Reset-O for opioids. So, before we get started, just because I am an implementation scientist, I gotta throw in some implementation conceptual work. But this slide really lists the characteristics of interventions that promote their successful adoption and implementation. So, these are aspects of any intervention that would lead us to think that these are actually going to make it into community-based care, scaled up and sustained. And what I've done in the red circles is just show some of those characteristics that these adaptation trials might try to influence. So, compatibility, fit with end user audience and needs. So, what we're really doing with adaptations are making them more compatible with whomever is the end audience at any particular setting. Design quality and package, especially with the engagement adaptation that we're gonna talk about. So, really improving the quality of what you're seeing and how it's rolled out to make it more likely that these interventions are going to be scaled up. And then, in terms of cultural adaptation, we know that, based on the literature, that cultural adaptation contributes to increased acceptability and, oftentimes, effectiveness of substance use disorder interventions. But there's considerable variation in how that content is adapted and, probably most importantly, how that's reported. And so, there's an issue around the consistency of reporting of adaptation efforts, what particular components are being adapted and what we can learn from those things. In a recently published chapter of a book, these four recommendations were made around cultural adaptation. So, one is to utilize frameworks. So, let's make this systematic and let's make this something that we can replicate. We have to engage key partners. So, we have to take it out of our academies, into communities and really work very closely with the end community around what these look like, document modifications and really explore some of these implementation factors, what are the barriers and drivers to technology use as we move forward. So, the first example is a cultural adaptation. Again, we did with urban American Indian and Alaska Native individuals. So, these are folks that primarily live off tribal lands or reservations in urban centers. And the vast majority of American Indian and Alaska Natives in the U.S. do live off tribal lands, about 70%. So, we know that cultural and traditional practices of Native folks are associated with positive health outcomes. We often hear culture is health and so that was one of the main rationales for thinking about an adaptation of TES for this population. We know that there are lots of social structure and historical factors that have created substance use disorder disparities. And this is despite cultural values that often prioritize abstinence. And limited access to and resources for culturally appropriate best practice, especially in urban areas. So, there may be treatment programs on tribal lands, reservation-based programs that do offer that cultural component. It's less likely in urban areas. And so, a culturally acceptable digital therapy might help bridge this gap. So, this is the adaptation model and timeline that we used. And as I said, it's a labor of love. This is work that's been done over the last decade with various funding sources. But really, with a community advisory panel that's kind of stuck with us the whole way. So, we started with a pilot acceptability study that was linked to that large effectiveness trial that I talked about at the beginning, where we looked at acceptability issues and we looked at ways in which a potential adaptation, what that might look like with 40 participants across two programs. We did that adaptation work in 2015 and 2016, really utilizing our community advisory board in kind of an iterative revising process, where we folks looked at each one of the modules, the CRA modules, and looking for things around language, things around relevant examples. And so, did that modification and with a couple of different iterations. And then we did receive funding from NIDA and our 34 three-year grant to look at this adapted version of TES, which we called TES-NAV, TES, the native version, just to see, look at preliminary effectiveness. And so, I'll just present a little of that data. Just so you are aware, these are some of the examples of the modules. And so, you can see a lot of, you know, general kind of relapse prevention skills building modules, but a lot of things around interpersonal and social activities with CRA, really helping to promote kind of more pro-social reinforcers of not using substances. And this just gives you an example of some of the module revisions that we did. Some of that language that we took into account, making it more relevant, acceptable, and appropriate for urban American Indian Alaska native populations. And so, for example, using strong body language, make good eye contact and look serious. So, our advisory members, you know, pointed out that sometimes making good eye contact is not appropriate in native communities. It's a sign of disrespect. And so, we made changes to that language. So, consider your body language, make good eye contact if comfortable, and look serious. We also redid all of the video clips. So, video clips are used within TES to help demonstrate different skills and how to utilize those. So, all new videos and all clips as well as scripts. And we did this with our community advisory board and we also did this with four or five native actors that we worked with actually in Portland, Oregon to revise some of these videos. So, this is the pilot randomized control trial that we did as part of this NIDA grant and just to point out here, we looked at treatment as usual, so all folks were getting an intensive outpatient treatment actually in a native program on the west coast, but in an urban setting. And then we added TESNAV, the adapted intervention, to that treatment as usual over a 12-week trial. So some of the participant characteristics, you can see here, they were all identified as American Indian or Alaska Native, as well as other racial categories. About half were women. And then I just put at the bottom there, the total modules completed in this small pilot, we had a mean of about 23, but the median was about 12, and we were looking at just the core TES modules had been adapted for the purposes of this study, which were about 26. So okay engagement, not the greatest, but we can talk about that at the end. Our primary outcome was longest consecutive weeks of abstinence. So this was a preliminary kind of efficacy study. So we had a substance use main primary outcome. We chose this one because it has good prognostic value in terms of folks in substance use disorder treatment. This was not significant. The secondary outcome was not significant, but you can see that it looks promising. I may have slightly rose-colored glasses, but it looks promising in terms of more people are in the higher number of weeks of consecutive abstinence in the TESNAV arm, about 35% compared to about 20%. These are the secondary outcomes. We looked at retention, we looked at coping, we looked at social connection, and we looked at the percentage days abstinence after treatment and the three months after treatment. And you can see that we did have a couple of significant secondary outcomes, I think interestingly around social connection, which might be a very important construct, especially for this population, and as well as kind of that longer-term impact of TESNAV in terms of post-treatment, so after the intervention ended. So I just quickly want to talk about the gamified adaptation. So as I mentioned, TES was purchased by Paratherapeutics, which was a digital therapeutic startup, and they got FDA clearance of TES, and the commercial name was Reset, and Reset-O was the opioid version. So the rationale for the gamified version is that the therapeutic content was delivered in a pretty kind of academic didactic way in the original TES, and then what got moved over to the app-based platform. So the idea is to create more of an interactive game-like environment with PAIR-008, that's what we called this adapted version, with the goal of maximizing engagement and satisfaction. And this was funded by NIDA and SBIR, which is specifically a business innovation research grant, and again, a 12-week trial. So I just wanted to kind of give you a sense of, this is the Reset-O, kind of what it looks like. It's a little dry, especially when you think about the apps you all use on your phones, like this is not one you're going to be rushing back to necessarily. That's the idea for the gamified version. It does have the contingency management component on it as well in this kind of spin-the-wheel format. So for PAIR-008, again, this is the therapeutic content reformatted, utilizing this kind of game economy of virtual and tangible rewards. So not just the contingency management as we've described it before, but also this within-app, intangible or virtual rewards. And the development of this occurred over two phases. The first is formative interviews with people with opioid use disorder and feasibility testing. So we created one module and kind of went through some iterative feedback with folks with a lived experience. And then in phase two, iterative testing as we further developed out the gamified version, and then looked at engagement in a small randomized control trial, comparing PAIR-008, the gamified version, to Reset-O, the original app version. So the concept is that you have this nature window that you open up and see. And you can kind of start adding things to this environment within the app. And so completion of treatment lessons earns stars that unlock virtual and tangible rewards. And the lessons can be done multiple times to increase your stars and earn these things. So it really tries to motivate people to utilize the app as much as possible. See adding birds and other things to your home screen. These are the rewards. So a little bit more exciting than just the spin the wheel. And then again, therapy lessons were divided into shorter chapters to provide smaller, more achievable goals. And then fluency training was integrated within lesson chapters rather than at the end of the lesson. So as you went along, you kind of had these fluency-based quizzes and things like that rather than doing the whole lesson and doing it at the end. So in this trial, there was 52 participants. It was just completed last fall. Again, about 50% female, about 90% white. We did recruit virtually. This all took place during the pandemic, so we switched to an entire virtual trial and utilized some telehealth buprenorphine providers primarily to do recruitment. So the primary outcomes here, these are just preliminary. So the mean number of active days in that 12-week period was 21 days, about 22 days for Para-008, the gamified version, versus 31 days for reset. So that was not necessarily in the direction that we were thinking. The mean number of lessons completed, so there were a lot more completed within Para-008. But that was partly because of the way that it was set up, where it was broken down into kind of smaller lessons, and you were encouraged to complete them multiple times to earn more and more stars. So one thing to think about this is, you know, maybe to look at kind of knowledge and skill-based acquisition. That could have been really enhanced with the way that this was set up. And there was slightly higher retention in Para-008 at the end of the 12-week study. So lots to unpack there, and hopefully that data, we'll be able to dig into that. So just a summary of these studies. It's further evidence of the impact of adaptation on engagement and effectiveness, but also lots of questions. One is around metrics. What's the most appropriate construct to measure in these adaptation trials, including in, you know, taking an evidence-based intervention, doing some adaptation work with another population, and then, you know, NIH suggesting we still needed to go through that preliminary efficacy study process. I think there's questions about that, about, you know, how can we move through these research processes more quickly with some of the information that we know? There's challenges with tech resources in smaller studies and in managing and testing new development. So you're working on a shoestring budget. You're still trying to put out an app that will be comparable to the apps that are out there built by these large companies. It's a really hard task. And so I think that's something that we have to think about as a research community and as a clinical community as well. And then the specific populations. Each population is going to probably respond slightly differently. How do we take that information and generalize it across other populations so that we're continuing to build this adaptation information and not starting from scratch? And then finally, just some concluding thoughts that I'd be happy to think through further with you all in the Q&A. Again, when and under what circumstances are adaptations needed and for whom? And what's the added value that is important? I think that those are still questions out there. How does adaptation enhance engagement and adherence? It's impacted by lots of things. There are key tech features that we know are associated with better engagement. But I also think in terms of substance use disorders and the chronic nature of those, people need different things at different times. And so having one metric or one line that we need to get over for all folks, I'm not sure that's the best way to go. And so it may require some more in-depth information gathering from people. And technology-based platforms are a good way to collect all sorts of additional information, including real time. And then just some of the scaling up. So from clinical trials to implementation. So there's lots of things to think about. There's different pathways for these digital therapeutics to be scaled up. And I would just note, and some of you may have heard that paratherapeutics has gone out of business. And so some of these things are being kind of sold off to other folks. We hope they're still going to be made available. They chose one pathway to implementing Reset and Reset-O through prescription and through insurance reimbursement. So that's one way to go. But we need to explore lots of other ways to go as well to make these more available. So I'll stop there and just some of the acknowledgments of lots of folks that worked on these trials. Thanks very much and look forward to Q&A. Thank you so much, Dr. Campbell. Our next speaker is Dr. Dawn Sugarman, who is a research psychologist in the Division of Alcohol, Drugs, and Addiction at McLean Hospital and an assistant professor in the Department of Psychiatry at Harvard Medical School. She received her doctorate from Syracuse University and completed pre-doctoral and post-doctoral fellowships at Yale School of Medicine. Dr. Sugarman's research primarily focuses on the use of technology in increasing access to evidence-based treatments for substance use disorders. Her work emphasizes special populations such as women and individuals with substance use and co-occurring psychiatric disorders. Dr. Sugarman is a current recipient of a NIDA-funded career development award focused on increasing women's engagement in medication treatment for opioid use disorder through digital intervention. Hey, good morning. I'm honored to be part of this symposium and thrilled to follow two really great presentations. So what I'm going to focus specifically on is using digital interventions to address the needs of women with substance use disorders. As far as disclosures, I received grant funding from NIDA, but I have no other relevant financial conflicts of interest. So what we know is that overall, the prevalence of substance use disorders is greater in men than women. However, what we've seen, particularly over the past couple of decades, is that that gender gap is really narrowing. And it's happening both in the U.S. and internationally. So these data are from the National Survey on Drug Use and Health comparing 2013 rates of substance use disorder to 2019. And what you see is that when you look broadly at age 12 and over and age 18 and over, you see that higher prevalence in men than women. But if you look over here, when we get to this younger age group, when we pull that out, the 12 to 17-year-olds, you can see that in 2013, those rates were nearly equivalent. And by 2019, women had surpassed men in prevalence of substance use disorders. These data pull out high school students from the Youth Risk Behavior Survey. And if you look at the different categories, for marijuana, it's nearly equivalent. But for alcohol, binge drinking, and prescription opioid misuse, you see all of those are significantly higher prevalence of use in girls than boys. We see the same thing for alcohol use. So this data tracks from 2002 to 2018. And this is that broader group of 12 and older. And you can see that over the years, past month alcohol use and past year alcohol use disorder, those lines start to converge. But again, when we pull out this younger age group of 12th graders and look at the trajectory, you can see that over here, by 2018, there's basically no difference between boys and girls in drinking in the past month and getting drunk in the past month. So the concern for this is that what we see for women is called this telescoping course of illness. So from the time that women first start using to when they develop a substance use disorder and then need treatment is a much shorter time period than what we see for men. And so when they enter treatment, they've had fewer years of use, but they have more medical, more psychiatric, and more social consequences than men. We've heard a lot about barriers to treatment. These are some of the ones that are more specific to women. So despite the fact that they have these more adverse consequences, they have additional barriers to accessing treatment. So pregnancy can be a barrier. There are fewer addiction programs that treat pregnant women. And there are also concerns for pregnant women with substance use in getting treatment for there are several states and other places internationally where they could be prosecuted for seeking treatment or using substances when they're pregnant. Child care is a barrier for women. They can't access treatment if they don't have child care. We've heard about financial costs. And for women with substance use disorder, they have higher rates of trauma and other co-occurring mental health disorders, particularly depression and anxiety, that can be a barrier for treatment. And then lastly, I know we've heard a lot about stigma and substance use disorders from my co-presenters. But what we know from the research is that for women, they consistently feel that the stigma is stronger for women with substance use disorder, and that can be a big barrier for them accessing treatment. So given all these factors, there was a push to develop gender-specific treatments to address these things, the co-occurring mental health disorders, the trauma, pregnancy, child care. And what we know from the research in this area is that when women access gender-specific treatment, they have better outcomes. The problem is that it's very difficult to access this type of treatment. These data surveyed substance use treatment facilities looking at their specifically tailored programs, and you can see that for these facilities, less than half offered specific programming for women. And then when you go down the line of the things that differentially affect women with substance use disorder, trauma, sexual abuse, intimate partner violence, you can see that those numbers are really small. So very few of these facilities are offering that specific programming for women. The other issue with barriers to accessing gender-specific treatment is that our treatment programs are primarily made up of men. So these data show from 2003 to 2014, our programs have 70% men and about 30% women, and what you can see is really those lines haven't changed over the years at all. So it can be very difficult for programs to implement a gender-specific treatment when they have a handful of women in the program at a time. So that's where we can really use technology to bridge the gap, and I think that my co-presenters have done a nice job of discussing many of these things, so I'll focus on the ones that are more salient to this gap in accessing gender-specific care, but technology can be a way to reach more people, we can reduce some of those geographic barriers, we can also help for women who have difficulties accessing treatment because of childcare. It can be cost-effective to implement a technology-based program where it may not be as cost-effective to implement an in-person women-specific programming, particularly when you have an overwhelming amount of men in the program. As Dr. Campbell mentioned, these can be accessed in the moment, outside of our clinical settings. You can also individualize and tailor the programs based on characteristics of patients, and for those who particularly are struggling with stigma, they can access these programs in an anonymous way. We also know that for women, it can be really acceptable, these digital interventions. So we've seen in the evidence that women seek out health-related information on the internet more than men. In our own substance use disorder treatment program at McLean, in our inpatient treatment, we surveyed our patients and found that more women than men actually expressed interest in using a mobile app as part of their substance use disorder treatment. And in this study of web-based intervention for individuals with substance use disorders, this was actually the TES study that Dr. Campbell mentioned, women had higher acceptability ratings of the digital intervention compared to men, and that acceptability was positively associated with abstinence in women, but not men. So we know that this is a feasible and acceptable way to offer treatment to women. So given all this, we wanted to look at whether we can take evidence-based, gender-specific treatment and adapt that to a technology-based platform. So we use the Women's Recovery Group, which Dr. Shelly Greenfield developed, and it's been studied in a stage one and stage two randomized controlled clinical trial. It's been found to be effective for women with substance use disorder. This is traditionally meant to be delivered in person. It's a relapse prevention group therapy with women-focused content. There's structured sessions that the women go through. So we wanted to see, can we take this and adapt this to a web-based platform in order to increase access? So what we did, so typically the in-person group is delivered over 12 sessions, 12 weekly sessions. So we started first with three of the topic modules that we felt were most relevant to women. So the effects of drug and alcohol in women's health, managing comorbid disorders, particularly mood anxiety and eating disorders, and women and their partners. And we adapted those three modules. We did a pre-pilot study, and then based on the feedback we got from that, we added two more topic modules, one on violence and abuse, and the other on women as caregivers. And this is a web-based program. Typically, women accessed it on an iPad in our studies, but it can be accessed from any device where they can access the web. So as far as the components of the intervention, there's a psychoeducation component with women-focused content. We offer some resources that women can access. There's introduction to coping skills. We have these interactive questions throughout to keep women engaged. And then we also put in these knowledge check questions to see how much they're retaining the information. And then each of the topics ends with a take-home message. So what we did is in the pre-pilot study, so that was the three modules, we recruited 30 women in our mixed-gendered inpatient substance use disorder treatment programs. And then once we made the adaptations and added the two more modules, we went back and recruited 60 women across our continuum of care. So we recruited from our inpatient, our partial hospitalization, and our outpatient treatment programs. And we kept the criteria really broad. They just had to be 18 years or older. The intervention's in English, so they had to be able to understand and read English. As far as exclusion, we only excluded people who had either acute medical or cognitive impairment that would impede their ability to interact with the program. The sample characteristics for both studies were very similar. So on average, they were about 40 years of age, predominantly white, mostly unemployed, and about half had children. Typical of what we see of women with substance use disorders, there was a high degree of comorbidity of particularly depression, anxiety, and PTSD, which wasn't a surprise. So as far as results, the women were really satisfied with the intervention. They really liked it. They thought it was easy to use. They thought it was visually appealing. In particular, they thought the gender-specific information was helpful. So this was designed as a single-session intervention that they engaged with. So for the three modules, it took about 26 minutes for them to complete. And for the five, it was about 41. And we didn't find any difference by level of care regarding satisfaction. We also asked them, of all the elements in the program, what they thought was the most relevant to their recovery. And you can see that for both studies, it was very similar and not surprising, particularly around the comorbidity piece. And self-care was something that they thought was really important. We collected qualitative feedback as well. One of the things we wondered when we implemented this is that some of these women had been in and out of treatment 20 or more times. And would they just say this was all information that they knew? And what we found was, overwhelmingly, that was not true. As this woman said, just learning all this information is crucial for all of women. I was unaware of a lot of it. And I put this second quote up here because it really speaks to the technology piece, where this woman was saying, it's really helpful to see the information in this way in groups. It's great to be able to discuss these things, it's easy to miss something. So having it all laid out in an iPad like this is really helpful to remember everything and also see it visually. So you can see that it can also be a complement to what they're doing in their in-person treatment. So those studies that I presented were done in our addiction treatment programs with women who had a substance use disorder. But we have several programs within the hospital that treat women and girls with a primary psychiatric disorder, and they also have co-occurring substance use. And we wanted to see, could we adapt this to those women so that when they're coming in to get treatment for their primary psychiatric disorder, they're also addressing the substance use in a gender-specific way? And for this study, we focused on that younger age group because what we're seeing, as I showed you earlier, is that that age group is really increasing in their substance use. So we started off with a needs assessment. We wanted to understand what's happening when they come in for treatment and what are the gaps. So we interviewed 15 women, and we recruited them from inpatient psychiatric treatment and residential treatment. And we did qualitative interviews to assess what their experience is like in treatment, how the substance use is addressed, and what are their needs. And we transcribed and coded all those interviews for themes. And what we found was that 2 thirds of the participants mentioned ways that the substance use was not either adequately addressed or not addressed at all. As this person says, I'm clearly addicted, and I think it's a huge part of PTSD, but that's not really addressed in any of the classes or anything. A third of the participants mentioned that there was a lack of any sort of integrated treatment, meaning addressing the ways that the disorders affect each other. So as this person says, it's hard to treat all of my other issues when there's substance abuse in the background. That would be really helpful to look at substance abuse in conjunction with my other psychiatric and medical conditions. So we took all this information, and we adapted the first version that we had made for the women with substance use disorders. And the major changes that we made is not surprisingly, we expanded the information on the connections between mental health and substance use disorders. We increased the interactivity. That's something, I say, every study that we've done for technology, the participants always want more interactivity, which you can't blame them. So we added more coping skills practice. Particular to this group, this 18 to 25 age range, they were really concerned about navigating peer relationships, particularly when they left the hospital for those who wanted to stay abstinent from substances. How would they do that while being in a social setting with peers? So we added some information around that. And we also had several women who recognized that there was a connection between their menstrual cycle and their either substance use or their craving for substances. So we added some information around that as well. So once we made those adaptations, we went back to do a pilot study. We recruited women, again, from our inpatient and residential programs that treat primarily mental health. And for this study, they didn't have to have a substance use diagnosis, but they were identified by their clinician as having problems with substance use. And what that meant is that there was a group of these women who went through the pilot study who themselves did not recognize substance use as problematic. So the age range is reflective of that restricted 18 to 25 range. So the average age was 21, about 86% white, and 18% Hispanic or Latina. And most of these were students. So when we looked at primary diagnosis, you can see that most of the women had a mood disorder, either depression or bipolar disorder, and that some had borderline personality disorder, anxiety, PTSD, or eating disorders. What we found was that the majority were either very satisfied or mostly satisfied with the intervention. In addition, 93% of participants reported that they had an increase of knowledge post-intervention. We also asked them to rate pre- and post-intervention their willingness to make changes to their substance use and their interest in doing so. And we found that there was significant increase in those things pre- to post-intervention. This was not a controlled study, but I think it's an important signal, particularly for those women who didn't even recognize substance use as problematic when they started the study. We also, again, collected qualitative feedback because we want to keep iterating this program and modifying it. So we asked them after each of the topics what they liked and then what they would change. So as far as what they liked, they liked the information. Many of them said that they could really relate to the content. And they liked the interactivity. And then for this program, given the interest around navigating peer relationships, we added what we call these real-life scenarios, where we gave them a situation with a peer, and then we asked them how they would cope with that situation. And then we also asked them, do you think this situation was realistic? And if no, what changes would you make? I think they're only as valuable as as much as people can relate to those scenarios. As far as changes, as I told you before, everybody wants more interactivity. We had several people suggest content or wording changes. And despite the fact that they liked the real-life scenarios, several women said that some of them were a little too black and white, and so they wanted to be a little more nuanced, and they offered some great suggestions for that. The program does include LGBTQ resources, but the women asked for more of that as well. So where we're hoping to go next is these studies were limited. The samples were limited in racial and ethnic diversity, so we hope to expand that. As I said, we didn't have a control group, and we didn't collect substance use outcomes on these women. So we hope to incorporate the feedback that we got to further iterate and modify the intervention, examine that in a larger randomized controlled trial, and then collect some follow-up data. We also are currently looking at tailoring this for women with opioid use disorders, and I'll just briefly show you what that looks like. I won't have time to go through the results, but just give you a sense of where we're at. So this study is funded by NIDA, and the overall goal is to increase women's engagement in medication treatment for opioid use disorder through digital intervention. As you heard earlier, if we can retain people in medication for treatment opioid use disorder, then that's gonna have a better outcome, but we have a long way to go there. So the study has three phases. There's a formative phase, which we have now completed, where we interviewed treatment providers to ask them about the needs for women, and then we interviewed women as well. We've transcribed and coded all of those interviews and used that information to inform the development of the digital intervention. We've created a prototype now, and right now we're in the process of testing and refining that prototype so that we can move on to the pilot study, which will be a randomized controlled trial. I want to just acknowledge, and by acknowledging my mentors, collaborators, and research staff, as well as the funding, and I will turn it over to Dr. Mooney for the Q&A. Wonderful, thank you, Dr. Sugarman and all of our presenters today. We now have a few minutes remaining for questions, answers, discussion. I do ask that you come to the mic if possible so that the recordings capture your questions, but if you can't for any reason, I'll just repeat the question. Let's start. Mike Dawes, VA Boston and Boston Medical Center. VA National and VA Boston in particular have been doing a lot of different developing tools that are digital therapeutics and related types of instruments. We're fairly far along, but the big issue in terms of implementation is the firewall situation, that the information that we're gathering on the tools, there's so many levels of privacy and stuff that we're having to negotiate with folks that are concerned about that to get that information to the clinicians and the clinician researchers that are wanting to use that information in different ways. I'm just wondering what the panel's thoughts are of how to address that and move that forward, because I think that's a barrier addition to everything else that we've talked about in this and related meetings, that if we don't get past that, it's like we're kind of dead in the water. So just thoughts about that. I would just be curious, how much of that do you think is kind of within the VA kind of layers and how much of it is broadly kind of developing all of these types of novel interventions? Well, I can only speak for our experience and I don't know that I, I don't wanna give too much of our dirty laundry, but I think there are a lot of issues in VA Boston about and concerns about that, but I don't think that's unique to VA Boston. So I'm just be interested in your experience in Michigan and other folks that are beginning to think about these issues. Yeah, I mean, I think there's lots of issues around this and then a lot of it depends on how you're planning to implement it, whether it's within your system, whether it's within your current IT system, whatever that looks like, or whether it's a standalone or outside of it. I think people have gotten around it in terms of just the consenting process and really informing your patients of all of the different aspects of their care and what are the controls around that and they're consenting to different things and these ideas around universal consents and things like that. In our EHRs and our patient portals and all of those sorts, I mean, those are all very active discussions and it's probably one of the biggest areas of discussion around these digital therapeutics, but I think it would depend on kind of how you were going to integrate it into the infrastructure of your setting and then where you could get these approvals from patients. The other thing I was gonna add to that was I think a lot of us, especially who are clinically trained, we're pretty horrible at things like tech transfer and things like that. I know I am. So I know, I think depending on your local institution, kind of relying on those resources, but I've also found that it just takes so long to build those relationships, to help other people understand what you're doing, what you're not doing, what the potential risks are, what the potential risks are not. And one thing that we've tried really hard to do, this applies not only to tech transfer, but also like IRB and stuff, is really conveying like what the alternative is for a patient population that oftentimes, especially if we're working with untreated patients, you know, that these are things that when you think about risk or when you think about some of these other considerations, the alternative is actually much worse for these folks. And so how do you really compare like what are the potential downsides? But I agree, like these are not things that I was ever trained to think about. And then there's other people who have expertise, but then kind of helping them understand our patient population and the clinical piece has been important, but I agree, you see a lot of differences across institutions with that too. Okay. But I came this morning, you know, very hopeful and I'm even more hopeful, but I'm also hoping that I'm not deceiving myself. So I'm a psychiatrist. I work for a very large payer. And what I see on a daily basis is not what you see in academia. We're seeing very large populations in some specific states, particularly. And the big challenge is that what's being delivered out in the non-academic world, I'll say, is largely programmatic treatment where people are put someplace and they sit through copious groups or programs. And there's very little in the way of evidence of outcome or what's actually happening. So my hope was that this would be a more individualized specific kind of intervention, which is what I think I've seen. So I'm hoping I'm awake enough that I'm taking it in and not just continuing to dream here. But my question, and so my question behind that is, is that in fact what we're doing, that you're creating something that will be very specific and individualized, especially relative to what exists? And my question really is, is there a potential to link this to an active guide or a resource that the individual can reach out to in a more personal way during times of particular crisis or for guidance or for something else to be able to kind of mix the personal therapeutic relationship with this highly individualized kind of ongoing exercise? Did you wanna? I just wanted to comment. I think VA's very sensitive to that. How much that translates, I mean, there's a whole library of apps that us, Palo Alto Society and Washington State are developing. The issue is how to translate that outside of the VA because it's a system that has very unique resources, but they don't necessarily translate to outside of that. But I think there's lessons that can be learned or collaboration with what we're doing outside would be helpful for the field. Well, I would just respond in terms of your, I'm glad that you're optimistic. I didn't wanna make people less optimistic because I think there is a lot of room here for really great stuff and a lot of personalization. I think where some of the things, some of the places where we need to think through is exactly around what you're saying in terms of how are these integrated into systems and or how are they kind of standalone? And when they're more standalone, who does respond to some of the needs of patients using these different digital therapeutics? And I think those are some things that we have to think through. But I think in terms of the personalization, absolutely. And that's growing based on kind of these in real time metrics that are being collected and then you can personalize the responses that come up or the activities that people can do. So I think there's lots of room in that space. But I think clinicians and the folks who are developing these applications need to talk a lot more with one another to really understand the landscape and support the information sharing. Yeah, I would just add that I think there's some interesting work being done on when we need to step up to either a live clinician, if someone's using something that's outside of the clinical setting, people are looking at whether there's an in between step of using AI to sort of address some of those issues before stepping up to connecting someone with a live clinician, again, to sort of reduce that burden on, we don't have enough clinicians that can constantly respond to these programs. But I think there's still a lot of work that needs to be done in that area around AI and any concerns about when they get it wrong, essentially. Next question. My question is about barrier that we talked about, the stigma and distance and many other I, my thinking is that we clinicians work hard in our academic centers of research and community clinics and we are majorly successful in treating patients and they go out in the same environment. And this is my comment about the environmental resistance. I think we have barrier in the general societal environment. Our legislator, for example, that there's a lack of information. I think the epidemic of misinformation or perceived harmlessness that kids in formative years, in formative years, we see them getting into marijuana and there's more liberalization around the states. So I would like you to address this issue, but I think there's too much out there which is a barrier and we keep on working hard. We should have some answer to that environmental issue. Thank you. So the question, just to summarize the question then is how to overcome barriers that are happening in society with misinformation, even with legislators around acceptance of some of these more novel. In addictions, we know about the cross addictions. They develop in the formative years and there's major misinformation or perceived harmlessness that we know which exists out there. And we keep on working hard with our patients with much success. But on the other hand, they go into the same environment where there's a barrier. I wonder if Dr. Lin and others could address. I can touch briefly on that. I agree that as clinicians, but I think the other side of it is we only see the tip of the iceberg, right? We see the folks who walk into our doors which we've shown is a very small proportion of patients. And honestly, we only have let's say 10, 15 minutes with our patients and then they go out and they live the rest of their lives which might be weeks or months until we see them. So I agree that we oftentimes underestimate the impacts of the rest of an individual's life on their substance use, their behaviors, their mental health symptoms. I think bringing that back to kind of some of these discussions, that's why I think a lot of us work kind of more on the public health front, right? How do we think about different types of interventions, not just the one-on-one treatment that we provide to patients, but how do we think about lighter touch interventions that can reach across people? Some of it is some of the technology type interventions that we talked about. But there's also lots of other things that as clinicians we don't think about. For example, interventions that occur in social media and things like that, that can be deployed with far less effort. There's certainly implementation challenges there too. And I think kind of going back to the prior question, it's like how do we combine some of these different tools and how do we figure out which person needs what combination? As clinicians, we oftentimes are pretty poor at talking to patients about all of these things. Oh, are you using other types of digital therapeutics and what's my role in that and things like that. And so we can't always rely on ourselves. But knowing that a lot of our patients don't need more than just us and oftentimes can do very well with information that they receive from lots of other places. We certainly know they're influenced by that. So how do we use that for more good is maybe another way of looking at it. Yeah, and I would just to bring it back to kind of these digital platforms. I think we're always looking for something to provide our patients when we see them in front of us based on what they're presenting with. And so if we had a range of tools from primary, secondary, tertiary prevention through treatment, through recovery. Because I think, as Dr. Lim mentioned, the referral process is like we don't know what happens for the most part when we refer and people head out. So I do think there's a space to address some of the issues that you raised by having kind of a suite of different tools that people could say, well, try this out for a little bit, see what you think and then come back. So I think there's a space within the digital platform range to address what you're talking about. And I would just add on to what Dr. Lim said around the public health piece and the potential for the technologies to really scale up. And one of the things we found with the young adult woman is that the information really resonated and it was something that they'd never heard before. Just basics that women metabolize alcohol differently and their blood alcohol content could be higher than a man of the same weight drinking the same amount. I mean, that's enormously beneficial for people, particularly that age group to know. And I think we need to get some of that information out there that, as you said, there's a lot of other misinformation that they're getting. And I think with technology, we have the potential to really scale that up and not just when people enter into treatment, but getting that prevention beforehand. Okay, thank you all for coming. This concludes our symposium, but for anyone else who has additional questions, please feel free to come up afterwards. We'll be here for a few minutes. Thank you.

Technology-Assisted Treatment

Substance Use Disorders

Telehealth

Accessibility

Stigma

Opioid Use Disorder

Buprenorphine Treatment

Digital Therapeutics

Therapeutic Education System

Cultural Alignment

Gender-Specific Care

Patient Engagement

Healthcare Integration