Good afternoon, everybody, and I appreciate Adila, Nusrat, Shahrazad, it's good to see you here. Brian Hurley. I am the president of the American Society of Addiction Medicine, and I'm also an addiction psychiatrist, medical director in the L.A. County Department of Public Health's Division of Substance Abuse Prevention and Control. This is an AMNET webinar about medications for co-occurring opioid use disorder for people in mental health settings, that is, people for whom they're seeking treatment for a mental health condition, and they also have opioid use disorder. This presentation is being brought to you by AMNET. AMNET is a portal-based and measurement-based care tool to help advance the delivery of addiction medicine and addiction psychiatry services, and so we'll be talking more about AMNET in a bit. This is just a little bit about me. Again, medical director, L.A. County Department of Public Health, Substance Abuse Prevention and Control. I'm the clinical director for the Treating Addiction in the Primary Care Safety Unit program funded by California Department of Public Health Services and an outgoing, it's a sun-setting grant, but a co-PI on a TRDRP-funded integration smoking services into community mental health center project. President of ASAM and a member of the AMNET Steering Committee, and I'm on faculty at UCLA. I don't have any financial conflicts of interest to disclose. Let me get that box out of there. Yeah, I don't have any financial conflicts of interest to disclose. As the president of ASAM, I am not unbiased with respect to ASAM, so just full disclosure, there may be topics related to ASAM that come up, and I'm not unbiased with respect to them. And then, oh, I just noticed. One question that comes up as well, I get a copy of the slides, Barbara, I put a link to the slide deck in the chat, but I don't think it is broadcasting, so I'll try to. I'll try and do that again. Yeah, if you could just send that out to everybody, that'd be great. All right, cool. So, learning objectives for the hour we have together. Explain the screening, diagnostic, and response monitoring that are appropriate to identify and treat people with co-occurring opioid use disorder, that is for people in mental health settings with a non-substance mental diagnosis that also have opioid use disorder. There are three FDA-approved molecules that are approved for the indication of opioid use disorder, and they can absolutely be feasibly deployed in mental health settings. And talk about actually setting up an opioid use disorder services program within a mental health clinic. So that's what we have on our agenda. So, I figured I'd actually start at the end. So what are the major features? The take-home points are this. If you are a patient in a mental health program, you get naloxone. If you are somebody in a community health program, you get naloxone. If you're somebody who's not in care, you get naloxone. Everybody gets naloxone. It should be ubiquitous. Naloxone is an opioid reversal agent that, when deployed to somebody early on in their opioid overdose, reverses the overdose. And so, it is an essential medication that, at this point, needs to be widespread because we are in the worst overdose crisis in American history. The way we talk about addiction matters. We use the word opioid use disorder. We don't use terms like addict, clean, dirty, sober, or clean and sober. I hear that all the time. We use medical terminology to refer to medical illnesses, so language matters. One misunderstood thing about addiction treatment. Most people with addiction don't get treatment, so roughly 95% treatment gap, right? I think on the last test, it was like 94% of people with substance use disorders are engaged in substance use disorder treatment within the past year. The reason the vast majority of people who are not in treatment are not in treatment is because they don't want treatment. The biggest bottleneck to treatment is lack of demand, not lack of supply. But the supply of addiction treatment historically takes somebody with a substance use disorder and says, aha, you have a substance use disorder, you have to go somewhere, like go from wherever you are to treatment. And again, that works one in 20 times. But the big push to medications for opioid use disorder in community mental health settings is to try to get treatment to where people are. And that's how we grow. That's how we address the treatment gap is to try to take some of the components of addiction treatment that are currently kind of exist within the specialty SUD system and make them accessible as out of that system, because most people don't actually want or not ready to go to treatment. Now, over the course of people's lives, people's readiness to engage in treatment evolves. The treatment gap is not 95% or it's not like 5% in lifetime, but that is a point prevalence on the treatment gap. And that also means that we need to work with people before they're ready to stop using. And we can start medications for opioid use disorder, at least some of them, before somebody stops using. That we need to offer medications for addiction treatment in general for alcohol and opioid and tobacco use disorder and the off-label meds for stimulant and cannabis and other use disorders. And that's a whole full day on addiction medicine. And this is where my bias comes in, because you can come to the ASAM meeting or the APA meeting or there's other conferences you can go to really get the full how to do addiction medicine. But to offer medications for addiction treatment, particularly for opioid use disorder, as quickly as possible, without necessarily requiring somebody to go to groups or finish a full psychosocial assessment, which is important. We want people to get assessment, but the order, the sequence of things is that people get access to the medications as quickly as possible. And MNET can actually help with all of this. MNET has built in measurement-based tools to help with all of this. All right. So we started at the end, and that's what you're about to hear about all of these things. So real quick, worst overdose crisis in American history. There were more overdoses in 2022 than 2021. Against overdose rates appeared to kind of plateau in the 2017 up through the pandemic and then starting in 2020, we've just seen a rise. The overdose crisis started with prescription opioids, and we've gone through waves of addiction crises in U.S. history. And the overdose crisis really started with prescription opioids in the 1990s. Opioid prescribing interestingly peaked in 2011, and if you look at opioid prescribing since 2011, it's been on the decline. Interestingly though, opioid overdose has been increasing steadily since then. Does anyone know why, if prescription opioids have been on the decline, how come opioid overdose continues to increase? And this is where you can chat this in the chat, or you can pose the answer as a question in the Q&A, however you want to respond. How come, a question to you, how come if opioid prescribing has been on the decline, opioid overdose has continued to increase? Exactly. Thank you, Haral. Yeah. So, fentanyl, fentanyl. This is the comparative, you know, sort of roughly equivalent strengths of heroin, fentanyl, and then like a more potent fentanyl, like carfentanil. There's also su-fentanyl, alpha-fentanyl, there's all these other like fentanyl derivatives that are like super, super potent. So that's right. And actually, the opioid overdose waves happen in, we think of them as happening in three waves, right? Wave one really started in the 1990s, this rise in prescription opiate overdose deaths. Waves two was actually heroin, right? One of the things that did not get as much airplay is, we talked a lot around opiate over-prescribing, but de-prescribing opioids is also a skill. Now, I'm a psychiatrist. I don't generally prescribe a lot of opioids that are not buprenorphine, but I do de-prescribe benzos all the time, right? So for those of you that are psychiatrists or familiar with benzo-prescribing, it's a process to get people off. And I think what happened was, with the increasing attention to the opioid crisis, people just stopped prescribing opioids and left people who had been, you know, treated with prescription opioids for a long time without a source of prescription opioids. And so it was very interesting. You'll look at the green curve that began to go down, like as in 2011, when opioid prescribing went down, then, what's it called? Heroin went up. And I'm probably going to pronounce this wrong, but Shorarozard brought up, yeah, like less prescribing opioids. It led to use of heroin, right? And then it was fentanyl. So this graph exactly explains what you just brought up, which is, yeah, people switched to heroin and then from heroin to fentanyl, and like, and fentanyl has just exploded in terms of exponential increase in overdose deaths. And that's really what we're seeing across the country. All right. Now, roughly half of people with substance use disorders, it's a little bit less, but, you know, it's like 40 plus percent of people with substance use disorders have a co-occurring mental illness. I have, and AMI means any mental illness. So this, again, comes from the 2021 NSDA. So not everyone with a substance use disorder or an opioid use disorder has any mental illness, but roughly half do. And if you look at which proportion of people with serious mental illness have substance use disorders, it's also not quite half, like it's in the, again, 40 percent range of people with serious mental illness have a substance use disorder, right? And people with serious mental illnesses, typically like psychotic disorders, severe depression, severe bipolar, severe anxiety disorders, personality disorders, are typically served within community mental health settings, right? Not necessarily primary care settings, but mental health clinics. So that's really, it's that purple that we're really looking at. It's a substantial portion of people in mental health treatment have co-occurring substance use disorders. And if you look at the range of substance use disorders, tobacco use disorder is overrepresented, alcohol use disorder is overrepresented. You don't necessarily have opioid use disorder is not necessarily the biggest signal in terms of substance use disorders, but you'll notice compared to people with no mental illness, any mental illness and serious mental illness is sort of overrepresented compared to people with no mental illness in terms of prevalence of opioid use disorder. So the point I'm making is that co-occurring substance use and mental health disorders are common. In terms of co-occurring OUD, I worked on a project here in LA that sampled a little over 3,000 clients, and it was like a convenient sample. It was like a waiting room sample. Eight percent of those people had a probable prescription opioid use disorder, and 2 percent had a probable heroin use disorder, which compared to like 1 percent, which is sort of general population, is much higher in community mental health settings than that. But to the point I made earlier, only 6 percent of people with a substance use disorder received treatment for their substance use disorder, and 97.5 percent of this 94 percent, sorry for the fractions of fractions, but of this purple or not purple, of this orange part of the chart, the biggest reason why people don't get treatment is they don't want it. 96.8 percent of people with substance use disorders that don't get treatment don't get treatment because they don't want it. We have a demand bottleneck, not a supply bottleneck. That isn't to say that supply issues are perfect. I work for an addiction treatment setting, you know, or system. You know, 1 percent of people, of the people that didn't get treatment, sought treatment and didn't get it. So it isn't, you know, it is not, we don't have treatment on demand here in the United States. I'm not implying that there aren't access issues. There are access issues, but that's not the biggest reason for the treatment gap. The biggest driver of the treatment gap is lack of demand. So if you have somebody with a co-occurring opioid or other substance use disorder and you're like, ah, I know what to do here. Go to this treatment program. That does not work. 19 out of 20 times, right? Like, like that does not, that people do not successfully land where you refer them most of the time. And so, and that's a, do you need to go to an addiction treatment program for somebody to respond to medications for opioid use disorder? No, actually, interestingly, treatment is effective, right? Medications for opioid use disorder, reduce overdose deaths, increase treatment retention increase function. Like treatment is effective, but it's just, it's underutilized, right? And less than a quarter of those with co-occurring OUD get any treatment for both conditions, right? The idea is like integrated mental health and co-occurring disorder treatment. So there really is just a lack of co-occurring disorder treatment in mental health settings. And part of it is there, there can be wait lists. Medications are not uniformly available. There's oftentimes stigma and logistic barriers. So there are access issues, but I actually think that the biggest issue why people with opioid use disorder don't get treatment is people working in community mental health settings don't feel like it's their job to do it. I'm a mental health clinician. I don't deal with that. I send patients away to another program to deal with that, because that's not my job. It's a, it's a really kind of lack of training, both on the addiction treatment side of working with people with serious mental illness and on the mental side of thinking, ah, this person has an opioid use disorder. I know what to do about it. This siloing, this sort of like treating people like pinballs, let me send you over here. Let me send you over there, is deeply counterproductive. And actually the surgeon general of the United States put out this report called Facing Addiction in America. If we want people with addiction to get treatment, we have to integrate it, right? So here's a quick model on that. So there's addiction treatment settings that usually don't offer meds, typically don't offer meds. There's medical hospitals, primary care clinics, mental health clinics, housing sites, and then medications for addiction treatment services that exist in this kind of like weird, like it's an addiction treatment, but not all addiction treatment programs offer it. Like it sort of exists in this kind of limbo because, you know, no, no one entity seems to own it within the healthcare system. And really the vision, you know, and I say this as an addiction physician, rather than trying to like build up a completely separate addiction system around medications is to get medications integrated, right? Addiction treatment, like meds need to be available in addiction treatment, right? And medical hospitals should offer medications and, you know, frankly, substance use navigations, counseling for addiction treatment and in primary care and in community mental health settings and in housing and social services that link people to medications and counseling and support for their addictions. Okay. So where does AMNET fit into this? So there's a whole list of screening tools. This is the, just a screenshot of the National Institute on Drug Abuse screening tool chart that goes through different substance types and age groups and self-administered versus not. The tool that AMNET uses for kind of screening, like who to go from undifferentiated, I don't know anything about you patient to who am I completing an assessment on. The TAPS is a relatively efficient tool to do this. This is the, I'll go back one, the tobacco alcohol prescription medication and other substance use TAPS form. There is both clinician administered and patient administered versions of this. This is what the clinician administered one looks like, but it's very similar for patient administered, which is past 12 month use of any illicit drugs and past 12 month use of prescription, like controlled prescriptions in any category. So stimulants, sedatives, and opioids. And then for people that yes, said yes to using heroin or other illicit opioids, then you ask, have you tried and failed to control, cut down or stop using heroin or fentanyl or whatever the illicit opioid is. And then the past few months, has anyone expressed your concern around your use of heroin, fentanyl or whatever it is? And then, and past three, the same questions, have you trialed, failed to cut down or stop using an opioid pain reliever and does anyone express concern? This then gets scored and essentially a score, you know, yes to either of these questions indicate somebody needs to be like assessed for addiction. Now there is a definition of addiction. This is from the American society of addiction medicine. Again, as the president of ASM, I have a small conflict of interest, so I'm not unbiased about this definition. I think highly of it, but it is the ASM definition of addiction, which is a treatable chronic medical disease that involves the brain genetics environment and somebody's life experiences. People with addiction use substances or engage in behaviors that become compulsive and often to continue despite harm and prevention and treatment for addiction are generally as successful as those for other chronic illnesses. This is the definition, but what it isn't is a diagnostic criteria. So there is, the APA has these 11 diagnostic criteria, two or more of these indicates a diagnosis of a substance use disorder, two to three is mild, four to five is moderate and six or more severe. Not every clinician has memorized all 11 criteria. So a shorthand is you can group these into the three C's, loss of control, craving tolerance and withdrawal. That's kind of a loose group for C, but, you know, sort of the physiologic cravings and tolerance and withdrawal and consequences. So the three C's of addiction. Now, one thing, it kind of doesn't matter what addiction, you know, what addiction you have. You know, addiction is a chronic illness. Substance use disorder is a sign of like the diagnostic criteria that we use to determine, like to sort of diagnose people with opioid use disorder separate from alcohol use disorder. We think that there's some like final common pathways to addiction, mostly driven by dopamine. And actually there's a lot of pet studies and fMRI studies looking at changes in dopamine that result, whether it's cocaine, meth, alcohol, heroin, sedatives, you know, used to sort of seem to have this final common pathway of a disruption in dopamine neurotransmission. And there's actually like crossover and one of the reasons that we see like 50%, roughly, 50% accordance of serious mental illness and substance use disorders has to do with both the genetic and environmental comorbidities. So there are genetic changes in dopamine receptors, opioid receptors, other neurotransmitters and intracellular signals, and also some genetic component to novelty seeking and harm avoidance and impulsivity and psychiatric disorders, right? So there's like a genetic loading and then the environment, who were you born to? What was your family of origin? What's the family that raised you? Did you have any adverse childhood experiences, any co-occurring psychiatric conditions, stressors, positive experience, and then access, right? Illicit sources of access to illicit opioids or other intoxicants, access to controlled substances through prescription, and then family and friends that might offer access to substance use disorders. I made the point upfront that everyone should get naloxone. I'm not gonna spend a ton of time saying that more other than to say everyone should have access to naloxone, like, and you can distribute it in almost every state, you can prescribe it in every state. The FDA just announced clearance of an over-the-counter version of naloxone, although I don't think it's hit drugstores yet, but bottom line, nobody needs to die of an opioid overdose because we have the tools to reverse opioid overdose. All right, so this is a talk focusing on addiction treatment, right? And the core components of addiction treatment are meds, counseling, and support. I'm gonna talk a lot about the meds, but I don't want that to be interpreted as the counseling and support are irrelevant. Counseling and support I think of as like, we want everyone with addiction to get meds, counseling, and support. All right, now what is the treatment for depression? Meds, counseling, support. What's the treatment for diabetes? Meds, diet, and exercise. This triad of behavioral medicine is not unique to addiction. So we're gonna spend some time talking about the meds, but I want patients to get all three items on the menu, right, meds that handle, you know, our biology and physiology, counseling that also affects our biology, but also our skills and strategies and thought process and the way we manage ourselves and our lives, and support being housing and transportation and food security and safety and, you know, people, places, and things, right? That's support. Now, it just so happens that for opioid use disorder, the medications have an extraordinarily important role because they, you know, even without counseling support, seem to dramatically reduce the risk of overdose. So the way that I think about it is this. It's not that I want, it's not that I think that meds are the treatment for addiction, but, you know, in a typical mental health clinic, you come in, you get an assessment, then you might be scheduled with a prescribing clinician depending on the staffing at some point, in the meantime, like you might be without meds for a while. And I think of like opioid use disorder that has the same mortality as like having a heart attack, is we can't necessarily wait for business as usual, and people need access to medications as soon as we identified opioid use disorder. All right, so what are the meds? Methadone, buprenorphine, and netraxone. Those are the three FDA approved molecules. Now, methadone at this point has been longtime generic and in opioid treatment programs managed in a liquid form that people take in the clinic. Buprenorphine is a med, can go through community pharmacies, and netraxone is either oral or injectable. Injectable seems to work reasonably well for opioid use disorder, the oral does not. And then naloxone, and just nobody needs to die of an opioid overdose because we make sure everyone gets access to naloxone. Naloxone doesn't prevent overdose, it just reverses overdose. It doesn't encourage overdose. So I think it's a rescue med, not a treatment, whereas methadone, buprenorphine, and netraxone are all treatments. I get asked this all the time. Okay, fine, but how long do I need to be on these meds? Like, for example, I could go to an opioid treatment program and they'll give me a three day or two week detox, right? I'll come in and take, you know, a tapered dose and I can comfortably come off or what's called manage my withdrawal. So why not just? Withdrawal manage everybody, right? You have people who they take prescription opioids, they take illicit opioids, they're on fentanyl, they're on heroin, right? They're using opioids. They stop using opioids, they go through withdrawal. So you give them medications to manage their withdrawal, which can usually be completed in a few days to a few weeks for most people. Why not just do that, right? And then they won't be in withdrawal and everything's better. Well, the thing is, withdrawal management does nothing to improve somebody's outcome for their opioid use disorder, interestingly, right? Withdrawal management, while oftentimes necessary if people are gonna stop using opioids, right? So there's a role for withdrawal management. If it's not connected with either putting somebody on medication maintenance or putting somebody in another counseling support maintenance treatment, if it's not associated with some ongoing work to change that dopamine circuit, right? Because the issue with addiction is this dopamine circuit. It's not your opioid receptors. Your receptors are connected to dopamine, but it's this underlying like, well, the definition of addiction, right? The definition of addiction involves the compulsive use of substances. And that's driven by, again, like the brain, genetics, the environment, and an individual's life experiences. And that takes work. As a chronic illness, we need chronic ongoing treatment to address the underlying disease process. And withdrawal management doesn't cut it. The relapse rates following completion of withdrawal management are 100%. If it's not connected to some ongoing work. So withdrawal management, again, can help, but it is not a treatment and people need ongoing care. This point was made in ASAM's national practice guideline for the treatment of opioid use disorder, which actually goes through like the recommended treatment for opioid use disorder is a maintenance treatment. And the first line, it's not required to do meds, but first line really is medications because of their life-saving effect. I'm going to go through these next set of slides quickly because they are the pharmacology slides and they're available in the handout really as a reference. So we have methadone, buprenorphine, and naltrexone. Methadone is a full agonist opioid. It's got a long half-life, but pretty variable. Some people are quick metabolizers. I mean, it's a long half-life in everybody, but it can range from 15 hours, where it lasts your system for a few days, to 60 hours, which it lasts your system for a few weeks. So there are people that there's some variability in the half-life of methadone. And that's why when you have people initiating methadone for opioid use disorder, you observe them taking their doses to make sure that like, if they come up the next day and they look completely narcotized and it's not, you know, sedated and showing signs of opioid toxicity, and it's not because they're using other opioids on top, it's from the methadone you're giving them, then you know to like pause or slow the titration. So there's some rationale to observed dosing for methadone, at least during the initial titration period. It's got a relatively weak affinity for the opioid receptor. That's why we dose methadone in like tens of milligrams, not ones of milligrams. And it does cause respiratory arrest and overdose, and it can cause QT prolongation. So like it's a useful life-saving medication, but it's not risk-free. You can overdose on it and it can affect your heart rhythm. But it seems to work really well. So if you look at methadone treatment efficacy, this is an older study from 97, but you know, regardless of the study you look at, opioid use goes way down. Doesn't oftentimes go to zero, but it goes way down. And interestingly, in the people that, you know, stop using other illicit opioids, they oftentimes slow down their use of other illicit drugs themselves. So this was looking at cocaine. Buprenorphine is different than methadone because it does not have a full agonist effect. It is a partial agonist. It activates the opioid receptor, but to a point. It's got a ceiling effect, right? You get an opiate effect, but you get it to a point. But unlike methadone, it's high affinity. In fact, super high affinity. So it binds the receptor really strongly, but like stronger than other opioids. In fact, it binds stronger than methadone. It binds stronger than fentanyl does, right? It's a very high potency opioid in terms of its strength of binding to the receptor, but it's not a full agonist in the sense that it doesn't activate the receptor fully. So you can't really overdose on buprenorphine or you can't really overdose on buprenorphine on its own. Now, if you combine buprenorphine with other CNS depressants, particularly ones that you're injecting or smoking, like we do see buprenorphine overdose or buprenorphine involved overdoses typically that are stimulant overdoses or sedative overdoses where buprenorphine just happens to be present, but buprenorphine itself does not really seem to have overdose toxicity. It doesn't cause or contribute to overdose. Also along half-life, 24 to 36 hours, it displaces other opioids, but doesn't fully activate the opioid receptor. So you'll notice these pink arrows. These pink arrows reflect that if you take buprenorphine while you're high on another opioid, it will precipitate withdrawal. Not a full withdrawal, but it will precipitate some withdrawal. So this point of, if you take buprenorphine while you're still using other opioids, you can precipitate a bit of withdrawal and that's the trick to prescribing buprenorphine is you instruct somebody, hey, I'm gonna prescribe you buprenorphine. Stop using whatever you're using. Wait until you're in withdrawal. Wait until that green line, for full agonist, wait until that green line is down. You just started to go into some withdrawal, some regular, it takes a few hours to develop kind of withdrawal, then take the buprenorphine and it will alleviate your withdrawal. If on the other hand, you've just taken a dose of heroin or fentanyl or whatever it is, and then you take buprenorphine right after, it will precipitate withdrawal, right? So the timing of when you take buprenorphine is important. It sounds scary for clinicians. It's actually pretty straightforward. And we're now up to, you know, probably, you know, hundreds of thousands of people treated with buprenorphine effectively. So it's not rocket science. It's just a subtle point to the starting of buprenorphine. Now, why would I do buprenorphine versus methadone? So buprenorphine can be accessed through community pharmacy. So I don't have to send my patient to an addiction treatment program. I can prescribe buprenorphine in my community mental health center. And I do send patients to the pharmacy where they're getting their antidepressants, enzealytics, antipsychotics, stabilizers, whatever else I'm prescribing them. And they also get their buprenorphine. They pick it up. I give them instructions on how to take it. They take it. And that's integrated medication care, right? There's not actually, there's not a lot of like extra stuff. Now, what are my targets for buprenorphine? I'm looking at alleviated withdrawal, reduced cravings, improved health and social functioning, and reduction in drug use being desirable, but not required. Like somebody doesn't have to stop using heroin. They can use it on top of their buprenorphine. They shouldn't start buprenorphine while they're high on heroin, but after they started, they can use heroin on top. Buprenorphine blunts their response to heroin. So it's there or oxycodone or fentanyl or whatever it is. But it doesn't, it's not, it won't like re-precipitate withdrawal once they're on it. So abstinence is desirable, but not required. And that they're tolerating it, right? They're not having terrible headaches or nausea or any other side effects. But the biggest reason for low threshold or kind of early initiation of buprenorphine is the effect of buprenorphine on mortality, right? A over four-fold reduction in all-cause mortality because opioid use disorder is a frequently fatal illness. Overdoses happen. There's more overdoses now in U.S. history than ever before. And it reduces overdose mortality by over four-fold. It also increases the chances that people are gonna stay in treatment, right? We see a roughly, at 12 months, 50% treatment retention, which compared to treatment as usual, which is usually like a 10% treatment retention. Huge, right? A much greater chance somebody's gonna continue to show up for care. And over time, a greater proportion of people that are negative for other opioids, like heroin, fentanyl, or illicit opioids or misuse of prescription opioids. Now, there are versions of buprenorphine that are FDA approved for the indication of opioid use disorder. These are them in a nutshell. It's sublingual film or tablets. There's a generic tablet and a brand name tablet called ZubZulb. And there's also a generic film and a brand name film called Budavail. I don't have any conflict of interest. I'm not trying to hawk any particular formulation. There's also a buprenorphine only tablet. So the standard sublingual dosing has naloxone co-formulated with buprenorphine, not because actually it does anything. Like, interestingly, if you put buprenorphine with naloxone under your tongue, the naloxone isn't absorbed because there's poor oral bioavailability, but the buprenorphine is. It's to create a pharmacologic disincentive for people snorting, like crushing and snorting buprenorphine or injecting it. So it essentially is this like anti-diversion tool, whereas buprenorphine only tablets don't have the naloxone in it. So they're easier to crush and snort or inject. Generally speaking, for most of our patients, we use the combination formulation and just instruct people on how to use it, which is put it under the tongue and wait for it to dissolve. It's not an oral medication. You don't swallow it. Oral bioavailability of buprenorphine is also pretty low, but between your tongue and at the bottom of your mouth is the most common place where people find good oral or buccal absorption on the cheek. And there's also a monthly injectable called Supplicate, and there's another injectable, I think, coming to the market soon. So these are the buprenorphine formulations that are FDA approved for opioid use disorder. There are buprenorphine formulations that are FDA approved for pain. There's a patch, there's a short-acting injectable and a buccal film FDA approved for pain. And it remains a violation of the Controlled Substances Act to use buprenorphine formulations FDA approved for pain to treat addiction. It is fully okay to use buprenorphine formulations FDA approved for opioid use disorder off-label for pain, but the federal government has a lot of rules in the Controlled Substances Act over treatments for addiction. So these are the ones, if you're treating opioid use disorder, these are the formulations to stick with. All right, I'm doing so much talking. How many of you have your X waiver? And you can raise your hand, I think, because I have the attendee list pulled up. Thanks for all. Thank you. I'm so sorry. I like to pause every time I do this. Shiraz Azard. Anyone else? The two of you have? So that's actually kind of a trick question because none of us have our X waiver anymore. The X waiver has been eliminated. So those of us that did, don't any longer. The FDA or the DEA has essentially eliminated the X waiver. Like it doesn't exist anymore. All of our X waivers have been like taken away. And in its place, anyone with a DEA registration can now prescribe buprenorphine for OED, right? You don't have to have the separate registration. So now all of us are X waiver. Like the other way to look at it is like all of us are X waiver now. Yeah, thanks, sir. So all of your colleagues that say, oh, I can't prescribe buprenorphine, I'm an X waiver. Well, on one hand, neither am I anymore. On the other hand, we all kind of are because the X waiver got us the ability to prescribe buprenorphine for OED. Now any of us can. Now that said, not every pharmacy is necessarily up to speed on this. I know my prescribing software still has the X waiver number. So, you know, like the systems in which we work oftentimes they'll expect us to have an X waiver and there's still a, I'll call it local unwinding process. So I live in the state of California. My state had no X waiver language in reg except for our Medi-Cal billing or our Medicaid program billing requirements for buprenorphine, which were quickly taken out. So an X waiver is no longer required from California Medicaid to cover buprenorphine. It's now coverable by anyone with a, when you sign up for a DEA registration, you can sign up for schedules two, three, four, and five, I think, and as long as you have schedule three included, you're good. So for those of you that were X waivered, you do not need to take a new DEA course to prescribe bup. There is no course requirements. Anybody can prescribe bup now as long as you have schedule three. So coursework isn't required. What the DEA is doing is if you are not board certified in addiction medicine or addiction psychiatry, and if you did not get X waiver previously, and if you did not graduate from a medical, nursing, physician associate, or like another like health professional school that gave you not less than a year of X waiver, gave you not less than eight hours of training and say prescribing and SUD management, then you will be required to take eight hours of training to get your DEA registration at all, not to prescribe bup, but to renew your DEA registration. DEA registrations are renewed every three years, and this is in effect starting in June. So the, well, conflict of interest, the American Society of Addiction Medicine has a page with all of the CME requirements that are necessary to satisfy the DEA requirement. So does, I'm almost 100% sure psychiatry.org does, so does the American Medical Association, so does PCSS, the Provider Clinical Support System. So there's like multiple, multiple options on where you can go to get your training to renew your DEA registration if you were not otherwise X waivered, in which case you are counted as being in compliance. Or if you are board certified in addiction medicine or psychiatry, or if you are a recent graduate, like within the last five years of 2013, they can attest to having received that as part of your health professional training. So that's, but as we're sitting here talking today, anyone with a regular DEA registration, no training required, is allowed to issue prescriptions for buprenorphine for people with OUD. Okay, let's see. We're 40 minutes in, a little over halfway through the slide, so I might need to pick it up a little bit. I already kind of covered this, which is we put naloxone with the buprenorphine really as an anti-diversion. You know, it decreases IV misuse of it because it precipitates withdrawal because naloxone is active when injected and not active when taken sublingually. And then this is also the ceiling effect. Higher doses of buprenorphine slow, but don't suppress the respiratory rate. So you don't go into respiratory arrest even with like 32 milligrams of buprenorphine, which is pretty high dose. The common side effects of buprenorphine, headaches, nausea, constipation, and dry mouth. And the next slide is the handout I use in my practice, which is how to start buprenorphine. So you wait until you're in withdrawal. You could use a cow scale, and actually our MNET has both a cow's and a sow's scale built in, and I'll go through how to use MNET to measure withdrawal, but essentially any three of these 11 features, sorry, yeah, yeah, any three of these 11 features is enough for people to be in enough withdrawal to tolerate buprenorphine without precipitated withdrawal. There are tablets and films are the most common versions that we use to initiate buprenorphine. I usually give people the option, there's a, you know, you can cut the eight in half and start at four, you can go with eight. I tend to go with higher dose buprenorphine initiation because I work with a population that tends to have higher dose opioid use, so I need to go with higher dose in order to help, but you can also start with two milligrams in people that have, you know, lower opioid tolerance. So questions that I ask, are you interested in blank? And blank is methadone, buprenorphine, or extended release naltrexone injection. Keep in mind, if they say yes to methadone, I have to send them to a OTP, to a federally licensed opiate treatment program, but I will say things like, are you interested in buprenorphine? If that's what I have available to help you stay out of withdrawal, use less and prevent overdose. And I'm pretty intentional. I don't say, are you ready to stop using? Are you ready to go to treatment? Are you ready, like, do you want a med to help you stay out of withdrawal, use less and prevent overdose? That's keywords that I use. There's multiple brand names for medications for opioid use disorder, and the way I describe it, it stops cravings, prevents overdose, and stops withdrawal, but we need to find the right dose. And knowing things like how much does somebody use and the route of use and what other substances does somebody use? Are there any significant medical conditions? What's the best contact number and easiest pharmacy? This all helps with some of the next steps. And every patient I start on buprenorphine asks how long do I need to be on it? The answer is not a day longer than necessary, but for some people it might be their whole lives, right? I'm sure we, how long do I need to be on my mood stabilizer? How long do I need to be on my antidepressant? How long do I need to be on my antipsychotic? It's really individualized. And I get a lot of patients off of buprenorphine, but it's typically patients who've done a lot of counseling and support to be able to get off buprenorphine. And there's no evidence that counseling support seemed to do that, interestingly, in like randomized control trials. So what I'm speaking to is just like clinical experience, which is like I work with people and then we kind of start lowering the dose, and if they're doing okay, then we kind of taper them off. If they're not doing okay, then we go back up, right? It's like any, frankly, like any other med that we use in mental health and psychiatry. And the evidence is continuous treatment is better than a month of buprenorphine and come off, because when you come off buprenorphine, the relapse rates go way up. Just a quick word on naltrexone. I mentioned it comes in an oral version or an injectable version. The oral version doesn't separate from placebo, and this is a meta-analysis looking at trials of oral naltrexone for OUD. Again, it doesn't seem to separate from placebo in treatment as usual. There is some evidence for daily observed dosing that seems to help, but that's not practical for most treatment settings. So again, compare oral naltrexone with placebo, there was no statistically significant difference. There is a statistically significant difference for extended release naltrexone injection. It's just harder to start, because this is a medication that you really do have to detox somebody or manage the withdrawal before you could start it. Typically, I use this treatment for highly motivated patients who are in a treatment program where they're off of opioids. Like that's kind of like, that's the group of patients that I really, you know, am thinking about, is people who are off of opioids that can tolerate an opioid antagonist without it precipitating withdrawal. So this window period of seven, 10 to 14 days, depending on the opioid, is the biggest barrier to initiating naltrexone. Now, you might say, naltrexone, does that cause hepatitis? And yes, oral naltrexone does seem to be associated with medication-induced hepatitis. We don't see that a ton with long-acting injection, although it can happen. What I'd say is, liver monitoring is really only absolutely required, particularly at baseline, if you know that somebody has liver disease. And the benefits of naltrexone can be considerable, particularly for people with alcohol use disorder, where they can stop drinking, but even for opioid use disorder, when you can get a patient on it. And so I would say, it's best practice is don't withhold naltrexone just because you don't have LFTs. We rarely do that for valproate, right? Like, we'll start patients on valproate even without baseline LFTs. I sort of think of, and valproate's more hepatotoxic than naltrexone is. So if you have an opportunity to initiate naltrexone, do it, and just get the LFTs when you can. This is what a butt looks like. And the quadrant naltrexone goes in is quadrant A. And this is what the blood level of naltrexone looks like. And there is actually some research. This is a research study that was published, sublingual buprenorphine versus injectable naltrexone, showing good outcomes for people that were able to get initiated on naltrexone. What the trial also found was, it was harder to get people onto naltrexone because of that window period. And this was a post-release study looking at naltrexone and its effect on return to opioid use for people leaving the trial. I did mention counseling support. There's a number of evidence-based counseling strategies like 12-step facilitation therapy, and CBT, and motivational enhancement therapy, and intensity management, all of which work. But interestingly, the meds seemed to be effective even if the patient didn't get counseling. So the way that I think about it is this. If opioid use is over, meds first, right? What meds first does is keep people out of withdrawal, keep their cravings down, increase the chances they're gonna show up for counseling, and then offer counseling, right? But I don't have to withhold meds just because a patient won't do counseling. So this is the med first model. People with OUE receive meds as quickly as possible prior to lengthy assessments, that we keep meds going as long as the patient benefits. We always offer counseling and support, but we only stop the med if it's making the patient worse. Med first is not med only, right? It just means that we're starting with meds and then layering other services on top as opposed to we're starting with counseling and layering other meds on top. Okay. So co-occurring, so common co-occurring symptoms are depression and anxiety. The treatment principles for co-occurring disorders are integrated treatment. Try to avoid benzos when possible. They oftentimes have a dulling effect on cognition and blunt somebody's response to other forms of therapy, but don't withhold buprenorphine from patients that take benzos. Oral benzos taken as prescribed at appropriate doses and sublingual buprenorphine taken as prescribed at appropriate doses, there's no evidence that increases the risk of overdose. So oral benzos plus sublingual buprenorphine, safe and effective for opioid use disorder. I'd much rather have you on alprazolam and buprenorphine than alprazolam and fentanyl, right? Let me just be clear. But don't start benzos when you can avoid it. And then a couple of other principles, really the idea is we treat opioid use disorder where our patients are. So if our patients are in mental health, we start treatment for buprenorphine right there. A couple of quality metrics you can consider, which is of the people I am seeing, how many have I screened for OUD? And of the people who screened positive, how many of them were diagnosed? And for those that were diagnosed, how many of them have been treated with medications for opioid use disorder? There's a bunch of other quality metrics, but I think of this as like the big ones to show that your clinic is on the right track. And there's a whole toolkit that I contributed to. I'm not the first author on this by any stretch, but this was a toolkit on integrating pharmacotherapy into mental health clinics that I would encourage you to check out the go-through workflows and organizational readiness. And there's a bunch of treatment planning and organizational planning that's part of this. And then just one thing that I get asked all the time, well, can I bill for this? And the answer is yes. There are some states that require a primary mental health diagnosis for people in mental health treatment, which is fine. You just diagnose the schizophrenia, bipolar disorder, major depressive, whatever their mental health condition is, is like the condition that gets listed as the primary diagnosis. And then you would say something like, we're helping somebody with schizophrenia by treating their opioid use disorder. And that treated opioid use disorder then helps somebody with their medication adherence, with their psychosocial functioning, it supports their overall health and wellness. That's typically how I document a treatment plan with a primary diagnosis of not a substance use disorder. And I mentioned language matters. There's a lot of stuff that people have, like reactions and feelings about addiction. And I would just say, we have a really good evidence that these medications are really effective and it does our patients a disservice when we withhold them. So like, I don't believe in methadone, I don't believe in buprenorphine, you hear all this stuff. Like mad is the gold standard. And like, we should be attentive to our implicit biases and avoid terms like substance abuser, overdose addict, alcoholic, like, you know, first and first language, this is a person that uses substances. You know, I don't call it medication assisted treatment, it's called meds or medications for addiction treatment. So like, don't label the folks we have. And there's a whole like curriculum on language matters and on the NIDA webpage. So, okay, where does MNET fit into this? MNET has the TAPS. MNET has the PhenX cigarette smoking and injection drug use screening tool. So this can be a really helpful screening tool. And like, who am I worried about, you know, injecting buprenorphine where I would, you know, want to wait in a combination of buprenorphine and naloxone products versus a buprenorphine only product. There's the brief addiction monitor, which is a tool that you can use to kind of track someone's progress over time. And then the COWS and the SOWS. So the SOWS is a short opiate withdrawal scale that patients can self administer. The COWS is a clinician administered tool. The visual analog scale is like a global, kind of global satisfaction and treatment effectiveness assessment also looks at people's response to treatment. And then the PHQ2 plus one is the kind of mood anxiety screen plus suicidality. So these are all built into MNET that can be helpful. So the PROMIS pain scale is a three item past week pain scale that can be helpful, particularly for people where opioid use disorder co-occurs with pain. Patients can self administer this when they get access to the MNET portal. Same thing with SOWS, right? Patients can self administer this. Clinicians can administer the COWS when they're observing somebody. This is what the BAM looks like. And this is a, it looks at recency and frequency of use. And there's an entire like home initiation of buprenorphine client portal where people can put in the SOWS and then it can help them out of score. Okay, you're in enough withdrawal to take buprenorphine. So like the tool will help you with this. Visual analog scale is a, this gives you an idea of cravings. How much are you craving? And so over time, ideally we're seeing cravings decrease with buprenorphine treatment. And then the client health questionnaire, which is depression. So it's an anhedonia and depression scale plus a suicidality scale to screen for who might need additional mental health support. And then for those that do answer yes to the suicide answer, there's the Columbia Suicide Severity Rating Scale. Now patients with addiction, so like screen, diagnose and treat opioid use disorder with meds, that's like first line. And for people that really like would benefit from more support, there are whole levels of care and addiction treatment. So like hospital care and residential care and day treatment and outpatient care all along these levels. There's a comprehensive psychosocial screening tool called the ASAM criteria that can be used to determine which level of care is appropriate. I have a confidence of interest in promoting the ASAM criteria as the president of ASAM, but just so you know, there is, there are a number of tools, but the ASAM criteria is like one such multidimensional assessment. And the order is again, screen for, diagnose opioid use disorder, initiate meds. MNET has a number of really, really helpful tools that can like be helpful at the, when do I start my buprenorphine? How am I responding over time? Like it's a toolkit of measurement-based care tools that can guide treatment. And then when patients are ready to actually consider full formal treatment, you can use the ASAM criteria or other equivalent psychosocial assessment to guide which level of care a patient would benefit from. All right, I know that went quickly, but I think we have seven minutes left. So I'm going to go through the questions. All right, buprenorphine-only tablet, who is a good candidate? I use buprenorphine monotherapy for patients that for whatever reason aren't doing well on the combination sublingual therapy. Typically it's for patients that they take the sublingual formulation and within like an hour or two of taking it, they begin to have like these subacute withdrawal features. And that makes me think, huh, is this person actually absorbing oral naloxone? Now you'll have patients come in and say, ah, I'm allergic to the buprenorphine with naloxone. I can only take the buprenorphine-only monotherapy. Now, if I'm working in a harm reduction program and it's like buprenorphine monotherapy or bust, I'll probably still pick buprenorphine monotherapy in the service of engagement, right? Because even if they inject it or snort it, the overdose risk will still go down compared to like fentanyl or another opioid. But if working in a treatment program where like I have some leverage and really the goal is like, I have more wraparound services to support somebody, I'll usually say something like, well, okay, like I understand that you've not done well on the injectable or on the combination buprenorphine with naloxone, tell me more about that. And if they are like, well, you know, I have allergic reaction, what is it? Because sublingual naloxone is poorly absorbed. You know, the most credible reaction is somebody that like begins to develop subacute withdrawal features kind of like well after they've started, right? Like every day that they take it, it's like, yeah, I don't feel good for like an hour or two after I take sublingual buprenorphine with naloxone. That's somebody who might transition to buprenorphine monotherapy. We used to also transition all pregnant patients. The idea being that like you want to expose patients who are pregnant to the fewest number of molecules possible, but actually buprenorphine with naloxone has been validated as just as safe in pregnancy as buprenorphine monotherapy. So I kind of default to buprenorphine with naloxone unless it's not working for whatever reason. What I don't do is like, if somebody says I want buprenorphine monotherapy or not at all, I don't capitulate to that unless, again, unless I'm working in like a harm reduction program where that really is going to be the only option to engage somebody. Okay, so diversion is high in a community with $40 in the area where you live, five, seven years, all pregnant people. You said to continue. I don't know that I fully understand to continue, but I'll continue to read on. You moved to Minnesota, half the practice was on kepapentin, close to that on buprenorphine only because of quote an allergy. Yeah, that sounds to me like the community has been taught that if they say they have an allergy to naloxone, the clinician will just transition them to monotherapy. Allergies to combination products is vanishingly low. So I'll put it this way, it is up to you if you want to fight the battle of transitioning people from monotherapy to combination therapy. If people are doing well, right, they're showing up to clinic, they're peeing positive for buprenorphine, you know, their urine is negative for other intoxicants, like then there's, even if it's the monotherapy, I wouldn't necessarily adjust the treatment plan. If somebody is selling all of their buprenorphine and not taking it and not benefiting, then at that point, I'm not going to continue it because they're not benefiting from it. But if a patient's responding, even with the monotherapy, it's okay to continue. Okay, and happy to, if I didn't answer that right, or if there's more detail, feel free to chime in. Haral says subjective or short. So the SOWS scale, I think it's, what was written on the slide was short opioid withdrawal scale. I think it might also be called the subjective opioid withdrawal scale. At any rate, the SOWS is patient administered, the COWS is clinician administered. And if I got the name wrong, apologies. What do I think the barriers are providing OUD treatment in mental health clinics? Culture. Mental health clinics don't see it as their job. And, you know, we used to have an X waiver requirement. That was kind of annoying. We don't have that anymore. That's no longer a reason not to prescribe, but that was a reason. But I think organizational readiness, surely people just don't see it as their job as the biggest barrier. Because at this point, X waiver's gone. Anyone can prescribe. Like we have the tools in community mental health settings to do this well. It's just kind of clinical culture and organizational readiness, I think are the biggest barriers. Yeah, and case by case, that's exactly right. Like if someone's doing well on their treatment, I don't force a shift out of theoretical, you know, because the combination product is better. They're both buprenorphine. If someone's doing well, it's fine. All right. Anything else before we wrap up? What impact do I think lifting the waiver is needed to prescribe buprenorphine on expanding access to buprenorphine treatment in mental health settings? I think it will help. So the way that I think about it is in order to set up a buprenorphine program, and I'm gonna shamelessly plug the integrating pharmacotherapy for substance use disorders in mental health clinic, you really have to like get everyone in the clinic together. Yes, we're treating RUD with meds and like the front desk staff knows that and security guards know that. There's this whole like set of organizational readiness interventions to like get the clinic ready to treat opioid use disorder with meds. Like it's not a secret. Everyone knows that this is what's happening. The prescribing clinicians are on board. The non-prescribing clinicians know. The counselor, like literally like the clinic gets it. And then, you know, do you have, you know, is an order set in the EHR for urines? Because getting urines is a good practice. It's not required, required, but you know, it's a good practice. And, you know, do you have all of like stuff set up to do it? Not having to do an X waiver helps, right? But in other words, like it removed one barrier, but it didn't necessarily like remove all the barriers, right? So there's like one fewer hurdle and that's good. It's a good hurdle to be gone. But I don't think it's, what I don't think is there's an army of people just ready and waiting to treat opioid use disorder with buprenorphine. And now that the waiver is gone, they're like in a rush to do it. I think of this as like, okay, it's even easier. Now it's even easier, but it doesn't, you still have to do the organizational readiness work to get it to actually go well in the clinic. All right, I think I'm at time. Thank you, Dr. Hurley. And thank you all for attending today. If you have any follow-up questions, feel free to email us at mnetatpsych.org. We can provide you with a copy of the slides. They're in the chat currently, if you want to download them from the Google Drive. And thank you again, Dr. Hurley. It was a wonderful presentation. Thank you. Thank you.

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