Factors Affecting Initiation and Retention of Medication-Assisted Recovery (MAR) within a Pilot Pharmacist-Involved Practice Model at a Federally Qualified Healthcare Center (FQHC) during the COVID-19 Pandemic.

BACKGROUND: During the COVID-19 pandemic, opioid-related overdose deaths increased. Although Medication-Assisted Treatment or Recovery (MAT or MAR) is available, initiation and retention rates vary. The goal of this study was to evaluate clinical, demographic, and Social Determinant of Health factors affecting MAR initiation, on-time initiation of medications, and successful retention in the program. The secondary goal was to evaluate the impact of a novel interprofessional practice model incorporating pharmacists. METHODS: A retrospective analysis was conducted using electronic health record data from a pilot MAR Program initiated within a California Federally Qualified Healthcare Center. RESULTS: From September 2019 to August 2020, 48 patients enrolled into the program. On-time initiation of medications occurred in 68% of patients and average program retention was 96.4 ± 95.8 days. Patients currently using opioids (p = 0.005) and those receiving supportive medications (p = 0.049) had lower odds of on-time MAR initiation. There were no statistically significant factors associated with successful retention in the program. The number of visits with members of the interprofessional team did not significantly affect on-time initiation or successful retention. CONCLUSIONS: Current opioid use and receipt of supportive medications were associated with lower on-time medication initiation. Further studies are warranted to explore additional factors which may affect initiation and retention.

A Descriptive Study on Opioid Misuse Prevalence and Office-Based Buprenorphine Access in Ohio Prior to the Removal of the Drug Addiction Treatment Act of 2000 Waiver.

Background Medications for the treatment of opioid use disorder (MOUD) are effective evidence-based strategies to reduce opioid overdose deaths. Strategies to optimize MOUD availability and uptake are needed. Objective We aim to describe the spatial relationship between the estimated prevalence of opioid misuse and office-based buprenorphine access in the state of Ohio prior to the removal of the Drug Addiction Treatment Act of 2000 (DATA 2000) waiver requirement. Methods We conducted a descriptive ecological study of county-level (N=88) opioid misuse prevalence and office-based buprenorphine prescribing access in Ohio in 2018. Counties were categorized into urban (with and without a major metropolitan area) and rural. The county-level prevalence estimates of opioid misuse per 100,000 were derived from integrated abundance modeling. Utilizing data from the Ohio Department of Mental Health and Addiction Services, as well as the state's Physician Drug Monitoring Program (PDMP), buprenorphine access per 100,000 was estimated by the number of patients in each county that could be served by office-based buprenorphine (prescribing capacity) and the number of patients served by office-based buprenorphine (prescribing frequency) for opioid use disorder. The ratios of opioid misuse prevalence to both prescribing capacity and frequency were calculated by county and mapped. Results Less than half of the 1,828 waivered providers in the state of Ohio in 2018 were prescribing buprenorphine, and 25% of counties had no buprenorphine access. The median estimated opioid misuse prevalence and buprenorphine prescribing capacity per 100,000 were highest in urban counties, particularly those with a major metropolitan area. Although the median estimated opioid misuse prevalence was lower in rural counties, all counties in the highest quartile of estimated misuse prevalence were rural. In addition, the median buprenorphine prescribing frequency was highest in rural counties. While the ratio of opioid misuse prevalence to buprenorphine prescribing capacity was lowest in urban counties, the ratio of opioid misuse prevalence to buprenorphine prescribing frequency was lowest in rural counties. Opioid misuse prevalence and buprenorphine prescribing frequency demonstrated similar spatial patterns, with highest levels in the southern and eastern portions of the state, while office-based buprenorphine prescribing capacity did not. Conclusion Urban counties had higher buprenorphine capacity relative to their burden of opioid misuse; however, access was limited by buprenorphine prescribing frequency. In contrast, in rural counties, a minimal gap was evident between prescribing capacity and frequency, suggesting that buprenorphine prescribing capacity was the major factor limiting access. While the recent deregulation of buprenorphine prescribing should help improve buprenorphine access, future research should investigate whether deregulation similarly impacts buprenorphine prescribing capacity and buprenorphine prescribing frequency.

Deimplementation in the provision of opioid agonist treatment to achieve equity of care for people engaged in treatment: a qualitative study.

BACKGROUND: Deimplementation, the removal or reduction of potentially hazardous approaches to care, is key to progressing social equity in health. While the benefits of opioid agonist treatment (OAT) are well-evidenced, wide variability in the provision of treatment attenuates positive outcomes. During the COVID-19 pandemic, OAT services deimplemented aspects of provision which had long been central to treatment in Australia; supervised dosing, urine drug screening, and frequent in-person attendance for review. This analysis explored how providers considered social inequity in health of patients in the deimplementation of restrictive OAT provision during the COVID-19 pandemic. METHODS: Between August and December 2020, semi-structured interviews were conducted with 29 OAT providers in Australia. Codes relating to the social determinants of client retention in OAT were clustered according to how providers considered deimplementation in relation to social inequities. Normalisation Process Theory was then used to analyse the clusters in relation to how providers understood their work during the COVID-19 pandemic as responding to systemic issues that condition OAT access. RESULTS: We explored four overarching themes based on constructs from Normalisation Process Theory: adaptive execution, cognitive participation, normative restructuring, and sustainment. Accounts of adaptive execution demonstrated tensions between providers' conceptions of equity and patient autonomy. Cognitive participation and normative restructuring were integral to the workability of rapid and drastic changes within the OAT services. Key transformative actors included communities of practice and "thought leaders" who had long supported deimplementation for more humane care. At this early stage of the pandemic, providers had already begun to consider how this period could inform sustainment of deimplementation. When considering a future, post-pandemic period, several providers expressed discomfort at operating with "evidence-enough" and called for narrowly defined types of data on adverse events (e.g. overdose) and expert consensus on takeaway doses. CONCLUSIONS: The possibilities for achieving social equity in health are limited by the divergent treatment goals of providers and people receiving OAT. Sustained and equitable deimplementation of obtrusive aspects of OAT provision require co-created treatment goals, patient-centred monitoring and evaluation, and access to a supportive community of practice for providers.

Low Barrier Tele-Buprenorphine in the Time of COVID-19: A Case Report

Background: To reduce the spread of coronavirus disease 2019 (COVID-19), many substance use disorder treatment programs have transitioned to telemedicine. Emergency regulatory changes allow buprenorphine initiation without an in-person visit. We describe the use of videoconferencing for buprenorphine initiation combined with street outreach to engage 2 patients experiencing homelessness with severe opioid use disorder (OUD). Case Presentation: Patient 1 was a 30-year-old man with severe OUD who had relapsed to injection heroin/fentanyl after incarceration. A community drop-in center outreach harm reduction specialist facilitated a videoconference with an addiction specialist at an OUD bridge clinic. The patient completed a community buprenorphine/naloxone initiation and self-titrated to his prior dose, 8/2 mg twice daily. One week later, he reconnected with the outreach team for a follow-up videoconference visit. Patient 2, a 36-year-old man with severe OUD, connected to the addiction specialist via a syringe service program harm reduction specialist. He had been trying to connect to a community buprenorphine/naloxone provider, but access was limited due to COVID-19, so he was using diverted buprenorphine/naloxone to reduce opioid use. He was restarted on his previous dose of 12/3 mg daily which was continued via phone follow-up 16 days later. Conclusion(s): COVID-19-related regulatory changes allow buprenorphine initiation via telemedicine. We describe 2 cases where telemedicine was combined with street outreach to connect patients experiencing homelessness with OUD to treatment. These cases highlight an important opportunity to provide access to life-saving OUD treatment for vulnerable patients in the setting of a pandemic that mandates reduced face-to-face clinical interactions.Copyright © 2020 Lippincott Williams and Wilkins. All rights reserved.

Impacts of the COVID-19 pandemic on enrollment in medications for opioid use disorder (MOUD) in Vancouver, Canada: An interrupted time series analysis.

BACKGROUND: In anticipation of COVID-19 related disruptions to opioid use disorder (OUD) care, new provincial and federal guidance for the management of OUD and risk mitigation guidance (RMG) for prescription of pharmaceutical opioids were introduced in British Columbia, Canada, in March 2020. This study evaluated the combined impacts of the COVID-19 pandemic and counteracting OUD policies on enrollment in medications for OUD (MOUD). METHODS: Using data from three cohorts of people with presumed OUD in Vancouver, we conducted an interrupted time series analysis to estimate the combined effects impact of the COVID-19 pandemic and counteracting OUD policies on the prevalence of enrollment in MOUD overall, as well as in individual MOUDs (methadone, buprenorphine/naloxone, slow-release oral morphine) between November 2018 and November 2021, controlling for pre-existing trends. In sub-analysis we considered RMG opioids together with MOUD. RESULTS: We included 760 participants with presumed OUD. In the post-COVID-19 period, MOUD and slow-release oral morphine prevalence rates showed an estimated immediate increase in level (+7.6%, 95% CI: 0.6%, 14.6% and 1.8%, 95% CI: 0.3%, 3.3%, respectively), followed by a decline in the monthly trend (-0.8% per month, 95% CI: -1.4%, -0.2% and -0.2% per month, 95% CI: -0.4, -0.1, respectively). There were no significant changes in the prevalence trends of enrollment in methadone, buprenorphine/naloxone, or when RMG opioids were considered together with MOUD. CONCLUSIONS: Despite immediate improvements in MOUD enrollment in the post-COVID-19 period, this beneficial trend reversed over time. RMG opioids appeared to have provided additional benefits to sustain retention in OUD care.

Substance Use Disorder Treatment in the Age of COVID-19: Challenges, Responses, and Lessons for the Future

Measures to control the spread of COVID-19 infections, such as restrictions on movement, social distancing regulations, lockdowns, and curfews, are being applied intermittently around the globe. The application of these control measures has had far-reaching effects on the health of patients with Substance Use Disorder and how services and treatment are being provided to them. In the first part of this chapter, we focus on the health and contextual effects of COVID-19 on people with Substance Use Disorder. We then present current evidence of the effects of COVID-19 on Substance Use Disorder treatment services and providers. Studies from around the globe suggest that COVID-19 has increased the vulnerability and stigma toward people who use drugs and substantially decreased their ability to access needed treatment. The second part of this chapter discusses future models for service provision and their possible benefit to Substance Use Disorder patients, emphasizing the use of telemedicine, e-prescribing, dosing flexibility, take-home medicine, and reach-out initiatives. We suggest that models of care based on remote patient management might benefit some patients, but their universal adoption with insufficient evidence could be detrimental to others needing closer clinical supervision. Using hybrid models, incorporating both person-to-person and remote treatment delivery, changing reimbursement schemes, and using new technologies may increase the benefits of remote patient care. © Springer Nature Switzerland AG 2022.

Optimizing Medication Treatment of Opioid Use Disorder During COVID-19 (SARS-CoV-2)

The COVID-19 health crisis joined, rather than supplanted, the opioid crisis as the most acutely pressing threats to US public health. In the setting of COVID-19, opioid use disorder treatment paradigms are being disrupted, including the fact that methadone clinics are scrambling to give "take-home"doses where they would typically not. The rapid transition away from in-person examination, dosing and group therapy in an era of social isolation calls for adjustments to clinical practice, including emphasizing patient-provider communication, favoring new inductees on buprenorphine and leveraging technology to optimize safety of medication treatment. Copyright © 2020 American Society of Addiction Medicine.

Expanding Access to Opioid Use Disorder Treatment Via Telehealth in Lewis County, Washington

Purpose of Study Lewis County is in southwest Washington state. With a population per square mile of 31.4, Lewis County is more rural than the rest of the state (101.2 per square mile). Citizens of the county, as well as health care workers at Chehalis Family Medicine (located in Lewis County), report concerns over rates of opioid use disorder. While Lewis County's age adjusted rate per 100,000 of deaths due to opioid overdose from 2014-2017 was lower than that of Washington state (7.6 vs 9.3), its rate of opioid related hospitalizations was significantly higher (110.7 vs 81.5). Methods Used An asset-based approach was used to learn how Lewis County has been addressing opioid use disorder amongst its citizens. Interviews with health care providers, patients at Chehalis Family Medicine, and the pastor of a local church were performed. These conversations revealed a lack of access to public transportation creates a major barrier to receiving opioid use disorder treatment. A literature review of interventions implemented in rural areas to deliver medically assisted opioid use disorder treatment was performed. Summary of Results The recent use of telemedicine to deliver suboxone treatment at Chehalis Family Medicine has increased access to medically assisted treatment of opioid use disorder. Telemedicine has become more prevalent with some loosening of governmental regulations due to the COVID-19 pandemic. Based upon articles by Guille et al and Weintraub et al, administration of medically assisted opioid use disorder treatment via telehealth offers a means to expand access to care in rural communities. They demonstrated no significant differences in patient outcomes. Implementation of telemedicine at other suboxone clinics in Lewis County would improve access to suboxone treatment. Conclusions A strength-based framework allows the existing assets in Lewis County to be appraised so future work can build upon what has already proved effective for the community. Regarding opioid use disorder treatment, Lewis county has several low barrier suboxone clinics which could increase access for rural patients through implementation of telemedicine. Chehalis Family Medicine's recent success with telemedicine in suboxone treatment could serve as a template for how to do so effectively.

Opioid Policy Changes During the COVID-19 Pandemic - and Beyond

The United States is currently in the midst of 2 public health emergencies: COVID-19 and the ongoing opioid crisis. In an attempt to reduce preventable harm to individuals with opioid use disorder (OUD), federal, state, and local governments have temporarily modified law and policy to increase access to OUD treatment and divert some individuals at high risk away from the correctional system. In this Commentary, we briefly describe how people with OUD are at increased risk for COVID-19, discuss existing policy barriers to evidence-based prevention and treatment for individuals with OUD, explain the temporary rollbacks of those barriers, and argue that these changes should be made permanent. We also suggest several additional steps that federal and state governments can urgently take to reduce barriers to care for individuals with OUD, both during the current crisis and beyond. Copyright © 2020 American Society of Addiction Medicine.

Advancing emergency department-initiated buprenorphine.

Opioids are the main driver of drug overdose deaths in the United States, and there has been a marked increase in opioid-related overdoses during the COVID-19 public health emergency. Many emergency departments (EDs) across the country are implementing ED-initiated buprenorphine programs, and this is a method to address and prevent opioid overdoses. Resources are available to overcome barriers and take action.

Conference Proceedings 33rd AAAP Annual Meeting and Scientific Symposium

The proceedings contain 20 papers. The topics discussed include: the effect of specialty addiction consultation on prescribing medication for opioid use disorder (MOUD) during general hospital admission;mindfulness-based interventions for adolescent drug and alcohol use: a systematic review and meta-analysis;early changes in irritability predict longer-term abstinence from drug use in adults with stimulant use disorder: findings from the stride study;carfentanil, a highly potent opioid responding to high doses of naloxone, what can help?;an inpatient protocol for managing methamphetamine withdrawal;COVID-19 treatment outcome in a cohort of methamphetamine and cannabis users;the impact of COVID-19 on overdose risk and healthcare-seeking behaviors among hospitalized patients with opioid use disorder;and inpatient low dose transitions from full agonist opioids including methadone onto long-acting depot buprenorphine: case series from a multicenter clinical trial.

Outcomes of a mobile medical unit for low-threshold buprenorphine access targeting opioid overdose hot spots in Chicago.

INTRODUCTION: Opioid overdoses in Chicago are unevenly distributed, affecting medically underserved neighborhoods most acutely. Innovations in reaching patients perceived to be hard-to-reach (e.g., unstably housed, marginalized), especially in these underserved neighborhoods, are urgently needed to combat the overdose crisis. This study characterizes the pilot year of a mobile medical unit partnership between a large urban academic center and a community-based harm reduction organization in Chicago. METHODS: This is a retrospective cohort study of all patients who were seen on a mobile medical unit focused on providing low-threshold buprenorphine and primary care in areas with high opioid overdose rates on Chicago's West Side. Treatment episodes were accrued between July 1, 2021, and June 30, 2022 in the first year of operation. The main outcomes were number of patients seen, demographic characteristics of patients, and reason(s) for visit over time. RESULTS: The study saw 587 unique patients on the mobile medical unit between July 1, 2021, and June 30, 2022. Approximately 64.6 % were African American, and more than half lacked active insurance or could not confirm insurance status at the time of visit. The most common reason for initial visit was COVID-19 vaccination (42.4 %), and the most common reason for follow-up visit was buprenorphine treatment (51.0 %). Eleven patients initially presented for other health concerns and later returned to initiate buprenorphine. CONCLUSIONS: The mobile medical unit successfully reached nearly 600 patients in traditionally medically underserved Chicago neighborhoods with the highest overdose rates. The mobile unit's integrated approach met a variety of health needs, including buprenorphine initiation, with a unique opportunity for postoverdose initiation. Several patients initiated buprenorphine after presenting for different health concerns, showing the potential of an integrated approach to build on past mobile outreach programs and reach people with opioid use disorder who are not yet ready to initiate treatment.

Changes in buprenorphine visits in frontier and remote locations: Effects of the SARS-CoV-2 pandemic.

Background: The pandemic has changed many aspects of healthcare, including the treatment of people with opioid use disorder with buprenorphine. Prior to the pandemic, rural health disparities existed in the accessibility of this treatment. Rural and frontier areas of the United States, particularly the Great Plains, had few or no providers of this evidence-based treatment. This study aimed to investigate how access to buprenorphine changed in the Great Plains during the pandemic. Methods: This retrospective observational study compared the number of weekly patient appointments resulting in a buprenorphine prescription for 55 weeks before the start of the SARS-CoV-2 pandemic and 55 weeks after. Electronic health records of the largest rural health provider in the Great Plains were queried. Patients were categorized as coming from a frontier location or a non-frontier location based on the home address provided at the visit. The USDA defines frontier as communities that are small and distant from urban centers. Time series analysis was utilized to understand changes in weekly visits during this period. Results: A significant increase in weekly buprenorphine visits occurred after the pandemic's start. Further, females and people from frontier locations had significantly higher numbers of buprenorphine visits. Conclusions: In an area of the country with low pre-existing access to buprenorphine treatment for opioid use disorder, increases in buprenorphine visits were found after the pandemic began. This was particularly true of females who reside in frontier areas. Pandemic-related changes may have reduced barriers to this critical treatment, especially among rural populations.

Interrupted Time Series Analysis: Patient Characteristics and Rates of Opioid-Use-Disorder-Related Emergency Department Visits in the Los Angeles County Public Hospital System during COVID-19.

The COVID-19 pandemic led to disruptions in care for vulnerable patients, in particular patients with opioid use disorder (OUD). We aimed to examine OUD-related ED visits before and during the COVID-19 pandemic and determine if patient characteristics for OUD-related ED visits changed in the context of the pandemic. We examined all visits to the three public safety net hospital EDs in Los Angeles County from April 2019 to February 2021. We performed interrupted time series analyses examining OUD-related ED visits from Period 1, April 2019 to February 2020, compared with Period 2, April 2020 to February 2021, by race/ethnicity and payor group. We considered OUD-related ED visits as those which included any of the following: discharge diagnosis related to OUD, patients administered buprenorphine or naloxone while in the ED, and visits where a patient was prescribed buprenorphine or naloxone on discharge. There were 5919 OUD-related ED visits in the sample. OUD-related visits increased by 4.43 (2.82-6.03) per 1000 encounters from the pre-COVID period (9.47 per 1000 in February 2020) to the COVID period (13.90 per 1000 in April 2020). This represented an increase of 0.41/1000 by white patients, 0.92/1000 by black patients, and 1.83/1000 by Hispanic patients. We found increases in OUD-related ED visits among patients with Medicaid managed care of 2.23/1000 and in LA County safety net patients by 3.95/1000 ED visits. OUD-related ED visits increased during the first year of the COVID pandemic. These increases were significant among black, white, and Hispanic patients, patients with Medicaid managed care, and LA County Safety net patients. These data suggest public emergency departments served as a stopgap for patients suffering from OUD in Los Angeles County during the pandemic and can be utilized to guide preventative interventions in vulnerable populations.

The Overdose Conundrum

The article discusses the impact of patients' overdose on psychiatrists. It discusses the case of a 45-year-old woman with an opioid addiction and anxiety who was enrolled in an addictions treatment program. Topics covered include how the psychiatrists cope with patient suicide or overdose, how to promote honesty about recurrence of substance use and how psychiatrists can find the right balance in setting boundaries.

The Promise and Challenges of Integrating Real-World Evidence in Clinical Research

The role of real-world evidence (RWE) in regulatory, drug development, and healthcare decision-making is rapidly expanding. While RWE cannot substitute the evidence obtained from randomized controlled studies (RCTs), the two can be viewed as complementary sources with the same goal of understanding and improving patient's outcomes. However, the hopes of RWE have been tempered by several critical aspects/ challenges such as quality of data sources, potential for systematic bias, or formulating a research question using causal inference framework. In this session, we will discuss commonly encountered issues and recommend key methodological considerations and potential solutions for (1) assessing representativeness and generalizing results from experimental to non-experimental studies, (2) identifying under-represented groups in clinical trials for pharmacotherapy for opioid use disorder, (3) characterizing and increasing diversity in clinical trials, and (4) assessing biases and constructing valid ''synthetic control'' arms for (oncology) clinical trials. Each speaker will have 15-20 min each, followed by a 10-min discussion. Additional Q&A time will be allocated at the end of the session. The individual s are described in more detail below. (1) Ben Ackerman;Title: Using real-world data to assess representativeness and improve generalizations of study findings Randomized trials are considered the gold standard for estimating causal effects. Trial findings are often used to inform policy and programming efforts, yet their results may not generalize well to a relevant target population if the trial sample is not representative of the population of interest. More specifically, generalizations will be hindered if a trial is not similar to the population with respect to characteristics that moderate the treatment effect. Statistical methods have been developed to assess representativeness and improve generalizability by combining trials with data from non-experimental studies. Real-world datasets derived from electronic health records are promising resources that can supplement trial data when applying such methods. However, identifying the right real-world data source with the appropriate characteristics captured can be challenging in practice. In this talk, we will articulate a framework for combining trial and real-world data to assess representativeness and ultimately addressing concerns of generalizability. Through this framework, we will provide guidance on defining the target population of interest, identifying a suitable real-world data source describing that population, harmonizing across the data sources, and drawing meaningful comparisons between the trial and target population. This work will provide researchers with methods and tools to contextualize trial findings within the target population of interest through the use of real-world data. (2) Kara Rudolph;Title: Characterizing subgroups that are under-represented in clinical trials for pharmacotherapy for opioid use disorder The opioid epidemic in the United States is a public health emergency, exacerbated by the Covid-19 pandemic. Medications for opioid use disorder (MOUD)- injection naltrexone, buprenorphine, and methadone- are the most effective tools for improving outcomes and preventing overdose among persons with opioid use disorder (OUD), but engagement in MOUD, especially long-term engagement typically required for a successful outcome, is unacceptably low. Long-term engagement rates tend to be even lower in real-world settings-what National Institute on Drug Abuse (NIDA) has termed the research-to-practice gap. This discrepancy between trial and real-world MOUD effectiveness could be partially attributable to differences between clinical trial and real-world population characteristics (e.g. in terms of psychiatric and substance use comorbidities, previous treatment experience, and immigration status) if treatment effects are modified (increased/decreased) by some of these characteristics that also relate to trial participation. We identif and characterize clinically meaningful, interpretable subgroups of persons seeking OUD treatment in US usualcare settings who are not represented or underrepresented in MOUD trials based on multiple characteristics simultaneously. This moves us beyond existing approaches for assessing representation that have generally been limited to considering one individual-level characteristic at a time (e.g. race/ethnicity). (3) Madison Stoms;Title: Minority representation in clinical trials: generalizing trial results to diverse populations Since its origin, medical research has persistently lacked minority representation. In 2020 alone, the US Food and Drug Administration (FDA) reported that a mere 6% and 11% of clinical trial participants report Black and Hispanic race, respectively. Along with efforts to directly increase representation, via revised recruitment strategies, methods are being developed to leverage external data containing information on under-represented populations. The field from which these methods arise, real-world evidence (RWE), is rapidly emerging and aims to address clinical questions outside the scope of clinical trials. In this talk, we focus on generalizability and transportability methods, which can be used to extrapolate results from mostly racially homogeneous samples to diverse populations. We will also discuss the current state of diversity in clinical trials, important assumptions of generalizability and transportability methods, and applications relevant to increasing racial/ethnic representation. (4) Elizabeth Garrett-Mayer;Title: Leveraging RWD for new indications for FDA-approved anticancer agents: are we there yet? Vast amounts of health outcome data are available in real-world datasets (RWDs), like electronic health record databases and medical claim databases. In rare disease settings, performing randomized trials may be resource-intensive and inefficient due to accrual challenges. Efforts have been made to derive ''control arms'' from RWDs, representing a standard of care treatment arm, so all (or most) patients prospectively enrolled in a trial can be assigned to an experimental arm. Major challenges exist in ensuring that comparisons between the arms are meaningful, valid, and unbiased. This talk will discuss challenges, including potential for biases, harmonizing outcome measures, and efforts moving forward that will facilitate supplementing clinical trial data with RWD.

The Virtues of Osteopathic Manipulative Treatments in Patients with Opioid Use Disorder

As America continues to face the opioid epidemic, numerous people have made great strides in receiving formal treatment for their opioid use disorder (OUD). This research seeks to examine the effects of providing osteopathic manipulative treatment (OMT) along with traditional OUD pharmacological methods in providing results for patients. By using prior research on OMT techniques, we were able to uncover how effective OMT can be in reducing the time and discomfort associated with seeking opioid recovery. Osteopathic manipulative treatment, in combination with traditional pharmacology, was associated with reduction of somatic pain, higher success with medication-assisted treatment and lower costs. This research also highlights the importance of OMT in the era of COVID-19 social distancing, as well as special considerations when treating those with trauma histories associated with their disorder. We argue the benefit of OMT in combination with pharmacological methods can be successful at reducing the overall burden of prior OUDs.Copyright © 2023 by the American College of Osteopathic Family Physicians. All rights reserved.

Telehealth for opioid use disorder: retention as a function of demographics and rurality.

Background: Despite lifesaving medications such as buprenorphine and methadone, the majority of individuals with opioid use disorder (OUD) face access barriers to evidence-based treatment. COVID-19 era regulatory reforms have shown that telehealth can improve access to care, although disparities in clinical outcomes are likely to persist.Objective: We aimed to analyze 180-day and 365-day retention in treatment with buprenorphine for OUD overall and by demographics, hypothesizing that retention would be lower among racial/ethnic minorities and rural patients.Methods: We analyzed data from a cohort of individuals with OUD enrolled in treatment from April 1, 2020 to September 30, 2021, in Pennsylvania and New York using a virtual-first telehealth OUD treatment platform to assess rates of 180-day and 365-day retention. Associations between demographic characteristics and retention were assessed using unadjusted and adjusted logistic regression models.Results: Among 1,378 patients (58.8% male), 180-day retention was 56.4%, and 365-day retention was 48.3%. Adjusted analyses found that only an association between older age and greater odds of 180-day retention was significant (aOR for patients aged 30-50 vs. <30: 1.83 [1.37-2.45]). There were no significant associations between sex, race/ethnicity, state, or rurality with retention.Conclusion: While we were unable to control for socioeconomic variables, we found retention within telehealth services for buprenorphine was high irrespective of geography or race/ethnicity, but disparities with age indicate a subset of patients who may benefit from more intensive services early in care.

Predictors of opioid overdose during the COVID-19 pandemic: The role of relapse, treatment access and nonprescribed buprenorphine/naloxone.

INTRODUCTION: Emerging data indicate a disproportionate increase in overdose deaths since the onset of COVID-19. Speculation about causes for the increase center on rising drug use, illicit drug supply changes, and reduced treatment access. Possible overdose mitigation factors include reduced federal MOUD prescribing restrictions, naloxone distribution programs, and increased use of telehealth. Similarly, nonprescribed buprenorphine (NPB) use, increasingly described as a harm reduction strategy in the absence of treatment, may have moderated overdose risk. This study explored factors associated with pandemic-related overdose in people who use opioids (PWUO) in New Jersey. METHODS: We surveyed 342 PWUO from March to May 2021. Approximately 50 % of our sample was treated at some time since the COVID-19 emergency declaration in March 2020. The risk and protective factors associated with overdose were identified using Pearson's chi square test and ANOVA and tested in a series of multivariable logistic regression models for the full sample and the subsample of PWUO treated during the pandemic. RESULTS: Forty-eight percent of respondents increased their drug use during the pandemic, including 32 % who relapsed after previous abstinence. Fifteen percent overdosed at least once since March 2020. In the full sample, overdose was associated with Hispanic ethnicity (AOR = 3.51; 95 % CI = 1.22-10.11), pre-pandemic overdose (AOR = 6.75; 95 % CI = 3.03-15.02), lack/loss of medical insurance (AOR = 3.02; 95 % CI = 1.01-9.02), relapse (AOR = 2.94; 95 % CI = 1.36-6.36), and nonprescribed use of buprenorphine/naloxone (AOR = 3.16; 95 % CI = 1.49-6.70). The study found similar trends in the treatment sample, with the exceptions that heroin/fentanyl use also predicted overdose (AOR = 3.43; 95 % CI = 1.20-9.78) and the association of overdose with nonprescribed buprenorphine/naloxone was stronger (AOR = 4.91; 95 % CI = 2.01-12.03). Potential mitigating factors, such as take-home methadone and telehealth, were not significant. CONCLUSIONS: Relapse during the pandemic was widespread and a significant contributor to overdose. Lack/loss of medical insurance further exacerbated the risk. Despite the growing literature reporting "therapeutic" use of NPB, people using nonprescribed buprenorphine/naloxone in the current study experienced up to five times the risk of overdose as nonusers. This finding suggests that, despite therapeutic intent, PWUO may be using NPB in ways that are ineffectual for addiction management, especially in the context of changing buprenorphine induction protocols in the context of fentanyl.

Evaluation and guide for embedding opioid use disorder education in health professions' curricula.

BACKGROUND: Morbidity and mortality from Opioid Use Disorder is a health crisis in the United States. During the COVID-19 pandemic, there was a devastating increase of 38.4% in overdose deaths from the 12-month period leading up to June 2019 compared with the 12-month period leading up to May 2020, primarily driven by synthetic opioids. Buprenorphine is an effective medication for opioid use disorder but uptake is slow due in part to lack of provider knowledge, confidence, and negative attitudes/stigma toward patients with OUD. Addressing these barriers in academic training is a promising approach to building workforce able to effectively treat opioid use disorder. METHODS: Our university developed a training for pre-licensure physicians, physician assistants and psychiatric nurse practitioners that included the DATA Waiver training and a shadowing experience. Expected outcomes included improved knowledge, skills and attitudes about persons with OUD and buprenorphine treatment, plans to provide this treatment post-graduation, for pre-licensure learners to have completed all requirements to prescribe buprenorphine post-graduation, and for the training to be embedded into school's curricula. RESULTS: Results were positive overall including improved knowledge and attitudes toward persons with OUD, better understanding of the benefits of this treatment for patients, increased confidence and motivation to provide this treatment post-graduation. The training is now embedded in each program's graduation requirements. CONCLUSION: Developing a didactic and experiential training on buprenorphine treatment for opioid use disorder and embedding it into medical, physician assistant, and psychiatric nurse practitioner licensure programs can help prepare future providers to treat opioid use disorder in a range of settings. Key to replicating this program in other university settings is to engage faculty members who actively provide treatment to persons with OUD to ensure shadowing opportunities and serve as role models for learners.