Community-Based Cluster-Randomized Trial to Reduce Opioid Overdose Deaths.

BACKGROUND: Evidence-based practices for reducing opioid-related overdose deaths include overdose education and naloxone distribution, the use of medications for the treatment of opioid use disorder, and prescription opioid safety. Data are needed on the effectiveness of a community-engaged intervention to reduce opioid-related overdose deaths through enhanced uptake of these practices. METHODS: In this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population. The primary outcome was the number of opioid-related overdose deaths among community adults. RESULTS: During the comparison period from July 2021 through June 2022, the population-averaged rates of opioid-related overdose deaths were similar in the intervention group and the control group (47.2 deaths per 100,000 population vs. 51.7 per 100,000 population), for an adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; P = 0.30). The effect of the intervention on the rate of opioid-related overdose deaths did not differ appreciably according to state, urban or rural category, age, sex, or race or ethnic group. Intervention communities implemented 615 evidence-based practice strategies from the 806 strategies selected by communities (254 involving overdose education and naloxone distribution, 256 involving the use of medications for opioid use disorder, and 105 involving prescription opioid safety). Of these evidence-based practice strategies, only 235 (38%) had been initiated by the start of the comparison year. CONCLUSIONS: In this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths, death rates were similar in the intervention group and the control group in the context of the Covid-19 pandemic and the fentanyl-related overdose epidemic. (Funded by the National Institutes of Health; HCS ClinicalTrials.gov number, NCT04111939.).

Management of Infective Endocarditis in People Who Inject Drugs: A Scientific Statement From the American Heart Association.

BACKGROUND: The American Heart Association has sponsored both guidelines and scientific statements that address the diagnosis, management, and prevention of infective endocarditis. As a result of the unprecedented and increasing incidence of infective endocarditis cases among people who inject drugs, the American Heart Association sponsored this original scientific statement. It provides a more in-depth focus on the management of infective endocarditis among this unique population than what has been provided in prior American Heart Association infective endocarditis-related documents. METHODS: A writing group was named and consisted of recognized experts in the fields of infectious diseases, cardiology, addiction medicine, and cardiovascular surgery in October 2021. A literature search was conducted in Embase on November 19, 2021, and multiple terms were used, with 1345 English-language articles identified after removal of duplicates. CONCLUSIONS: Management of infective endocarditis in people who inject drugs is complex and requires a unique approach in all aspects of care. Clinicians must appreciate that it requires involvement of a variety of specialists and that consultation by addiction-trained clinicians is as important as that of more traditional members of the endocarditis team to improve infective endocarditis outcomes. Preventive measures are critical in people who inject drugs and are cured of an initial bout of infective endocarditis because they remain at extremely high risk for subsequent bouts of infective endocarditis, regardless of whether injection drug use is continued.

Long-acting buprenorphine injectables: Opportunity to improve opioid use disorder treatment among rural populations.

The opioid epidemic continues with escalating overdose deaths further exacerbated by the coronavirus pandemic, despite having efficacious medication treatments for opioid use disorder (MOUD). Most persons with OUD remain undiagnosed, without ever receiving MOUD, and even among those who initiate MOUD, retention is infrequently longer than 6 months (Williams et al., 2019). Treatment access remains particularly problematic in rural areas that often have few providers and limited resources (Ghertner, 2019). There are two new injectable long-acting buprenorphine (LAB) formulations recently approved in the United States and abroad (Lofwall et al., 2018; Walsh et al., 2017; Haight et al., 2019). They hold promise to improve treatment access and retention by decreasing risks of nonadherence, diversion and misuse and may be particularly attractive during a pandemic in order to minimize provider and pharmacy contacts (Roberts et al., 2020) and help improve access to care in rural areas. There are several ongoing evaluations of LAB injectables in large multi-site randomized clinical trials sponsored by the National Institute on Drug Abuse and Veterans Administration Office of Research and Development in settings with special populations that exist in both urban and rural settings. Understanding the potential clinical benefits of LAB injectables along the care continuum, particularly for rural areas is essential to successful implementation in the complex healthcare system.

Outpatient Parenteral Antimicrobial Therapy Plus Buprenorphine for Opioid Use Disorder and Severe Injection-related Infections.

In a pilot randomized trial in persons with opioid use disorder hospitalized with injection-related infections, an innovative care model combining outpatient parenteral antimicrobial therapy with buprenorphine treatment had similar clinical and drug use outcomes to usual care (inpatient intravenous antibiotic completion) and shortened hospital length of stay by 23.5 days. CLINICAL TRIALS REGISTRATION: NCT03048643.

Medications for Treatment of Opioid Use Disorder among Persons Living with HIV.

PURPOSE OF REVIEW: Recent HIV outbreaks have occurred as a result of the current US opioid epidemic. Providing medications for opioid use disorder (MOUD) with methadone, buprenorphine, and extended-release naltrexone is essential to achieving optimal HIV treatment outcomes including viral suppression and retention in treatment. This review describes the pharmacology of MOUD with specific attention to interactions with antiretroviral therapy, and to the effect of MOUD on HIV treatment outcomes. RECENT FINDINGS: Methadone and buprenorphine both improve HIV viral suppression, adherence to antiretroviral therapy, and overall mortality for persons with opioid use disorder (OUD). Extended-release naltrexone has been most extensively studied in persons with HIV leaving incarcerated settings, and improves HIV viral suppression in that context. Strategies that integrate MOUD and HIV treatment are crucial to optimize viral suppression. The differing pharmacokinetic and delivery characteristics of these MOUD offer diverse options. Given the chronic and relapsing nature of both HIV and OUD, long-term approaches are required.

Integrated outpatient treatment of opioid use disorder and injection-related infections: A description of a new care model.

Persons with opioid use disorder (OUD) hospitalized with severe, injection-related infections (SIRI) are frequently hospitalized for the duration of IV antibiotic treatment due to concerns regarding their eligibility for outpatient parenteral antimicrobial therapy (OPAT), which is the standard of care for prolonged IV antibiotic courses for patients without drug use. As part of a pilot study, a novel, integrated care model was developed where patients with OUD and SIRI receive addiction consultation and buprenorphine induction while hospitalized, followed by ongoing management in an outpatient clinic that combines office-based opioid treatment with buprenorphine pharmacotherapy and counseling services with OPAT. Through three illustrative case vignettes the outpatient model is described along with challenges, lessons learned and future directions.

Treating Opioid Use Disorder in Patients Who Are Incarcerated: Quandaries of a Hospitalist.

This Viewpoint discusses the importance of ensuring that life-saving medication for opioid use disorder is available to hospitalized persons who are incarcerated.

Extended-release Buprenorphine Administered at Discharge in Hospitalized Persons With Opioid Use Disorder: A Case Series.

INTRODUCTION: Monthly subcutaneous injectable buprenorphine (XR-Bup) is an option for treatment of opioid use disorder (OUD) that addresses some sublingual buprenorphine adherence barriers and is infrequently offered to hospitalized patients with OUD. METHODS: A retrospective case series was performed for patients receiving XR-Bup upon discharge from 1 academic medical center. Demographic information, diagnoses, follow-up, and documented factors informing the selection of XR-Bup were extracted from the electronic health record. RESULTS: In 1 year, 37 hospitalized patients with OUD received XR-Bup at discharge. The average age was 37.6 years, and patients were primarily Medicaid insured with an injection-related infection. The most common documented factors informing the selection of XR-Bup were as follows: previous sublingual buprenorphine adherence barriers, concurrent stimulant use disorder, and patient preference. Sixty-four percent of patients scheduled for follow-up attended appointments, and 55% received a second dose of XR-Bup. CONCLUSIONS: Subcutaneous injectable buprenorphine is an option for OUD treatment among hospitalized patients providing 30 or more days of buprenorphine coverage in the postdischarge period.

Pain Management in Patients With Opioid Use Disorder on Extended-release Buprenorphine: A Case Report.

ABSTRACT: Persons with opioid use disorder (OUD) are receiving extended-release buprenorphine (ER-buprenorphine) for treatment of OUD. There are no clinical guidelines for management of patients with OUD on ER-buprenorphine experiencing acute or chronic pain. This case report describes 3 patient-involved, multidisciplinary approaches for pain management in various clinical scenarios, including a scheduled knee replacement, emergent surgery for an ischemic limb, and management of chronic pain from metastatic malignancy. These cases illustrate that adequate analgesia for patients who have received ER-buprenorphine is possible, and approaches can be individualized, with shared decision making between providers and patients addressing all barriers to optimize treatment outcomes. Options for acute pain management that can be considered include supplemental sublingual buprenorphine, nonopioid adjuncts, and short courses of full opioid agonists. Potential barriers that impact OUD and acute/chronic pain are provider bias, limited access to palliative care clinicians with addiction medicine training, and payor restrictions to adding sublingual buprenorphine for patients that are on ER-buprenorphine. Additional training for clinicians and other members of the health care team is recommended to improve patient-involved care of persons with OUD experiencing pain.

Medications for opioid use disorder associated with reduced readmissions for patients with severe injection-related infections: A matched cohort study.

INTRODUCTION: Hospitalizations due to severe injection-related infections (SIRIs) and patient-directed discharge (PDD) in people who inject drugs (PWID) are increasing, but research on readmission outcomes at PDD is limited. In this retrospective, matched cohort study we evaluated predictors of 30-day readmission by discharge status among PWID. METHODS: Among patients diagnosed with SIRIs at a tertiary hospital, Fisher's exact tests assessed differences in readmission rates by discharge status. Medications for opioid use disorder (MOUD) at discharge was defined as either having a buprenorphine dose dispensed within 24 h of discharge and buprenorphine being included in the discharge summary as a prescription, or a methadone dose dispensed inpatient within 24 h of discharge. Logistic regression analyses evaluated predictors of readmission outcomes. RESULTS: Among 148 PWID with SIRI diagnosis, 30-day readmission rate following PDD was higher than standard discharge (25.7 % vs. 9.5 %, p = 0.016) and MOUD decreased odds of 30-day readmission (OR = 0.32, 95 % CI: 0.12,0.83, p = 0.012). >7 missed days of antibiotic treatment increased odds of 30-day readmission (OR 4.65, 95 % CI: 1.14, 31.72, p = 0.030) within PDD patients. CONCLUSIONS: PDD carries higher 30-day readmission rate compared to standard discharge. Strategies to reduce PDD rates and increase MOUD initiation may improve readmission outcomes.

Get It in Writing: How to Make Medications for Opioid Use Disorder Available During Incarceration.

In a case example from the Kentucky HEALing Communities Study, extensive resources were deployed to address structural barriers and facilitate the provision of medication for opioid use disorder (OUD) in an urban county jail. However, implementation was unsuccessful, and this case example emphasizes the importance of including evidence-based medication for OUD (MOUD) treatment in the scope of work of jails' contracted medical providers. The privatization of correctional health care services allows local governments with opioid abatement funds to incorporate requirements into medical provider contracts to screen all people entering jails for OUD and to offer MOUD at intake, throughout incarceration, and upon release to everyone for whom it is clinically indicated. We provide sample contractual language that can be added to requests for medical provider proposals to help drive the private correctional health care market toward integrating MOUD treatment into their standard of care. This approach also could expedite efforts to scale up broad MOUD access across U.S. jails through sharing of workflows and best practices among the small group of national correctional health care companies contracted with jails in states with broad mandates, such as Massachusetts. Clinical Trial Registration: NCT04111939.

Syringe reuse among people who inject drugs in rural Appalachian Kentucky.

BACKGROUND: Personal syringe reuse (i.e., reuse of one's own syringes) can place people who inject drugs at increased risk for infectious disease but has received relatively little attention in published literature. The purpose of this study is to identify factors associated with syringe reuse among people who inject drugs in rural Kentucky. METHODS: Participants (n = 238) completed interviewer-administered questionnaires on syringe reuse and demographic, behavioral, and service access characteristics. Unadjusted negative binomial regression with cluster-robust standard errors was used to model the associations with a logged offset for number of injections in the past 30 days. RESULTS: The average age of the sample was 35 and 59.7 % were male. Most participants (77.7 %) reused syringes at least once in the past 30 days, using each syringe a median of three times. Reuse was higher among those who were older and reported a higher street price for syringes. Syringe reuse was lower among people who were within walking distance to a syringe service program (SSP) and who obtained most of their syringes from SSPs or pharmacies. CONCLUSION: Syringe reuse among people who inject drugs in rural Kentucky is common. However, these data suggest that increased access to syringes from SSPs and pharmacies, as well as policy-level interventions that reduce street syringe price, might reduce syringe reuse and related harms.

Utilization of long-acting injectable monthly depot buprenorphine for opioid use disorder (OUD) in Kentucky, before and after COVID-19 related buprenorphine access policy changes.

INTRODUCTION: Long-acting injectable buprenorphine (LAI-bup) formulations have advantages over transmucosal buprenorphine (TM-bup), but barriers may limit their utilization. Several policies shifted during the COVID-19 pandemic to promote buprenorphine access. The federal government expanded telemedicine treatment for opioid use disorder and Kentucky (KY) Medicaid lifted prior authorization requirements (PAs) for LAI-bup (i.e., Sublocade®). This retrospective cohort study evaluated changes in LAI-bup access, utilization, and retention before and after these policy changes in KY. METHODS: Individual-level TM-bup and LAI-bup dispensing record data from KY's prescription drug monitoring program examined LAI-bup utilization and retention, without a >30-day gap in coverage, for patients starting a new episode of LAI-bup treatment. Two key time periods were examined: pre-policy changes (Apr 1, 2019 - Dec 31, 2019) and post-policy changes (Apr 1, 2020 - Dec 31, 2020). Data on PA requests among Medicaid managed care organizations and availability of LAI-bup Risk Evaluation and Mitigation Strategy (REMS)-certified pharmacies were also obtained. A multivariable Cox proportional hazard regression model analysis compared pre- versus post-policy period treatment discontinuation. RESULTS: The number of patients initiating LAI-bup increased from 211 to 481 over the two periods. By the end of the post-policy period, 24.3 % of eligible patients were retained on LAI-bup, versus 12.5 % in the pre-policy change period. The adjusted hazard ratio, comparing discontinuation during the post- versus pre-policy change periods, was 0.70 (95 % confidence interval: 0.55-0.89). There were also more REMS-certified pharmacies and providers in the post-policy change period. CONCLUSIONS: LAI-bup access, utilization, and retention increased after several policy changes.

The development of a recovery coaching training curriculum to facilitate linkage to and increase retention on medications for opioid use disorder.

Introduction: Medication treatment for opioid use disorder (MOUD) decreases opioid overdose risk and is the standard of care for persons with opioid use disorder (OUD). Recovery coach (RC)-led programs and associated training curriculums to improve outcomes around MOUD are limited. We describe our comprehensive training curriculum including instruction and pedagogy for novel RC-led MOUD linkage and retention programs and report on its feasibility. Methods­pedagogy and training development: The Kentucky HEALing (Helping to End Addiction Long-termSM) Communities Study (HCS) created the Linkage and Retention RC Programs with a local recovery community organization, Voices of Hope-Lexington. RCs worked to reduce participant barriers to entering or continuing MOUD, destigmatize and educate on MOUD and harm reduction (e.g., safe injection practices), increase recovery capital, and provide opioid overdose education with naloxone distribution (OEND). An extensive hybrid (in-person and online, both synchronous and asynchronous), inclusive learning-focused curriculum to support the programs (e.g., motivational interviewing sessions, role plays, MOUD competency assessment, etc.,) was created to ensure RCs developed the necessary skills and could demonstrate competency before deployment in the field. The curriculum, pedagogy, learning environment, and numbers of RCs trained and community venues receiving a trained RC are reported, along with interviews from three RCs about the training program experience. Results: The curriculum provides approximately 150 h of training to RCs. From December 2020 to February 2023, 93 RCs and 16 supervisors completed the training program; two were unable to pass a final competency check. RCs were deployed at 45 agencies in eight Kentucky HCS counties. Most agencies (72%) sustained RC services after the study period ended through other funding sources. RCs interviewed reported that the training helped them better explain and dispel myths around MOUD. Conclusion: Our novel training and MOUD programs met a current unmet need for the RC workforce and for community agencies. We were able to train and deploy RCs successfully in these new programs aimed at saving lives through improving MOUD linkage and retention. This paper addresses a need to enhance the training requirements around MOUD for peer support specialists.

Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV, HCV and overdose risk in rural Appalachia.

INTRODUCTION: Many rural communities bear a disproportionate share of drug-related harms. Innovative harm reduction service models, such as vending machines or kiosks, can expand access to services that reduce drug-related harms. However, few kiosks operate in the USA, and their implementation, impact and cost-effectiveness have not been adequately evaluated in rural settings. This paper describes the Kentucky Outreach Service Kiosk (KyOSK) Study protocol to test the effectiveness, implementation outcomes and cost-effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C and overdose risk in rural Appalachia. METHODS AND ANALYSIS: KyOSK is a community-level, controlled quasi-experimental, non-randomised trial. KyOSK involves two cohorts of people who use drugs, one in an intervention county (n=425) and one in a control county (n=325). People who are 18 years or older, are community-dwelling residents in the target counties and have used drugs to get high in the past 6 months are eligible. The trial compares the effectiveness of a fixed-site, staffed syringe service programme (standard of care) with the standard of care supplemented with a kiosk. The kiosk will contain various harm reduction supplies accessible to participants upon valid code entry, allowing dispensing data to be linked to participant survey data. The kiosk will include a call-back feature that allows participants to select needed services and receive linkage-to-care services from a peer recovery coach. The cohorts complete follow-up surveys every 6 months for 36 months (three preceding kiosk implementation and four post-implementation). The study will test the effectiveness of the kiosk on reducing risk behaviours associated with overdose, HIV and hepatitis C, as well as implementation outcomes and cost-effectiveness. ETHICS AND DISSEMINATION: The University of Kentucky Institutional Review Board approved the protocol. Results will be disseminated in academic conferences and peer-reviewed journals, online and print media, and community meetings. TRIAL REGISTRATION NUMBER: NCT05657106.

Effect of the Communities that HEAL intervention on receipt of behavioral therapies for opioid use disorder: A cluster randomized wait-list controlled trial.

BACKGROUND: The U.S. opioid overdose crisis persists. Outpatient behavioral health services (BHS) are essential components of a comprehensive response to opioid use disorder and overdose fatalities. The Helping to End Addiction Long-Term® (HEALing) Communities Study developed the Communities That HEAL (CTH) intervention to reduce opioid overdose deaths in 67 communities in Kentucky, Ohio, New York, and Massachusetts through the implementation of evidence-based practices (EBPs), including BHS. This paper compares the rate of individuals receiving outpatient BHS in Wave 1 intervention communities (n = 34) to waitlisted Wave 2 communities (n = 33). METHODS: Medicaid data included individuals ≥18 years of age receiving any of five BHS categories: intensive outpatient, outpatient, case management, peer support, and case management or peer support. Negative binomial regression models estimated the rate of receiving each BHS for Wave 1 and Wave 2. Effect modification analyses evaluated changes in the effect of the CTH intervention between Wave 1 and Wave 2 by research site, rurality, age, sex, and race/ethnicity. RESULTS: No significant differences were detected between intervention and waitlisted communities in the rate of individuals receiving any of the five BHS categories. None of the interaction effects used to test the effect modification were significant. CONCLUSIONS: Several factors should be considered when interpreting results-no significant intervention effects were observed through Medicaid claims data, the best available data source but limited in terms of capturing individuals reached by the intervention. Also, the 12-month evaluation window may have been too brief to see improved outcomes considering the time required to stand-up BHS. TRIAL REGISTRATION: Clinical Trials.gov http://www. CLINICALTRIALS: gov: Identifier: NCT04111939.

Effects of the Communities that Heal (CTH) intervention on perceived opioid-related community stigma in the HEALing Communities Study: results of a multi-site, community-level, cluster-randomized trial.

Background: Community stigma against people with opioid use disorder (OUD) and intervention stigma (e.g., toward naloxone) exacerbate the opioid overdose crisis. We examined the effects of the Communities that HEAL (CTH) intervention on perceived opioid-related community stigma by stakeholders in the HEALing Communities Study (HCS). Methods: We collected three surveys from community coalition members in 66 communities across four states participating in HCS. Communities were randomized into Intervention (Wave 1) or Wait-list Control (Wave 2) arms. We conducted multilevel linear mixed models to compare changes in primary outcomes of community stigma toward people treated for OUD, naloxone, and medication for opioid use disorder (MOUD) by arm from time 1 (before the start of the intervention) to time 3 (end of the intervention period in the Intervention arm). Findings: Intervention stakeholders reported a larger decrease in perceived community stigma toward people treated for OUD (adjusted mean change (AMC) -3.20 [95% C.I. -4.43, -1.98]) and toward MOUD (AMC -0.33 [95% C.I. -0.56, -0.09]) than stakeholders in Wait-list Control communities (AMC -0.18 [95% C.I. -1.38, 1.02], p = 0.0007 and AMC 0.11 [95% C.I. -0.09, 0.31], p = 0.0066). The relationship between intervention status and change in stigma toward MOUD was moderated by rural-urban status (urban AMC -0.59 [95% CI, -0.87, -0.32], rural AMC not sig.) and state. The difference in stigma toward naloxone between Intervention and Wait-list Control stakeholders was not statistically significant (p = 0.18). Interpretation: The CTH intervention decreased stakeholder perceptions of community stigma toward people treated for OUD and stigma toward MOUD. Implementing the CTH intervention in other communities could decrease OUD stigma across diverse settings nationally. Funding: US National Institute on Drug Abuse.