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.).

Effect of the Communities That HEAL Intervention on Overdose Education and Naloxone Distribution: A Cluster-Randomized, Wait-List Controlled Trial.

Objectives. To determine whether the Communities That HEAL (CTH) intervention is effective in increasing naloxone distribution compared with usual care. Methods. The HEALing (Helping to End Addiction Long-Term) Communities Study (HCS) is a cluster-randomized, parallel-arm, wait-list controlled implementation science trial testing the impact of the CTH intervention on increasing the use of evidence-based practices to lower opioid-related overdose deaths. Communities (n = 67) highly impacted by opioid overdose in Kentucky, Massachusetts, New York, and Ohio were allocated to CTH intervention (n = 34) or wait-list comparison (usual care; n = 33) arms. The primary outcome for this study was the number of naloxone units distributed in HCS communities during the comparison period (July 1, 2021‒June 30, 2022), examined using an intent-to-treat negative binomial regression model. Results. Naloxone distribution was 79% higher in the CTH intervention versus usual care arm (adjusted relative rate = 1.79; 95% confidence interval = 1.28, 2.51; P = .001; adjusted rates of naloxone distribution 3378 vs 1884 naloxone units per 100 000 residents), when controlling for urban‒rural status, state, baseline opioid-related overdose death rate, and baseline naloxone distribution rate. Conclusions. The CTH intervention increased naloxone distribution compared with usual care in communities highly impacted by the opioid crisis. Trial Registration. ClinicalTrials.gov identifier: NCT04111939. (Am J Public Health. Published online ahead of print October 10, 2024:e1-e12. https://doi.org/10.2105/AJPH.2024.307845).

Data Collection and Harmonization in HIV Research: The Seek, Test, Treat, and Retain Initiative at the National Institute on Drug Abuse.

Large-scale, multisite data sets offer the potential for exploring the public health benefits of biomedical interventions. Data harmonization is an emerging strategy to increase the comparability of research data collected across independent studies, enabling research questions to be addressed beyond the capacity of any individual study. The National Institute on Drug Abuse recently implemented this novel strategy to prospectively collect and harmonize data across 22 independent research studies developing and empirically testing interventions to effectively deliver an HIV continuum of care to diverse drug-abusing populations. We describe this data collection and harmonization effort, collectively known as the Seek, Test, Treat, and Retain Data Collection and Harmonization Initiative, which can serve as a model applicable to other research endeavors.

Solving the "last mile" problem in overdose prevention: Lessons from the HEALing Communities Study.

The concept of the "last mile," crucial in logistics for its complexity and cost, has a parallel in public health services. The last mile in public health is fraught with issues such as fragmented services, regulatory barriers, and resistance to evidence-based interventions. This commentary draws parallels between the challenges in delivering goods to consumers' doorsteps and the difficulties in delivering interventions to reduce overdoses in the community. The HEALing Communities Study (HCS), a large implementation science research study, provides an example of how to navigate some of these last-mile challenges. HCS used a community-driven process that considered local characteristics and preferences, and engaged people with lived experience to create effective and sustainable solutions. However, the study also encountered significant challenges in building a delivery infrastructure, working with delayed and incomplete data, and overcoming stigma around substance use interventions. Lessons from the logistics sector can help improve the efficiency and equity of overdose prevention efforts, ensuring that people receive the life-saving interventions they need.

Telemedicine Buprenorphine Initiation and Retention in Opioid Use Disorder Treatment for Medicaid Enrollees.

Importance: Early COVID-19 mitigation strategies placed an additional burden on individuals seeking care for opioid use disorder (OUD). Telemedicine provided a way to initiate and maintain transmucosal buprenorphine treatment of OUD. Objective: To examine associations between transmucosal buprenorphine OUD treatment modality (telemedicine vs traditional) during the COVID-19 public health emergency and the health outcomes of treatment retention and opioid-related nonfatal overdose. Design, Setting, and Participants: This retrospective cohort study was conducted using Medicaid claims and enrollment data from November 1, 2019, to December 31, 2020, for individuals aged 18 to 64 years from Kentucky and Ohio. Data were collected and analyzed in June 2022, with data updated during revision in August 2023. Exposures: The primary exposure of interest was the modality of the transmucosal buprenorphine OUD treatment initiation. Relevant patient demographic and comorbidity characteristics were included in regression models. Main Outcomes and Measures: There were 2 main outcomes of interest: retention in treatment after initiation and opioid-related nonfatal overdose after initiation. For outcomes measured after initiation, a 90-day follow-up period was used. The main analysis used a new-user study design; transmucosal buprenorphine OUD treatment initiation was defined as initiation after more than a 60-day gap in buprenorphine treatment. In addition, uptake of telemedicine for buprenorphine was examined, overall and within patients initiating treatment, across quarters in 2020. Results: This study included 41 266 individuals in Kentucky (21 269 women [51.5%]; mean [SD] age, 37.9 [9.0] years) and 50 648 individuals in Ohio (26 425 women [52.2%]; mean [SD] age, 37.1 [9.3] years) who received buprenorphine in 2020, with 18 250 and 24 741 people initiating buprenorphine in Kentucky and Ohio, respectively. Telemedicine buprenorphine initiations increased sharply at the beginning of 2020. Compared with nontelemedicine initiation, telemedicine initiation was associated with better odds of 90-day retention with buprenorphine in both states (Kentucky: adjusted odds ratio, 1.13 [95% CI, 1.01-1.27]; Ohio: adjusted odds ratio, 1.19 [95% CI, 1.06-1.32]) in a regression analysis adjusting for patient demographic and comorbidity characteristics. Telemedicine initiation was not associated with opioid-related nonfatal overdose (Kentucky: adjusted odds ratio, 0.89 [95% CI, 0.56-1.40]; Ohio: adjusted odds ratio, 1.08 [95% CI, 0.83-1.41]). Conclusions and Relevance: In this cohort study of Medicaid enrollees receiving buprenorphine for OUD, telemedicine buprenorphine initiation was associated with retention in treatment early during the COVID-19 pandemic. These findings add to the literature demonstrating positive outcomes associated with the use of telemedicine for treatment of OUD.

Addressing opioid overdose deaths: The vision for the HEALing communities study.

The United States is facing two devastating public health crises- the opioid epidemic and the COVID-19 pandemic. Within this context, one of the most ambitious implementation studies in addiction research is moving forward. Launched in May 2019, the HEALing Communities Study (HCS) was developed by the National Institutes of Health (NIH) and the Substance Abuse and Mental Health Services Administration (SAMHSA) as part of the Helping to End Addiction Long-termSM Initiative (National Institutes of Health, 2020). The goal for this research was to reduce opioid overdose deaths by 40 % in three years by enhancing and integrating the delivery of multiple evidence-based practices (EBPs) with proven effectiveness in reducing opioid overdose deaths across health care, justice, and community settings. This paper describes the initial vision, goals, and objectives of this initiative; the impact of COVID-19; and the potential for knowledge to be generated from HCS at the intersection of an unrelenting epidemic of opioid misuse and overdoses and the ravishing COVID-19 pandemic.

Health communication campaigns to drive demand for evidence-based practices and reduce stigma in the HEALing communities study.

BACKGROUND: The HEALing Communities Study (HCS) is testing whether the Communities that Heal (CTH) intervention can decrease opioid overdose deaths through the implementation of evidence-based practices (EBPs) in highly impacted communities. One of the CTH intervention components is a series of communications campaigns to promote the implementation of EBPs, increase demand for naloxone and medications for opioid use disorder (MOUD), and decrease stigma toward people with opioid use disorder and the use of EBPs, especially MOUD. This paper describes the approach to developing and executing these campaigns. METHODS: The HCS communication campaigns are developed and implemented through a collaboration between communication experts, research site staff, and community coalitions using a three-stage process. The Prepare phase identifies priority groups to receive campaign messages, develops content for those messages, and identifies a "call to action" that asks people to engage in a specific behavior. In the Plan phase, campaign resources are produced, and community coalitions develop plans to distribute campaign materials. During the Implement stage, these distribution plans guide delivery of content to priority groups. Fidelity measures assess how community coalitions follow their distribution plan as well as barriers and facilitators to implementation. An evaluation of the communication campaigns is planned. CONCLUSIONS: If successful, the Prepare-Plan-Implement process, and the campaign materials, could be adapted and used by other communities to address the opioid crisis. The campaign evaluation will extend the evidence base for how communication campaigns can be developed and implemented through a community-engaged process to effectively address public health crises.

The Opioid-overdose Reduction Continuum of Care Approach (ORCCA): Evidence-based practices in the HEALing Communities Study.

BACKGROUND: The number of opioid-involved overdose deaths in the United States remains a national crisis. The HEALing Communities Study (HCS) will test whether Communities That HEAL (CTH), a community-engaged intervention, can decrease opioid-involved deaths in intervention communities (n = 33), relative to wait-list communities (n = 34), from four states. The CTH intervention seeks to facilitate widespread implementation of three evidence-based practices (EBPs) with the potential to reduce opioid-involved overdose fatalities: overdose education and naloxone distribution (OEND), effective delivery of medication for opioid use disorder (MOUD), and safer opioid analgesic prescribing. A key challenge was delineating an EBP implementation approach useful for all HCS communities. METHODS: A workgroup composed of EBP experts from HCS research sites used literature reviews and expert consensus to: 1) compile strategies and associated resources for implementing EBPs primarily targeting individuals 18 and older; and 2) determine allowable community flexibility in EBP implementation. The workgroup developed the Opioid-overdose Reduction Continuum of Care Approach (ORCCA) to organize EBP strategies and resources to facilitate EBP implementation. CONCLUSIONS: The ORCCA includes required and recommended EBP strategies, priority populations, and community settings. Each EBP has a "menu" of strategies from which communities can select and implement with a minimum of five strategies required: one for OEND, three for MOUD, and one for prescription opioid safety. Identification and engagement of high-risk populations in OEND and MOUD is an ORCCArequirement. To ensure CTH has community-wide impact, implementation of at least one EBP strategy is required in healthcare, behavioral health, and criminal justice settings, with communities identifying particular organizations to engage in HCS-facilitated EBP implementation.

Hazardous alcohol use, antiretroviral therapy receipt, and viral suppression in people living with HIV who inject drugs in the United States, India, Russia, and Vietnam.

OBJECTIVES: In high-income countries, hazardous alcohol use is associated with reduced receipt of antiretroviral therapy (ART) and viral suppression among people living with HIV (PLHIV) who inject drugs. These associations are less understood in lower middle-income countries (LMIC) and upper middle-income countries. DESIGN: We examined associations between hazardous alcohol use, ART receipt, and viral suppression among PLHIV who reported current or former injection drug use. Participants were from nine studies in the United States (high-income country), India (LMIC), Russia (upper middle-income country), and Vietnam (LMIC). METHODS: Hazardous alcohol use was measured via Alcohol Use Disorders Identification Test. Outcomes were HIV viral suppression (viral load of <1000 RNA copies/ml) and self-reported ART receipt. Logistic regression assessed associations between hazardous alcohol use and both outcome variables, controlling for age and sex, among participants with current and former injection drug use. RESULTS: Among 2790 participants, 16% were women, mean age was 37.1 ±â€Š9.5 years. Mean Alcohol Use Disorders Identification Test scores were 4.6 ±â€Š8.1 (women) and 6.2 ±â€Š8.3 (men); 42% reported ART receipt; 40% had viral suppression. Hazardous alcohol use was significantly associated with reduced ART receipt in India (adjusted odds ratio = 0.59, 95% confidence interval: 0.45-0.77, P < 0.001); and lower rates of viral suppression in Vietnam (adjusted odds ratio = 0.51, 95% confidence interval: 0.31-0.82, P = 0.006). CONCLUSION: Associations between hazardous alcohol use, ART receipt, and viral suppression varied across settings and were strongest in LMICs. Addressing hazardous alcohol use holds promise for improving HIV continuum of care outcomes among PLHIV who inject drugs. Specific impact and intervention needs may differ by setting.

Treating drug abuse and addiction in the criminal justice system: improving public health and safety.

Despite increasing evidence that addiction is a treatable disease of the brain, most individuals do not receive treatment. Involvement in the criminal justice system often results from illegal drug-seeking behavior and participation in illegal activities that reflect, in part, disrupted behavior ensuing from brain changes triggered by repeated drug use. Treating drug-involved offenders provides a unique opportunity to decrease substance abuse and reduce associated criminal behavior. Emerging neuroscience has the potential to transform traditional sanction-oriented public safety approaches by providing new therapeutic strategies against addiction that could be used in the criminal justice system. We summarize relevant neuroscientific findings and evidence-based principles of addiction treatment that, if implemented in the criminal justice system, could help improve public heath and reduce criminal behavior.

Addressing the intersecting problems of opioid misuse and chronic pain treatment.

Misuse of prescription opioid medications has continued as a major public health problem in the United States. Review of major epidemiologic databases shows that the prevalence of opioid misuse rose markedly through the 1990s and the early part of the current decade. In this same period of time, the number of prescriptions for chronic noncancer pain increased markedly, and the intersection of these two public health problems remains a concern. Further, despite some leveling off of the overall rate of prescription opioid misuse in the past several years, surveillance data show high and increasing mortality associated with these drugs. Analysis of the 2006 National Survey of Drug Use and Health indicates the increasing prevalence of prescription opioid misuse is associated more with an increase in the general availability of these medications than misuse of the medications by those who were directly prescribed them. National Institute on Drug Abuse initiatives to address the prescription opioid problem include programs to stimulate research in the basic and clinical sciences, and to educate physicians and other health personnel.

Criminal justice measures for economic data harmonization in substance use disorder research.

BACKGROUND: The consequences of substance use disorders (SUDs) are varied and broad, affecting many sectors of society and the economy. Economic evaluation translates these consequences into dollars to examine the net economic impact of interventions for SUD, and associated conditions such as HCV and HIV. The nexus between substance use and crime makes criminal justice outcomes particularly significant for estimating the economic impact of SUD interventions, and important for data harmonization. METHODS: We compared baseline data collected in six NIDA-funded Seek, Test, Treat and Retain (STTR) intervention studies that enrolled HIV-infected/at-risk individuals with SUDs (total n = 3415). Criminal justice measures included contacts with the criminal justice system (e.g., arrests) and criminal offenses. The objective was to develop a list of recommended measures and methods supporting economic data harmonization opportunities in HIV and SUD research, with an initial focus on crime-related outcomes. RESULTS: Criminal justice contacts and criminal offenses were highly variable across studies. When measures grouped by offense classifications were compared, consistencies across studies emerged. Most individuals report being arrested for property or public order crimes (> 50%); the most commonly reported offenses were prostitution/pimping, larceny/shoplifting, robbery, and household burglary. CONCLUSIONS: We identified four measures that are feasible and appropriate for estimating the economic consequences of SUDs/HIV/HCV: number of arrests, number of convictions, days of incarceration, and times committing criminal offenses, by type of offense. To account for extreme variation, grouping crimes by offense classification or calculating monthly averages per event allows for more meaningful comparisons across studies.

Implementing Effective Substance Abuse Treatments in General Medical Settings: Mapping the Research Terrain.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA), and Veterans Health Administration (VHA) share an interest in promoting high quality, rigorous health services research to improve the availability and utilization of evidence-based treatment for substance use disorders (SUD). Recent and continuing changes in the healthcare policy and funding environments prioritize the integration of evidence-based substance abuse treatments into primary care and general medical settings. This area is a prime candidate for implementation research. Recent and ongoing implementation projects funded by these agencies are reviewed. Research in five areas is highlighted: screening and brief intervention for risky drinking; screening and brief intervention for tobacco use; uptake of FDA-approved addiction pharmacotherapies; safe opioid prescribing; and disease management. Gaps in the portfolios, and priorities for future research, are described.

Risk and resistance perspectives in translation-oriented etiology research.

Risk for a disorder and the mechanisms that determine its elevation, risk factors, are the focus of medical research. Targeting risk factors should serve the goal of prevention and treatment intervention. Risk, however, is but one of the aspects of liability to a disorder, a latent trait that encompasses effects of all factors leading to or from the diagnostic threshold. The coequal but opposite aspect of liability is resistance to a disorder. The factors that increase resistance and thus enable prevention or recovery may differ from those that elevate risk. Accordingly, there are nontrivial differences between research perspectives that focus on risk and on resistance. This article shows how this distinction translates into goals and methods of research and practice, from the choice of potential mechanisms tested to the results sought in intervention. The resistance concept also differs from those of "resilience" and "protective factors," subsuming but not limited to them. The implications of the concept are discussed using substance use disorder as an example and substantiate the need for biomedical research and its translation to shift to the resistance perspective.

The SOMATICS collaborative: Introduction to a National Institute on Drug Abuse cooperative study of pharmacotherapy for opioid treatment in criminal justice settings.

BACKGROUND: Among the nearly 750,000 inmates in U.S. jails, 12% report using opioids regularly, 8% report use in the month prior to their offense, and 4% report use at the time of their offense. Although ample evidence exists that medications effectively treat Opiate Use Disorder (OUD) in the community, strong evidence is lacking in jail settings. The general lack of medications for OUD in jail settings may place persons suffering from OUD at high risk for relapse to drug use and overdose following release from jail. METHODS: The three study sites in this collaborative are pooling data for secondary analyses from three open-label randomized effectiveness trials comparing: (1) the initiation of extended-release naltrexone [XR-NTX] in Sites 1 and 2 and interim methadone in Site 3 with enhanced treatment-as usual (ETAU); (2) the additional benefit of patient navigation plus medications at Sites 2 and 3 vs. medication alone vs. ETAU. Participants are adults with OUD incarcerated in jail and transitioning to the community. RESULTS: We describe the rationale, specific aims, and designs of three separate studies harmonized to enhance their scientific yield to investigate how to best prevent jail inmates from relapsing to opioid use and associated problems as they transition back to the community. CONCLUSIONS: Conducting drug abuse research during incarceration is challenging and study designs with data harmonization across different sites can increase the potential value of research to develop effective treatments for individuals in jail with OUD.

Implementing drug abuse treatment services in criminal justice settings: Introduction to the CJ-DATS study protocol series.

BACKGROUND: Despite a growing pipeline of effective clinical treatments, there remains a persistent research-to-practice gap in drug abuse services. Delivery of effective treatment services is especially lacking in the U.S. criminal justice system, where half of all incarcerated persons meet the need for drug abuse or dependence, yet few receive needed care. Structural, financial, philosophical and other barriers slow the pace of adoption of available evidence-based practices. These challenges led to the development of a multi-site cooperative research endeavor known as the Criminal Justice Drug Abuse Treatment Studies (CJ-DATS), funded by the National Institute on Drug Abuse (NIDA). CJ-DATS engages university-based research teams, criminal justice agencies, and community-based treatment providers in implementation research studies to test strategies for enhancing treatment service delivery to offender populations. METHODS: This Introduction reviews the mission of NIDA, the structure and goals of the CJ-DATS cooperative, and the implementation studies being conducted by the participating organizations. The component Study Protocols in this article collection are then described. DISCUSSION: CJ-DATS applies implementation science perspectives and methods to address a vexing problem - the need to link offender populations with effective treatment for drug abuse, HIV, and other related conditions for which they are at high risk. Applying these principles to the U.S. criminal justice system is an innovative extension of lessons that have been learned in mainstream healthcare settings. This collection is offered as both an introduction to NIDA's work in this area, as well as a window onto the challenges of conducting health services research in settings in which improving public health is not the organization's core mission.

Understanding the importance of organizational and system variables on addiction treatment services within criminal justice settings.

NIDA's Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) is the primary vehicle for testing emerging treatment interventions and fostering adoption of evidence-based therapies in criminal justice settings. The papers in this issue of Drug and Alcohol Dependence use data from the CJ-DATS National Criminal Justice Treatment Practice Survey to explore the influence of organizational and system variables on access to addiction treatment and the types of services available within correctional settings. This essay provides context for the papers in this issue of Drug and Alcohol Dependence. Systems and organizational interventions that improve the delivery and quality of drug abuse treatment services are described and the potential to apply systems change thinking to addiction treatment services available in the criminal justice system is discussed. Each paper is described briefly. CJ-DATS is evolving to support research at the organizational and systems level that facilitates the implementation and sustainability of research-supported treatments and business practices in criminal justice settings.