Abstract
Many individuals with opioid use disorder come into contact with the justice system each year, making the nexus between the criminal justice system and the healthcare system a critical juncture for responding to the opioid crisis and simultaneously promoting public health and public safety. Collaborations across these sectors are essential to providing effective screening, treatment, and discharge planning; connecting individuals to services following release; promoting long-term recovery while reducing recidivism; and ultimately bringing the opioid crisis under control. In 2019, with the support of the NIH Helping to End Addiction Long-term (HEAL) Initiative, the National Institute on Drug Abuse launched the Justice Community Opioid Innovation Network (JCOIN). JCOIN is a >$150M multisite cooperative designed to facilitate transdisciplinary collaborations that can create actionable, translatable insights for the justice system and community-based organizations to address the opioid epidemic in justice-involved populations. JCOIN brings together 11 Research Hubs, a Coordination and Translation Center (CTC), and a Methodology and Advanced Analytics Resource Center (MAARC), with the goal of generating evidence that is greater than the sum of the parts. Collectively, the network will field at least 12 large-scale multi-site clinical trials, which are described in this special issue. This article provides a brief overview of the scientific underpinnings for these trials; describes the broad themes connecting them; and discusses the intersections of the JCOIN initiative with the COVID-19 pandemic.
Keywords: opioid use disorder, justice system, addiction treatment, clinical trials, implementation science
1. Introduction
Approximately 2 million individuals are incarcerated in the US in any given year, with an estimated 4.7 million under community supervision (probation or parole). Available data indicate that more than half of individuals incarcerated in US prisons and jails met DSM-IV criteria for substance abuse or dependence, with roughly one in 5 individuals reporting regular opioid use (Bronson et al., 2017). Provision of evidence-based treatment for substance use disorder (SUD) and especially opioid use disorder (OUD) within correctional settings is rare, owing to a shortage of resources, regulatory hurdles, persistent stigma and misperceptions about pharmacotherapies, and concerns about medication diversion (Fiscella et al., 2018). Studies suggest that fewer than 1% of individuals meeting diagnostic criteria receive any of the FDA-approved medications for opioid use disorder (MOUD) while incarcerated (Bronson et al., 2017; Fox 2015), despite compelling evidence that provision of these medications is associated with better opioid outcomes post-release, including reductions in relapse, recidivism, and overdose deaths (Green et al., 2018; Marsden et al., 2017; Moore et al., 2018).
Limited service provision within carceral settings has significant and persistent spillover effects. As many as 95% of those who are incarcerated will eventually return to the community (Bureau of Justice Statistics, 2020) where those with untreated OUD face numerous challenges in connecting with community-based treatment, social services, housing, and other essential supports (Joudrey et al., 2019). Community re-entry is a high-risk period when many individuals “fall through the cracks” between systems. These issues are magnified for black, indigenous, and other people of color (BIPOC), as persistent systemic racism is inextricably linked with arrest and incarceration rates, access to effective services, and health and mortality outcomes.
As policymakers, researchers, clinicians, and advocates work to respond to the opioid crisis, it has become clear that interagency collaboration is essential to successfully addressing the treatment needs of this population. Cross-sector collaborations between the criminal justice system and healthcare system are essential for providing effective OUD treatment, connecting individuals to services following release, and promoting long-term recovery while reducing recidivism. In short, collaborative efforts are needed to reconcile divergent agency missions by demonstrating that, in providing effective services to address opioid use and OUD, public health and public safety are complementary and not competing goals.
It is against this backdrop that the National Institute on Drug Abuse (NIDA) in 2019 launched the Justice Community Opioid Innovation Network (JCOIN), a $150M cooperative agreement to facilitate transdisciplinary collaborations that can create actionable, translatable insights for the justice system and community-based organizations to address the opioid epidemic in justice-involved populations. JCOIN is primarily funded through the National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative, an aggressive trans-NIH effort to improve prevention and treatment strategies for opioid misuse and OUD, and to enhance pain management. This special issue of the Journal of Substance Abuse Treatment describes the study protocols for 12 JCOIN clinical trials that have been funded as of September 2020 and will be conducted over the next 5 years.
JCOIN is designed to generate new evidence about effectively treating OUD in justice-involved populations, including strategies to ensure continued access to OUD services as individuals transition between incarceration and the community. Twelve clinical trials and numerous other research activities, conducted via collaborative partnerships between researchers and justice and community agency partners, are the engine for generating this evidence. Ongoing opportunities for bi-directional communication are meant to ensure that the research findings can be rapidly translated, implemented, and sustained in justice agencies and community treatment settings.
2. The Justice Community Opioid Innovation Network
2.1. JCOIN Structure
JCOIN brings together 11 Research Hubs, a Coordination and Translation Center (CTC), and a Methodology and Advanced Analytics Resource Center (MAARC). Each Research Hub includes at least one academic research center partnered with justice and treatment agencies in a minimum of 5 distinct communities. The CTC conducts research on effective dissemination and implementation strategies; engages stakeholders within the network and across the U.S.; supports capacity building activities including programs that provide training, technical assistance, and pilot grant funding; and coordinates activities for the entire network. In addition to providing data infrastructure and analytic support for JCOIN, the MAARC also conducts original research that will complement and extend the network’s clinical trials, including simulation modeling studies, as well as national agency and public opinion surveys. While this special issue focuses on the clinical trial protocols, JCOIN’s robust infrastructure provides the support necessary for translating, disseminating, extending, and amplifying the findings and insights of the trials described herein. Further, it provides critical supports for building the next generation of investigators and collaborators working at the intersection of justice and health.
Extending the example of other recent NIH-funded collaboratives (Blachman-Demner et al., 2017; Leukefeld et al., 2017), JCOIN’s Steering Committee comprises the lead investigator of the Research Hubs, MAARC, and CTC, along with one justice system representative and one healthcare/treatment system representative from each Research Hub, who serve as full partners and voting members. This structure ensures that the practitioners have meaningful input not only in the direction of the network but also in identifying practical issues that are a priority for research. For example, while peer navigation is a common strategy for linking individuals with community-based services at re-entry, many questions remain about the minimum necessary characteristics and credentials to ensure the success of these services (Gagne et al., 2018). Likewise, practical questions around MOUD prescribing – including timing, induction protocols, and transitions between medications – can be addressed by embedding these questions in the research studies.
While the Research Hubs execute their projects locally, the Steering Committee provides a venue for both the researchers and practitioners to identify gaps in the network’s portfolio and develop additional study protocols to address these questions. A number of thematic workgroups incorporate research and practitioner representatives from each study team, gathering input on cross-cutting issues that include common core measures, data and human subjects protections, best practices for MOUD prescribing, and implications for implementation and sustainability. Integrating practitioners as partners in the network reinforces the goal of speeding science-to-services translation and ensures that the funded studies benefit equally from scientific rigor and practitioner expertise (Holt & Chambers, 2017).
2.2. JCOIN Science
Across the network, JCOIN research spans the cascade of care for OUD (Williams et al., 2019), and this conceptual framework allows for the identification of service gaps and improvements over time, even across a disparate set of studies. Employing this common framework also permits the identification of areas where scientific research is still needed to inform and improve care delivery. Collectively, the component studies will generate evidence about identification of individual service needs, linkage to community-based services, treatment engagement (including medication induction and adherence), retention in care, and recovery support, as well as health services utilization and recidivism. Including practitioners and individuals with lived experience in the design, execution, and interpretation of the research should enhance the relevance of the findings for justice and treatment agencies, increase the likely impact on routine practice, and ensure that the needs and preferences of the intended recipients are represented.
The JCOIN trials can be grouped by three broad themes: (1) comparative effectiveness trials of MOUD; (2) natural experiments capitalizing on ongoing state policy rollouts; and (3) trials examining “linkage facilitation” strategies to connect individuals with community-based treatment services at re-entry. Study settings include prisons, jails, community corrections (probation/parole), drug courts, and juvenile justice agencies. (See Figure 1.)
3.0. JCOIN Study Protocols
3.1. MOUD Comparative Effectiveness Trials
All of the JCOIN trials include components that will link participants to treatment providers who can prescribe the full complement of MOUD options (methadone, naltrexone, and buprenorphine). Two studies are staging multisite comparative effectiveness trials focused on the newest formulations of injectable extended-release buprenorphine. The NYU School of Medicine Hub (Waddell et al., this issue) will compare the effectiveness of extended-release buprenorphine (Sublocade®) to extended-release naltrexone, while the Friends Research Institute Hub (Gordon et al., this issue) will test the newer Brixadi® formulation of extended-release buprenorphine vs. extended-release naltrexone. In both trials, individuals will be enrolled, randomized, and receive their initial medication dose prior to release from jail, followed by an additional 6 months of treatment in the community. Independent trials were deemed important because of the unique logistical issues (e.g., storage, induction, dosing schedule, cost) that each formulation would present for real-world scale-up of these medications in correctional settings. These two studies have largely harmonized their measures and methods, to allow for combined and comparative analyses above and beyond the individual trials.
3.2. State Policy Rollouts
Two JCOIN hubs capitalize on ongoing state policy rollouts to learn about implementation processes and outcomes. In Massachusetts, 7 state Houses of Correction (i.e., jails) are participating in a state-mandated pilot in which all three MOUD options are offered to all opioid dependent individuals while incarcerated, and through linkages to community-based treatment on release. The Massachusetts Hub (Evans et al., this issue) will conduct a longitudinal treatment outcome study of individuals in these jails, utilizing the state’s robust public health data system to track treatment, health, and recidivism outcomes over time. The study will also identify strategies associated with the successful implementation of MOUD.
The state of New York is seeking to implement a new opioid court model (OCM), offering practice guidelines for drug courts to reduce overdose, decrease recidivism, and improve service delivery and linkages to MOUD for justice-involved individuals across the state. The JCOIN project (Ryan et al., this issue) will test an implementation strategy to train court staff in the core principles of this model, and utilize administrative data to measure client outcomes over time. The goal of the study is to develop, evaluate, and refine implementation strategies to support the OCM practice guidelines to be scaled up across New York. Together, these two trials will yield important insights on implementation barriers, challenges, and possible solutions to assist policy implementation efforts in other states.
3.3. Linkage Facilitation
Seven JCOIN hubs are testing various models for effectively linking individuals with community-based MOUD and related treatment services upon release from jail or prison, or while under community supervision. The Chestnut Health Systems Hub (Scott et al., this issue) is comparing two approaches to assist justice-involved individuals with referral or assertive linkage to a designated treatment provider upon release from jail. The study compares the effectiveness of the Recovery Management Checkups (RMC) model, an evidence-based intervention that provides regular, fixed schedule check-ups to support treatment retention and recovery, versus an adaptive model (RMC-Adapted) that tailors checkup frequency and intensity to individuals’ needs.
The University of Chicago Hub (Pollack et al., this issue) is conducting a multi-site trial called ROMI (Reducing Opioid Mortality in Illinois) to study the effectiveness of case management approaches to link individuals with community-based treatment services upon release from jail. The ROMI intervention includes peer recovery coaches to improve linkages to MOUD, supportive services, naloxone distribution, and harm reduction services for justice-involved individuals with OUD. The study will utilize a hub-and-spoke model to help unify the delivery of OUD treatment and harm reduction services across multiple counties in Illinois.
The University of Kentucky Hub (Staton et al., this issue) is studying the effectiveness of initiating treatment services through telehealth and peer navigation for justice-involved women with OUD as they transition from jail to the community. Through these services, participants will be able to engage with community health providers and peer navigators via telehealth platforms prior to release. The study will be conducted in nine jails across Kentucky, with the goal of increasing MOUD initiation and retention, while reducing relapse and overdose among high-risk justice-involved women in the community following release from jail.
The Yale University Hub (Clark et al., this issue) will assess whether the Transitions Clinic Network (TCN) program, which provides enhanced primary care and OUD treatment for people recently released from incarceration, improves services along the opioid treatment cascade. In TCN, community health workers with lived experience are embedded within primary care teams to address social determinants of OUD, provide social support, help patients build trust in the health system, and advocate in interactions with the criminal justice system. The intervention provides both a primary care home and support to address a variety of needs (including housing, food access, and social support) as individuals re-enter the community.
Three hubs test linkage strategies with an explicit organizational focus, with a goal of improving connections between justice systems and community-based treatment providers. The Brown University Hub (Rohsenow et al., this issue) uses facilitated local change teams consisting of justice and community service providers to develop and implement interorganizational linkage strategies. In a second stage, individuals under community supervision will be randomly assigned to receive assistance from peer support specialists vs. no peer support, allowing them to test the independent and combined effects of organizational and client-level linkage strategies on treatment engagement, retention, and outcomes.
The Texas Christian University (TCU) Hub (Knight et al., this issue) is testing two different strategies to implement an Opioid Treatment Linkage Model (O-TLM). This model is designed to improve interagency collaboration to better link individuals under community supervision with appropriate community-based treatment services. The study examines how best to implement this model, testing a traditional, top down “vertical implementation” approach, versus a phased “horizontal implementation” approach that allows for site-by-site testing and refinement. The study will assess whether individual treatment outcomes vary by the implementation approach.
The Indiana University School of Medicine Hub (Schwartz et al., this issue) focuses on interorganizational strategies to improve outcomes for justice-involved youth at high risk of developing substance use disorder. Their study seeks to implement a Learning Health System (LHS) model to improve collaboration between juvenile justice agencies and community mental health centers in Indiana, using interagency data-sharing to help identify gaps and opportunities to implement evidence-based interventions.
3.4. Implementation Strategies and Cross-Cutting Analyses
While the JCOIN hubs are testing a variety of interventions via effectiveness and hybrid designs, the JCOIN Coordination and Translation Center includes research capacity to identify effective implementation strategies for initiating MOUD services in correctional settings. In their study (Vechinski et al., this issue), the investigators conduct a head-to-head implementation trial to assess the independent and combined effects of a NIATx coaching strategy (to address process improvement at an organizational level) and the ECHO clinical mentoring strategy (for prescriber-level support).
Because costs are an essential concern for broad real-world scale up of these interventions, nearly all of the JCOIN studies include a cost component. In their article (Murphy et al., this issue), the team leading the economic analyses describes their approach to the collection and analysis of cost data for the individual studies, and opportunities for cross-cutting analyses to inform local decision-makers and policy makers.
Additional cross-cutting analyses will be facilitated by the use of a robust set of core measures that are common across all of the research hubs. The research teams agreed to integrate these common client-level measures into their protocols, covering a variety of domains including sociodemographics, substance use and overdose history, health status and infectious disease risk, pain and physical functioning, treatment receipt (including specific opioid medications), treatment preferences, and health services utilization. Projects collecting survey data from agency staff will also measure organizational climate related to implementation, and staff support for the use of evidence-based practices.
Complementing these clinical trials, the MAARC will conduct ongoing research on dynamic changes in policy and practice; develop simulation models that will explore hypotheses that are beyond the scope of any single clinical trial; leverage rigorous network modeling approaches to understand the influence of social networks on OUD recovery; use predictive analytics to forecast overdose rates; and employ innovative geospatial techniques to underscore the importance of MOUD service location on access to treatment. The vision for JCOIN is for “the whole to be more than the sum of the parts” – cross-cutting analyses, plus survey and modeling projects, will allow JCOIN to contextualize and extend the findings of the clinical trials described in this issue.
JCOIN researchers are also engaged in myriad other pilot and ancillary studies that include special populations, HIV and other co-occurring conditions, COVID-19 testing strategies, mHealth platforms, policy reviews, development of measures and methods, and more. Altogether, the current complement of JCOIN projects plan to engage agencies in 117 counties across 27 states and Puerto Rico, and anticipate reaching more than 40,000 justice-involved individuals – via direct enrollment of nearly 8,000 clients and 2,000 staff, and abstraction of more than 31,000 records of clients receiving services in these settings. (See Figure 2.) To ensure maximum reach of JCOIN’s findings, the CTC has created robust stakeholder networks of key justice and treatment organizations nationwide. Meanwhile, NIDA coordinates with other Federal and non-Federal funders who support complementary research in segments of the justice system that are not well represented in JCOIN trials (e.g., law enforcement, deflection/diversion programs, child welfare).
4.0. Adapting JCOIN Research to Address COVID-19 and Social Justice
As of this writing, COVID-19 continues to affect the U.S. in myriad ways. The collision of the novel coronavirus pandemic and the opioid epidemic create enormous challenges for individuals with OUD and the systems that treat them (Volkow, 2020). The justice system has been particularly impacted. As in other types of congregate living facilities, it is challenging or impossible for jails and prisons to maintain adequate physical distancing to avoid contagion, or to implement other preventive strategies such as facial coverings and frequent hand hygiene. Early release of non-violent detainees, reductions in new arrests and court trials, and restricted access to correctional facilities have raised significant logistical challenges for researchers working in these settings.
As described in the protocols in this special issue, JCOIN research teams are currently adapting their study designs and recruitment plans to meet these challenges. Close collaboration with justice and treatment agency partners has proven key to designing creative solutions that meet the needs of all involved. Where needed, additional study sites or recruitment options are being explored. All of the JCOIN protocols have made adaptations to incorporate videoconferencing and other virtual communication tools to engage study subjects at enrollment or for ongoing data collection. Many study sites quickly transitioned to telehealth services, to the reported benefit of both staff and patients. Policy changes have loosened the restrictions on initiating and maintaining patients on MOUD. These new flexibilities have introduced both clinical and research opportunities that were not possible when JCOIN was initially funded. Throughout the projects, the research teams will document the unique impacts of COVID-19 on patients and services, and capture important structural, practice, and policy changes that may emerge in the years following the current crisis. JCOIN will continue to engage stakeholders and collect policy and public opinion data to characterize the broader contexts in which these studies are conducted.
The pandemic has also exacerbated existing health disparities that disproportionally impact communities of color and disadvantaged populations. These inequities are a product of structural racism that exist within the criminal justice and health care systems. To meet the challenges of conducting impactful science in the context of the opioid epidemic, the COVID-19 pandemic, and heightened attention to issues of fundamental social justice, JCOIN’s research teams are working collectively to build an anti-racist consortium. Most JCOIN research hubs include BIPOC who have lived experience with OUD and/or incarceration; they are central to the studies’ interventions, working directly with justice-involved participants. The network continues to seek meaningful ways to give voice to these perspectives, and to shape how the research is conducted, interpreted, and disseminated. Additionally, inclusion of justice and treatment agency staff in the network’s steering committee, studies, and stakeholder boards permits a broader dialogue between decision-makers and the communities who are most directly impacted by those decisions. The network is exploring additional opportunities to thoughtfully and meaningfully increase BIPOC representation in JCOIN and increase diversity in justice research.
5.0. Conclusion
JCOIN represents an ambitious effort to conduct community-engaged research on interventions to address opioid misuse and OUD in justice populations. The protocols described in this issue will facilitate partnerships between researchers, local and state justice systems, and community-based treatment providers. Concurrent with these trials, other components of the network will conduct research on the most effective strategies for disseminating research findings to ensure rapid translation and implementation, and foster partnerships with a broad range of stakeholders to facilitate science-to-services translation. These efforts are designed to offer novel insights into addressing gaps in the continuum of care for justice-involved populations in the United States, while contributing to a broader effort to develop evidence-based strategies to address the opioid epidemic. If successful, these trials will offer actionable steps toward reducing the destructive impact of the opioid crisis, especially on our most vulnerable populations.
Highlights:
The opioid epidemic sits at the intersection of public health and public safety
Services for justice populations are needed across the opioid care cascade
JCOIN supports effectiveness, implementation, and hybrid study designs
Community-engaged research can speed translation of scalable solutions
ROLE OF THE FUNDING SOURCE:
Authors are extramural program staff at the National Institute on Drug Abuse, National Institutes of Health. Preparation of this manuscript was not supported by grant funds. The contents of this publication are solely the responsibility of the authors and do not represent the official views of NIDA or the NIH HEAL Initiative.
Footnotes
DECLARATION OF COMPETING INTERESTS: None
REFERENCES
- Blachman-Demner DR, Wiley TRA, & Chambers DA (2017). Fostering integrated approaches to dissemination and implementation and community engaged research. Translational Behavioral Medicine, 7(3):543–546. 10.1007/s13142-017-0527-8 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Bronson J, Stroop J, Zimmer S, & Berzofsky M (2017). Drug Use, Dependence, and Abuse Among State Prisoners and Jail Inmates, 2007–2009. Washington, DC: United States Department of Justice, Office of Justice Programs, Bureau of Justice Statistics. [Google Scholar]
- Bureau of Justice Statistics. (2020). Reentry Trends in the U.S. Retrieved from www.bjs.gov/content/reentry/reentry.cfm. Accessed December 7, 2020.
- Fiscella K, Wakeman SE, & Beletsky L (2018). Implementing opioid agonist treatment in correctional facilities. JAMA Internal Medicine, 178(9):1153–1154. 10.1001/jamainternmed.2018.3504 [DOI] [PubMed] [Google Scholar]
- Fox AD (2015). Opioid addiction and criminal justice systems: Opportunities to break the cycle of incarceration. SGIM Forum, 38(1). [Google Scholar]
- Gagne CA, Finch WL, Myrick KJ, & Davis LM (2018). Peer workers in the behavioral and integrated health workforce: Opportunities and future directions. American Journal of Preventive Medicine, 54(6):S258–S266. 10.1016/j.amepre.2018.03.010 [DOI] [PubMed] [Google Scholar]
- Green TC, Clarke J, & Brinley-Rubinstein L (2018). Postincarceration fatal overdoses after implementing medications for addiction treatment in a statewide correctional system. JAMA Psychiatry, 75(4):405–407. 10.1001/jamapsychiatry.2017.4614 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Holt C & Chambers DA (2017) Opportunities and challenges in conducting community-engaged dissemination/implementation research. Translational Behavioral Medicine, 7(3):389–392. 10.1007/s13142-017-0520-2 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Joudrey PJ, Khan MR, Wang EA, Scheidell JD, Edelman EJ McInnes DK. & Fox AD (2019). A conceptual model for understanding post-release opioid-related overdose risk. Addiction Science & Clinical Practice, 14(1):17. 10.1186/s13722-019-0145-5. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Leukefeld CG, Cawood M, Wiley T, Robertson AA, Fisher JH et al. (2017). The benefits of community and juvenile justice involvement in organizational research. Journal of Juvenile Justice, 6(1):112–124. [PMC free article] [PubMed] [Google Scholar]
- Marsden J, Stillwell G, Jones H, Cooper A, Eastwood B et al. (2017). Does exposure to opioid substitution treatment in prison reduce the risk of death after release? A national prospective observational study in England. Addiction, 112(8):1408–1418. 10.1111/add.13779 [DOI] [PubMed] [Google Scholar]
- Mears DP & Cochran JC (2012). U.S. prisoner reentry health care policy in international perspective: Service gaps and the moral and public health implications. Prison Journal, 92(2):175–202.https://doi.org/10.1177%2F0032885512438845 [Google Scholar]
- Moore KE, Roberts W, Reid H, Smith KMZ, & Oberleitner LMS (2018). Effectiveness of medication assisted treatment for opioid use in prison and jail settings: A meta-analysis and systematic review. Journal of Substance Abuse Treatment, 99:34–43. 10.1016/j.jsat.2018.12.003 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Volkow N (2020). Collision of the COVID-19 and addiction epidemics. Annals of Internal Medicine, 173(1), 61–62. 10.7326/M20-1212 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Williams AR, Nunes EV, Bisaga A, Levin FR, & Olfson M (2019). Development of a cascade of care for responding to the opioid epidemic. American Journal of Drug and Alcohol Abuse, 45:1–10. 10.1080/00952990.2018.1546862 [DOI] [PMC free article] [PubMed] [Google Scholar]