Draft_jcoin phase II clinical research hub

The National Institute on Drug Abuse awarded University of Wisconsin-Madison a $5.014 million cooperative agreement (UM1DA064515) on September 15, 2025, to conduct a three-arm comparative effectiveness cluster randomized controlled trial evaluating systems change approaches to scaling medications for opioid use disorder (MOUD) across 120 prisons in 12 states through May 31, 2030, under the Drug Use and Addiction Research Programs (CFDA 93.279).

The award funds implementation science research testing two scale-up strategies—policy levers and multisite learning collaboratives—for expanding MOUD access in prison settings. The learning collaborative approach includes didactic education sessions followed by 12 months of monthly organizational coaching at the prison level. The trial capitalizes on a natural experiment within the Substance Abuse and Mental Health Services Administration's state-based policy academy, which provides technical assistance to state departments of corrections on policy lever bundles. Work is performed in Madison, Wisconsin.

University of Massachusetts Medical School (sub-award awarded February 23, 2026) provides expertise in implementation science and qualitative data analysis, develops and maintains qualitative data collection manuals, oversees data collection and analyses, assists with assessment creation, manages reimbursements, and liaisons with the Economic Research Resource Center. Weill Medical College of Cornell University (sub-award awarded January 29, 2026) conducts the comprehensive economic evaluation, calculating implementation costs and assessing economic value of MOUD scale-up relative to treatment as usual. George Mason University (sub-award awarded January 26, 2026) serves as expert on prison operations, works with the Correctional Leadership Association, develops standard practices for MOUD administration, examines existing site procedures and policies, and contributes to publications and dissemination.

Abstract

The translation GAP between evidence and practice that leaves many evidence-based innovations (ebis) underutilized is well recognized, prompting the development of implementation science. While the field has made notable progress in implementing practices with targeted individuals and organizations, IT has given less attention to and made slower progress across broader provider populations, limiting its overall impact on the translation GAP. This three-arm comparative effectiveness cluster randomized controlled trial will evaluate a systems change approach to scaling medications for opioid use disorder (moud) across 120 prisons in 12 states. Policy levers and multisite learning collaboratives, two promising, cost-effective, scale-up implementation approaches used in health care, education, and community development in developing countries, will be tested for their effectiveness in implementing moud in prison settings. This focus is driven by strong evidence supporting moud efficacy, poor moud penetration rates in prisons, existing health inequities within incarcerated populations, and the high risk of preventable overdose deaths for those transitioning from criminal legal settings to the community. Prisons were selected as the criminal justice setting (CJS) for this trial because they house 58.5% of the incarcerated population. The policy portion of the trial will capitalize on a natural experiment that exists in the substance abuse and mental health services administration (samhsa) state-based policy academy, which provides technical assistance to state departments of corrections (docs) on use of policy lever bundles to increase prison-based moud use. The learning collaborative will use a standardized approach, starting with didactic education sessions followed by monthly organizational coaching sessions for 12 months, focusing on prison level rather than DOC-level scale-up of moud. A RE-aim evaluation approach will be applied, with the primary aim based on reach, measured through standardized moud unit purchases that can provide an innovative way to measure moud use in each prison, clustered by state. The trial will compare the differential reach of a policy lever implemented through the policy academy with that of the learning collaborative, as well as the impact of contextual variables on both these strategies compared to practice as usual. In this complex environment where many factors can impact the uptake of an EBI, a sophisticated covariate strategy will be used to isolate scale-up treatment effects, and a qualitative and economic analysis will be used to interpret those effects. Overall, IT is estimated that increased use of moud in prison settings can reduce mortality and morbidity, lower healthcare costs, and improve quality of life. Scale-up and capacity-building activities to improve the delivery of ebis may be used at other key points in the sequential intercept model (SIM), which details how individuals with mental and substance use disorders come in contact with and move through the CJS. Both interventions being tested are replicable and, if successful, could significantly advance the translation and scale-up of ebis within CJS and beyond.