Testing MOUD Scale-Up

Testing MOUD Scale-Up Strategies in Criminal Legal Settings

The goal of this clinical trial is to improve health outcomes for incarcerated individuals by increasing medications for opioid use disorder (MOUD) use, using scalable and cost-effective methods that could be applied more broadly in the criminal justice system.

Study Overview

• Status: Recruiting
• Conditions: Incarcerated Individuals; Correctional Institutions
• Intervention / Treatment: Behavioral: SAMHSA; Behavioral: Learning Collaborative

Detailed Description

This trial will evaluate a systems-change approach to scaling medications for opioid use disorder (MOUD) across 120 prisons in 12 U.S. states. Researchers will test two promising, implementation strategies-policy academy and multisite learning collaborative-commonly used in healthcare, education, and community development. The focus on MOUD is driven by strong evidence of its efficacy, low penetration in prisons, significant health inequities among incarcerated populations, and the high risk of overdose deaths during reentry into the community.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Vechinski, MSW; Phone Number: 414-899-4324; Email: jvechinski@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • Recruiting
      • University of Wisconsin-Madison
      • Principal Investigator: Todd Molfenter, PhD
      • Contact: Jessica Vechinski; Phone Number: 414-899-4324; Email: jvechinski@wisc.edu
      • Principal Investigator: Rosemarie Martin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria - Sites:

• Have an interest in embedding or increasing the use of MOUD within their site
• Have the funds to pay for medication for the duration of the study (24 months)
• Agree to implement or continue the use of at least one medication for opioid use disorder
• Have leadership support at all levels including from Secretary of DOC, medical director, wardens, etc.
• Sign a memorandum of Understanding (MOU) or Information Sheet
• Agree to provide data described in the Information Sheet

Exclusion Criteria:

• Failure to meet eligibility criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Substance Abuse and Mental Health Services Administration (SAMHSA) Policy Academy; Departments of Corrections (DOCs) which previously completed the SAMHSA Policy Academy will be recruited for the Policy Academy.	Behavioral: SAMHSA; Implement the scale-up of MOUD
Experimental: Multi-site Learning Collaborative (LC); The LCs will include learning sessions at baseline and monthly coaching sessions thereafter in the 12 month intervention period to provide training and technical assistance on the study protocol, types of MOUD and their clinical effectiveness, strategies to reduce stigma towards MOUD, approaches to overcoming common MOUD implementation barriers, and strategies to increase use and reduce burden of MOUD.	Behavioral: Learning Collaborative; The LCs will include learning sessions at baseline and monthly coaching sessions thereafter in the 12 month intervention period to provide training and technical assistance on the study protocol, types of MOUD and their clinical effectiveness, strategies to reduce stigma towards MOUD, approaches to overcoming common MOUD implementation barriers, and strategies to increase use and reduce burden of MOUD.
No Intervention: Practice as Usual; This arm will conduct practice as usual, not using the updated MOUD practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach of systems-change for scaling medications for MOUD	Using the RE-AIM framework, reach is measured by number of MOUD (buprenorphine, methadone, injectable naltrexone) standardized medication units purchased by prisons in a state	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of systems-change approach for scaling MOUD	Using the RE-AIM framework, effectiveness is measured by the number of disciplinary infractions and individuals participating in SUD programming	2 years
Adoption of systems-change approach for scaling MOUD	Using the RE-AIM framework, adoption is measured as the percentage of prisons that use buprenorphine, methadone, and/or naltrexone	2 years
Implementation - IMAT Index	Implementation is measured by Integrating Medications for Addiction Treatment (IMAT) Index (prison level). IMAT is a tool for evaluating and improving how primary care and behavioral health programs integrate MOUD. The scoring ranges from "1-Not Integrated" to "5-Fully Integrated", with intermediate scores of 2 and 4 representing in-between stages. The total IMAT score is calculated by averaging all item scores. This results in a composite rating from 1 to 5, which represents the overall implementation quality.	2 years
Implementation - Cascade of Care	Using the RE-AIM framework, implementation is measured by Cascade of Care performance (prison level). Cascade of Care is a framework that tracks progress through different stages of healthcare, from initial contact (like screening or diagnosis) to successful treatment and long-term management. The cascade visualizes how many individuals successfully move from one stage to the next, highlighting points where they are lost from the system.	2 years
Implementation - EBI checklist	Using the RE-AIM framework, implementation is measured by Advancing Recovery Framework Implementation of an EBI Checklist (state level). This measure is structured around the Cascade of Care performance (state level), This model helps states assess and improve their treatment systems by tracking individuals' progress from diagnosis through recovery.	2 years
Implementation - Partnering	Using the RE-AIM framework, implementation is measured by the level of partnering between DOC and prisons. Measure focuses on the strength and consistency of partnerships between the Department of Corrections (DOC) and individual prisons to support the delivery of evidence-based practices for opioid use disorder.	2 years

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Todd Molfenter, PhD, University of Wisconsin, Madison; Principal Investigator: Rosemarie Martin, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: October 31, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Actual): November 4, 2025

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Correctional staff
• Additional Relevant MeSH Terms: Organizations; Health Care Economics and Organizations; United States Public Health Service; United States Dept. of Health and Human Services; United States Government Agencies; Federal Government; Government; United States Substance Abuse and Mental Health Services Administration
• Other Study ID Numbers: 2025-1515; 1UM1DA064515-01 (U.S. NIH Grant/Contract); Protocol Version 10/10/2025 (Other Identifier: UW Madison); SO00004046 (Other Identifier: UW Madison); CHESS (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No