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Testing MOUD Scale-Up

Testing MOUD Scale-Up Strategies in Criminal Legal Settings

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07224516
Enrollment
120
Registered
2025-11-04
Start date
2026-02-05
Completion date
2028-08-01
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incarcerated Individuals, Correctional Institutions

Keywords

Correctional staff

Brief summary

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.

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.

Interventions

BEHAVIORALSAMHSA

Implement the scale-up of MOUD

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.

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Reach of systems-change for scaling medications for MOUD2 yearsUsing the RE-AIM framework, reach is measured by number of MOUD (buprenorphine, methadone, injectable naltrexone) standardized medication units purchased by prisons in a state

Secondary

MeasureTime frameDescription
Effectiveness of systems-change approach for scaling MOUD2 yearsUsing the RE-AIM framework, effectiveness is measured by the number of disciplinary infractions and individuals participating in SUD programming
Adoption of systems-change approach for scaling MOUD2 yearsUsing the RE-AIM framework, adoption is measured as the percentage of prisons that use buprenorphine, methadone, and/or naltrexone
Implementation - IMAT Index2 yearsImplementation 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.
Implementation - Cascade of Care2 yearsUsing 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.
Implementation - EBI checklist2 yearsUsing 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.
Implementation - Partnering2 yearsUsing 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.

Countries

United States

Contacts

CONTACTJessica Vechinski, MSW
jvechinski@wisc.edu414-899-4324
PRINCIPAL_INVESTIGATORTodd Molfenter, PhD

University of Wisconsin, Madison

PRINCIPAL_INVESTIGATORRosemarie Martin, PhD

University of Wisconsin, Madison

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026