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NCT Number: NCT07224516

Testing MOUD Scale-Up

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.

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Key information

Conditions

Incarcerated Individuals Correctional Institutions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

Location status: Recruiting

Location contact

Jessica Vechinski

CONTACT

[email protected]

414-899-4324

Rosemarie Martin, PhD

PRINCIPAL_INVESTIGATOR

Todd Molfenter, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAMHSA

Behavioral

Implement the scale-up of MOUD

Learning Collaborative

Behavioral

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.

Primary outcomes

  1. Reach of systems-change for scaling medications for MOUD

    Time frame: 2 years

    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

Secondary outcomes

  1. Effectiveness of systems-change approach for scaling MOUD

    Time frame: 2 years

    Using the RE-AIM framework, effectiveness is measured by the number of disciplinary infractions and individuals participating in SUD programming

  2. Adoption of systems-change approach for scaling MOUD

    Time frame: 2 years

    Using the RE-AIM framework, adoption is measured as the percentage of prisons that use buprenorphine, methadone, and/or naltrexone

  3. Implementation - IMAT Index

    Time frame: 2 years

    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.

  4. Implementation - Cascade of Care

    Time frame: 2 years

    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.

  5. Implementation - EBI checklist

    Time frame: 2 years

    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.

  6. Implementation - Partnering

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Vechinski, MSW

CONTACT

[email protected]

414-899-4324

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Testing MOUD Scale-Up Strategies in Criminal Legal Settings

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 4, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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