Testing MOUD Scale-Up

University of Wisconsin (UW)

Status: Not yet enrolling

Conditions: Correctional Institutions; Incarcerated Individuals

Treatments: Behavioral: Learning Collaborative; Behavioral: SAMHSA

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07224516

SO00004046 (Other Identifier)

1UM1DA064515-01 (U.S. NIH Grant/Contract)

CHESS (Other Identifier)

2025-1515

Protocol Version 10/10/2025 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Substance Abuse and Mental Health Services Administration (SAMHSA) Policy Academy

Experimental group

Description:

Departments of Corrections (DOCs) which previously completed the SAMHSA Policy Academy will be recruited for the Policy Academy.

Treatment:

Behavioral: SAMHSA

Multi-site Learning Collaborative (LC)

Experimental group

Description:

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.

Treatment:

Behavioral: Learning Collaborative

Practice as Usual

No Intervention group

Description:

This arm will conduct practice as usual, not using the updated MOUD practices.