Testing MOUD Scale-Up

NCT ID: NCT07224516

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2028-08-31

Brief Summary

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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

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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.

Conditions

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Incarcerated Individuals Correctional Institutions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SAMHSA

Intervention Type BEHAVIORAL

Implement the scale-up of MOUD

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.

Group Type EXPERIMENTAL

Learning Collaborative

Intervention Type 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.

Practice as Usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SAMHSA

Implement the scale-up of MOUD

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Todd Molfenter, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Rosemarie Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin-Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

Central Contacts

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Jessica Vechinski, MSW

Role: CONTACT

414-899-4324

Facility Contacts

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Jessica Vechinski

Role: primary

414-899-4324

Other Identifiers

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1UM1DA064515-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Protocol Version 10/10/2025

Identifier Type: OTHER

Identifier Source: secondary_id

SO00004046

Identifier Type: OTHER

Identifier Source: secondary_id

CHESS

Identifier Type: OTHER

Identifier Source: secondary_id

2025-1515

Identifier Type: -

Identifier Source: org_study_id

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