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Recruiting NCT07224516

Testing MOUD Scale-Up

No phase Interventional Incarcerated Individuals Correctional Institutions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SAMHSA, Learning Collaborative.
Who it may be relevant to
Registry conditions: Incarcerated Individuals, Correctional Institutions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Testing MOUD Scale-Up Strategies in Criminal Legal Settings

Overview

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

  • Behavioral SAMHSA
    Implement the scale-up 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.

Primary outcome measures

  • Reach of systems-change for scaling medications for MOUD [Time frame: 2 years]
Secondary outcome measures (6)
  • Effectiveness of systems-change approach for scaling MOUD [Time frame: 2 years]
  • Adoption of systems-change approach for scaling MOUD [Time frame: 2 years]
  • Implementation - IMAT Index [Time frame: 2 years]
  • Implementation - Cascade of Care [Time frame: 2 years]
  • Implementation - EBI checklist [Time frame: 2 years]
  • Implementation - Partnering [Time frame: 2 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Wisconsin-Madison — Madison

Identifiers

NCT: NCT07224516 · 2025-1515 · 1UM1DA064515-01 · Protocol Version 10/10/2025 · SO00004046 · CHESS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗