NCT07224516

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
27mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Feb 2026Aug 2028

First Submitted

Initial submission to the registry

October 31, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

February 5, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

October 31, 2025

Last Update Submit

February 12, 2026

Conditions

Incarcerated IndividualsCorrectional Institutions

Keywords

Correctional staff

Outcome Measures

Primary Outcomes (1)

  • Reach of systems-change for scaling medications for MOUD

    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

    2 years

Secondary Outcomes (6)

  • Effectiveness of systems-change approach for scaling MOUD

    2 years

  • Adoption of systems-change approach for scaling MOUD

    2 years

  • Implementation - IMAT Index

    2 years

  • Implementation - Cascade of Care

    2 years

  • Implementation - EBI checklist

    2 years

  • +1 more secondary outcomes

Study Arms (3)

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

EXPERIMENTAL

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

Behavioral: SAMHSA

Multi-site Learning Collaborative (LC)

EXPERIMENTAL

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.

Behavioral: Learning Collaborative

Practice as Usual

NO INTERVENTION

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

Interventions

SAMHSABEHAVIORAL

Implement the scale-up of MOUD

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

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.

Multi-site Learning Collaborative (LC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Failure to meet eligibility criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53706, United States

RECRUITING

MeSH Terms

Interventions

United States Substance Abuse and Mental Health Services Administration

Intervention Hierarchy (Ancestors)

United States Public Health ServiceUnited States Dept. of Health and Human ServicesUnited States Government AgenciesFederal GovernmentGovernmentOrganizationsHealth Care Economics and Organizations

Study Officials

  • Todd Molfenter, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

  • Rosemarie Martin, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Vechinski, MSW

CONTACT

414-899-4324jvechinski@wisc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2025

First Posted

November 4, 2025

Study Start

February 5, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Locations

US(1)