MOUD for Opioid Addiction in Incarcerated Individuals

Overseen By Jessica Vechinski, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must be taking: Opioid use disorder medications

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the health of incarcerated individuals struggling with opioid addiction by testing methods to increase the use of medications for opioid use disorder (MOUD). The researchers will explore different approaches, such as training sessions and policy changes, to determine which methods work best in a prison setting. The trial seeks correctional facilities interested in adopting or expanding MOUD programs and willing to support this initiative with necessary resources. As an unphased trial, participants can contribute to pioneering research that may lead to significant improvements in addiction treatment within correctional facilities.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this method is safe for incarcerated individuals?

Research has shown that medications for opioid use disorder (MOUD) are safe and generally well-tolerated. Studies indicate that people who take MOUD while in prison have a much lower risk of overdose after release. For instance, treatments like methadone and buprenorphine can reduce the risk of overdose death by up to 80% immediately after leaving prison.

Furthermore, individuals who receive MOUD are 85% less likely to die from an overdose in the first month after release. This evidence suggests that these treatments are not only effective but also safe for most people. While any medication can have side effects, these treatments have been proven to save lives during this critical period. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to scale up Medication for Opioid Use Disorder (MOUD) in incarcerated individuals, an area often overlooked in addiction treatment. Unlike the standard approach, which may not fully integrate MOUD in correctional settings, this trial includes a Multi-site Learning Collaborative that delivers ongoing training and support to reduce stigma and improve MOUD implementation. Another arm focuses on the SAMHSA Policy Academy, aiming to leverage previous policy work to enhance treatment practices. By addressing barriers and promoting broader acceptance and use of MOUD, the trial aims to improve outcomes for a population in critical need of effective addiction treatment.

What evidence suggests that this trial's treatments could be effective for opioid addiction?

Research has shown that providing medications for opioid use disorder (MOUD) in jails can greatly improve the health of individuals dealing with addiction. This trial will include participants in different study arms to evaluate the effectiveness of MOUD implementation strategies. Studies have found that individuals who receive MOUD while in jail are 52% less likely to die from an opioid overdose and 24% less likely to experience a non-fatal overdose. Additionally, treatments like methadone and buprenorphine are the most effective at preventing opioid overdoses. Increasing access to these medications in jails can lead to better treatment participation and fewer overdose deaths. ^{1 3 6 7 8}

Who Is on the Research Team?

Todd Molfenter, PhD

Principal Investigator

University of Wisconsin, Madison

Rosemarie Martin, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for leaders in the criminal justice system who want to increase the use of medications for opioid use disorder (MOUD) in prisons. Participants must have funding for medication, leadership support, and agree to implement at least one MOUD. They also need to sign a memorandum of understanding and provide data.

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

Exclusion Criteria

Failure to meet eligibility criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of systems-change approach using policy academy and multisite learning collaborative to scale MOUD across prisons

12 months

Monthly coaching sessions

Follow-up

Participants are monitored for the reach, effectiveness, and adoption of MOUD systems-change approach

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Testing MOUD Scale-Up

Trial Overview The study aims to scale up the use of MOUD within prisons using methods from SAMHSA's Learning Collaborative. It seeks cost-effective strategies that can be widely adopted across the criminal justice system to improve health outcomes for incarcerated individuals with opioid addiction.

How Is the Trial Designed?

Group I: Substance Abuse and Mental Health Services Administration (SAMHSA) Policy Academy Experimental Treatment 1 Intervention

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

Group II: Multi-site Learning Collaborative (LC) Experimental Treatment 1 Intervention

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 III: Practice as Usual Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07224516

Study Details | NCT07224516 | Testing MOUD Scale-Up This trial will evaluate a systems-change approach to scaling medications for opioid use disorder (MOUD) across 120 prisons in 12 U.S. states.

2. nih.gov nih.gov/news-events/news-releases/treating-opioid-addiction-jails-improves-treatment-engagement-reduces-overdose-deaths-reincarceration

Treating opioid addiction in jails improves treatment ... The study also found that receiving MOUD in jail was associated with a 52% lower risk of fatal opioid overdose, a 24% lower risk of non-fatal ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875923003004

Expanding access to Medication for Opioid Use Disorder ... This study included 375 unique individuals who received MOUD treatment at the jail between January 19, 2019, and the end of December 2020, with 56.2 % ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823908

Availability of Medications for Opioid Use Disorder in US Jails In this survey study of 1028 jails, less than half of jails (43.8%) offered medications for opioid use disorder to at least some individuals.

5. naco.org naco.org/resource/osc-incarcerated-pops

Effective Treatment for Opioid Use Disorder ... Treatment with MOUD — specifically, with methadone or buprenorphine — is the most effective way to prevent opioid overdose among people living with OUD ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11128549/

Access to medications for opioid use disorder for formerly ... Formerly incarcerated individuals receiving MOUD are 85% less likely to die from drug overdose in the first month after release and have a 32% ...

7. healthandjusticejournal.biomedcentral.com healthandjusticejournal.biomedcentral.com/articles/10.1186/s40352-025-00317-9

Medication for opioid use disorder service delivery in carceral ... Methadone and buprenorphine treatment for OUD during incarceration is associated with an 80% reduction in overdose mortality risk for the first ...

8. nga.org nga.org/wp-content/uploads/2021/02/NGA-Roadmap-on-MOUD-for-People-in-the-Justice-System_layout_final.pdf

Expanding Access to Medications for Opioid Use Disorder in Access to MOUD in correctional settings and facilitating access to services when reentering the community is an effective intervention for reducing overdoses ...