Specialized Post-Incarceration Care for Opioid Addiction

(TCN-PATHS Trial)

Not currently recruiting at 5 trial locations

Overseen By Aaron Fox, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: MOUD

Disqualifiers: Psychotic, Suicidal, Homicidal, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to support individuals with opioid addiction after release from jail or prison. It examines two methods: regular primary care and the Transitions Clinic Network, a special program offering tailored support such as medication for addiction and assistance from community health workers. The trial aims to determine which approach better helps individuals stay on their medication and avoid relapse. It is suitable for those diagnosed with opioid use disorder who are being released from a detention facility. Participants will complete surveys and undergo drug screenings over a year to track their progress. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance support systems for others in similar situations.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, since participants are required to be on MOUD (medications for opioid use disorder), it seems you may need to continue those medications.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must be on MOUD (medications for opioid use disorder), so you may need to continue those.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in this study, such as buprenorphine and extended-release naltrexone (XR-NTX), are generally safe and well-tolerated by patients. These medications have treated opioid use disorder in other settings and have a strong safety record.

Buprenorphine is safe for many people, though some may experience mild side effects like headaches or nausea. Extended-release naltrexone is also considered safe, but some users might have reactions at the injection site or mild flu-like symptoms.

The Transitions Clinic Network model, included in this study, offers comprehensive care by supporting people with both medical treatment and social services. While specific safety data for this model is limited, it builds on treatments already known to be safe.

Overall, both treatments in this study have a history of being well-tolerated. Participants considering joining the trial can feel reassured by these established safety records. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Transitions Clinic Network (TCN) Primary Care because it offers a comprehensive approach to caring for individuals with opioid addiction after incarceration. Unlike standard primary care, TCN integrates support for social determinants of health, such as housing and employment, through Community Health Workers, which can make a big difference in recovery. This model also focuses on reducing discrimination and stigma associated with past incarceration, which is often a barrier to effective treatment. By combining medical care with community support and addressing broader social issues, TCN aims to improve outcomes for those struggling with opioid addiction.

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

Research has shown that the Transitions Clinic Network (TCN) program, which participants in this trial may receive, helps people with opioid use disorder (OUD) continue their treatment after leaving jail. Studies indicate that TCN’s enhanced primary care, combined with support from community health workers, addresses both medical and social needs. This approach has successfully kept people engaged in their OUD treatment. TCN programs provide medications like buprenorphine and extended-release naltrexone, which have been proven to help manage OUD. Overall, the TCN program offers comprehensive care that addresses both health and social challenges faced by people after incarceration. Meanwhile, participants in the standard primary care arm will receive referrals to primary care and community Opioid Treatment Programs, where they may also receive buprenorphine or extended-release naltrexone. ^{1 2 3 4 6}

Who Is on the Research Team?

Emily Wang, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Opioid Use Disorder (OUD) who are on medication-assisted treatment and have been recently released from jail. Participants must speak English or Spanish, not be planning to relocate soon, and can't already have a primary care provider. Pregnant women or those needing opioids for pain management without OUD are excluded.

Inclusion Criteria

I can speak English or Spanish.

Meeting current DSM-5 criteria for OUD

Exclusion Criteria

Acutely psychotic, suicidal or homicidal

Have a planned relocation that makes it unlikely they would be able to complete the study and follow-up assessments

Have a primary care provider that they already have established care with in the community

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment

Participants complete the enrollment process while in jail, including recruitment, screening, consent, baseline assessments, and randomization

1-2 weeks

Treatment

Participants receive either standard primary care or Transitions Clinic Network (TCN) program primary care, with follow-up surveys and urine drug screenings at specified intervals

12 months

Visits at baseline, month 1, 3, 6, 9, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment, including engagement and retention in OUD treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Standard Primary Care
• Transitions Clinic Network Primary Care

Trial Overview The study compares two types of post-incarceration care: standard primary care versus Transitions Clinic Network (TCN) program primary care. The goal is to see which better supports individuals with OUD in maintaining their treatment. Participants will be randomly assigned to one of the groups and followed for a year.

How Is the Trial Designed?

Group I: Transitions Clinic Network Primary Care Experimental Treatment 1 Intervention

Transitions Clinic Network (TCN)- participants in this arm will be referred to a TCN program for primary care and community Opioid Treatment Program (OTP). All TCN programs have the ability to prescribe buprenorphine and Extended-release naltrexone (XR-NTX) and assist with referrals to methadone. The primary features of the TCN include (1) primary care and onsite MOUD or referral to community treatment when indicated, (2) addressing social determinants of OUD and care coordination through a Community Health Worker (CHW), and (3) addressing the discrimination and stigma that exist based on incarceration.

Group II: Standard Primary Care Active Control 1 Intervention

Those randomized to the standard primary care arm will be referred to primary care and community Opioid Treatment Program (OTP). Participants may receive buprenorphine or Extended-release naltrexone (XR-NTX) through primary care or with a community addiction treatment provider.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

University of Puerto Rico

Collaborator

Trials

69

Recruited

22,300+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of Connecticut

Collaborator

Trials

194

Recruited

162,000+

Albert Einstein College of Medicine

Collaborator

Trials

302

Recruited

11,690,000+

Hennepin Healthcare Research Institute

Collaborator

Trials

94

Recruited

77,100+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study of 142 opioid-dependent adults, those released from jail and seeking buprenorphine treatment in primary care had similar treatment retention rates (37%) compared to those referred from the community (30%) over 48 weeks.

Both groups showed comparable rates of opioid misuse, indicating that primary care can effectively support opioid-dependent individuals, regardless of their incarceration status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine-naloxone maintenance following release from jail. Lee, JD., Grossman, E., Truncali, A., et al.[2021]

Surgeons often transition postoperative opioid prescribing to primary care physicians passively, which can lead to patients returning to surgeons due to unresolved pain issues, highlighting a need for better coordination of care.

The study identified key areas for improvement, including establishing clear guidelines for care coordination, utilizing support staff for active transitions, and promoting multidisciplinary collaboration among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative opioid prescribing is not my job: A qualitative analysis of care transitions. Klueh, MP., Sloss, KR., Dossett, LA., et al.[2020]

The Transitions Clinic Network (TCN) program, which provides enhanced primary care for chronically ill and older individuals recently released from prison, costs $54,394 annually, or $146 per participant per month, and is associated with significantly lower criminal justice system costs compared to those not in the program.

Investing in the TCN program is financially beneficial, yielding a return of $2.55 for every dollar spent, while Medicaid costs remain similar between participants in the TCN and those who did not receive TCN care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost savings of a primary care program for individuals recently released from prison: a propensity-matched study. Harvey, TD., Busch, SH., Lin, HJ., et al.[2022]

A primary care-based transition clinic (SPARC) for patients starting buprenorphine for opioid use disorder showed significantly better treatment retention rates compared to usual primary care, with 90% retention at 1 month versus 60% in the usual care group.

Patients referred to SPARC had higher rates of attending initial visits (58% vs 38%) and received better quality care, including 100% naloxone provision and 81% infectious disease screening, indicating that multidisciplinary clinics can enhance care for those with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Primary Care-Based Multidisciplinary Transition Clinic for Patients Newly Initiated on Buprenorphine in the Emergency Department. Incze, MA., Sehgal, SL., Hansen, A., et al.[2023]

A randomized controlled trial involving 200 recently released prisoners showed that both Transitions Clinic and expedited primary care had similar rates of primary care engagement, with 37.7% and 47.1% respectively.

However, participants in the Transitions Clinic experienced significantly lower emergency department visits (25.5%) compared to those receiving expedited primary care (39.2%), indicating that a tailored care management program can effectively reduce acute care utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging individuals recently released from prison into primary care: a randomized trial. Wang, EA., Hong, CS., Shavit, S., et al.[2021]

The Transitions Clinic Network (TCN) successfully linked the California Department of Corrections and Rehabilitation with 21 primary care clinics, facilitating 8420 referrals for health care services to individuals released from prison between April 2020 and August 2022.

This initiative highlights the importance of care continuity and coordination, including data sharing and pre-release planning, as a model for improving health outcomes for formerly incarcerated individuals, especially in light of new policies like the Medicaid Reentry Act.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Reentry Health Care Hub: Creating a California-Based Referral System to Link Chronically Ill People Leaving Prison to Primary Care. Divakaran, B., Bloch, N., Sinha, M., et al.[2023]

In a study analyzing 368 nursing notes from 100 patients in an office-based opioid treatment program, nurses provided significant care coordination, which is crucial for improving outcomes in patients with opioid use disorder (OUD).

The analysis identified seven key areas of care coordination, such as medication management and patient education, highlighting the important role nurses play in supporting patients through medication-assisted treatment with buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Sensitive Indicators in the Care of Individuals With Opioid Use Disorder. Bernhardt, JM.[2023]

Among 751 patients studied, those referred to the Transitions Clinic Network (TCN) by correctional partners had fewer emergency department visits and hospitalizations in the year following their release compared to those referred by community partners, indicating the importance of coordinated care.

Early engagement in primary care after release was linked to increased acute care visits, suggesting that while timely access to health services is crucial, it may also lead to higher immediate health care utilization rather than reducing it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitions Clinic Network: Challenges And Lessons In Primary Care For People Released From Prison. Shavit, S., Aminawung, JA., Birnbaum, N., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8319218/

The Transitions Clinic Network: Post Incarceration ... Few interventions have successfully engaged and retained people with OUD in evidence-based addiction treatment after release from jail. · No randomized ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33583610/

A hybrid type-1 effectiveness trial of enhanced primary care to ... A hybrid type-1 effectiveness trial of enhanced primary care to improve opioid use disorder treatment outcomes following release from jail.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04309565

Transitions Clinic Network: Post Incarceration Addiction ... Purpose: The overall objective of this study is to assess whether the Transitions Clinic Network (TCN) program, which provides enhanced primary care and opioid ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547221000416

The Transitions Clinic Network: Post Incarceration ... Few interventions have engaged and retained people with OUD in evidence-based addiction treatment after release from jail.

5. medicine.yale.edu medicine.yale.edu/seiche/research/opioid-use-disorder/

Opioid Use Disorder - Yale School of Medicine The objective of TCN PATHS is to assess whether follow-up care in the Transitions Clinic Network (TCN), which provides OUD treatment and enhanced primary care.

6. aha.org aha.org/system/files/media/file/2025/07/oud-stud-transition-lit-review-2025.pdf

Bridge to Care This review synthesizes recent research on linkages and retention in care for patients with OUD and StUD, searched for as “care transitions,” as prepared by the ...