Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support

NCT04309565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2026-05-12

No results posted yet for this study

Summary

TCN PATHS will recruit an anticipated 400 participants who are prescribed MOUD who are released from detention facilities. Each individual will be randomized to either 1) standard primary care (SPC) or 2) a Transitions Clinic Network (TCN) program primary care. Participants will be followed for a year and complete surveys at baseline and at month 1, 3, 6, 9, and 12. At each of these points research staff will confirm MOUD status. Urine drug screenings will be completed at baseline, month 1, 6, and 12 if the participant is not incarcerated. When possible, research staff will collect electronic health records.

Conditions

Interventions

BEHAVIORAL

Transitions Clinic Network Primary Care

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.

BEHAVIORAL

Standard Primary Care

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.

Sponsors & Collaborators

  • University of North Carolina

    collaborator OTHER
  • University of Puerto Rico

    collaborator OTHER
  • University of Rochester

    collaborator OTHER
  • University of Miami

    collaborator OTHER
  • University of California, San Francisco

    collaborator OTHER
  • University of Connecticut

    collaborator OTHER
  • Albert Einstein College of Medicine

    collaborator OTHER
  • Hennepin Healthcare Research Institute

    collaborator OTHER
  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • Yale University

    lead OTHER

Principal Investigators

  • Emily Wang, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2025-10-30
Completion
2025-12-30

Countries

  • United States
  • Puerto Rico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04309565 on ClinicalTrials.gov