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

Last updated: February 9, 2025
Sponsor: Yale University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Substance Abuse

Opioid Use Disorder

Addictions

Treatment

Standard Primary Care

Transitions Clinic Network Primary Care

Clinical Study ID

NCT04309565
2000027469
1UG1DA050072-01
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years or older

  • English and Spanish-speaking,

  • Meeting current DSM-5 criteria for OUD

Exclusion

Exclusion Criteria:

  • acutely psychotic, suicidal or homicidal,

  • require prescription opioids for acute pain, chronic pain or palliative care withoutOUD,

  • have a planned relocation that makes it unlikely they would be able to complete thestudy and follow-up assessments,

  • have a primary care provider that they already have established care with in thecommunity,

  • women of child-bearing age will be excluded if they are pregnant

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Standard Primary Care
Phase:
Study Start date:
April 21, 2021
Estimated Completion Date:
December 30, 2025

Study Description

Purpose: The overall objective of this study is to assess whether the Transitions Clinic Network (TCN) program, which provides enhanced primary care and opioid use disorder (OUD) treatment for people recently released from incarceration, improves measures in the opioid treatment cascade compared to referral to standard primary care.

Participants: An anticipated 400 individuals currently receiving medications for OUD released from eight local jails (Durham, NC; Minneapolis, MN; Bronx, NY; Bridgeport and Niantic, CT; and Bayamón and Ponce, Puerto Rico)

Procedures: This is a hybrid type I effectiveness-implementation trial will randomize an anticipated 400 participants to one of two treatment conditions: TCN or standard primary care. People will complete the enrollment process while in jail (recruitment, screening, consent, baseline assessments, and randomization). Due to COVID-19 restrictions some jails are limiting researcher assess to people and some of our sites may enroll participants once they are released, this is referred to as a community enrollment. Post participants will meet with research assistants for a structured interview and urine toxicology screening at 1, 6, and 12 months, and a phone interview at months 3 and 9. 120 people will be selected to participate in Intensive Longitudinal Assessment (ILA) to access both the acceptability and appropriateness of the TCN intervention and the multi-level facilitators and barriers of OUD treatment engagement in the first 30 days following release from incarceration.

Connect with a study center

  • University of Puerto Rico

    San Juan,
    Puerto Rico

    Site Not Available

  • Yale

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Hennepin Healthcare

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Albert Einstein College of Medicine

    Bronx, New York 10467
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14627
    United States

    Site Not Available

  • UNC Chapel Hill

    Chapel Hill, North Carolina 27510
    United States

    Site Not Available

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