NCT04309565

Brief 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.

Trial Health

58
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 21, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

4.5 years

First QC Date

March 12, 2020

Last Update Submit

February 9, 2025

Conditions

Opioid Addiction

Outcome Measures

Primary Outcomes (4)

  • Engagement in opioid use disorder (OUD) treatment

    The primary study outcome will be engagement in OUD treatment within 30 days of jail release, defined as treatment consistent with the American Society of Addiction Medicine's levels of care (1-4), which allows for a range of treatments and clinical settings consistent with patient's needs and preference (e.g., office-based providers of buprenorphine or naltrexone, OTPs, or intensive outpatient, inpatient, or residential treatments). Patients do not need to be receiving methadone, buprenorphine, or naltrexone formulations (MOUD) to be considered engaged in OUD treatment. This will be measured based on questions about engagement in OUD treatment. These responses will be used to calculate a count of participants engaged in OUD treatment. As appropriate, this information will be confirmed in the electronic health record or with the addiction treatment facilities after obtaining a signed release.

    30 days following jail release

  • Retention in OUD treatment

    Retention in community OUD treatment will defined in accordance with the American Society of Addiction Medicine's levels of care (1-4), which allows for a range of treatments and clinical settings consistent with patient's needs and preference (e.g., office-based providers of buprenorphine or naltrexone, OTPs, or intensive outpatient, inpatient, or residential treatments). Patients do not need to be receiving MOUD to be considered retained in OUD treatment. Consistent with our prior research, this will be measured based on a Yes/No question about engagement in OUD treatment from the Treatment Services Review (TSR). These responses will be used to calculate a count of participants engaged in OUD treatment. As appropriate, this information will be confirmed in the electronic health record or with the addiction treatment facilities after obtaining a signed release. Re-incarceration (and resumption of MOUD in jail) will not count as retained in community OUD treatment.

    12 months following jail release

  • Retention on medication for OUD (MOUD)

    Retention on MOUD will be defined as receipt of any of the 3 FDA approved medications for OUD (methadone, buprenorphine, naltrexone) within 7 days of the index date (release from jail/interview date) regardless of what MOUD participants were on at baseline prior to release. This measure will be collected by using self report and as appropriate, will confirm self-report in the electronic health record or with the addiction treatment facilities after obtaining a signed release.

    12 months following initial jail release

  • Percent days of illicit opioid use

    Investigators will measure percent days of illicit opioid use during study time frames. Investigators will measure this by asking the participant how many days during the study time frame have they used illicit opioids. A urine toxicology that is positive for illicit opioids on testing will count as three days of using illicit opioids. Using the data from the

    12 months following initial jail release

Secondary Outcomes (4)

  • Retention in primary care

    12 months following jail release

  • Overdose

    12 months following initial jail release

  • Time to Overdose

    12 months following initial jail release

  • Death

    12 months following initial jail release

Study Arms (2)

Standard Primary Care

ACTIVE COMPARATOR

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.

Behavioral: Standard Primary Care

Transitions Clinic Network Primary Care

EXPERIMENTAL

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: Transitions Clinic Network Primary Care

Interventions

Transitions Clinic Network Primary CareBEHAVIORAL

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.

Transitions Clinic Network Primary Care
Standard Primary CareBEHAVIORAL

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.

Standard Primary Care

Eligibility Criteria

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

You may qualify if:

  • years or older
  • English and Spanish-speaking,
  • Meeting current DSM-5 criteria for OUD

You may not qualify if:

  • acutely psychotic, suicidal or homicidal,
  • require prescription opioids for acute pain, chronic pain or palliative care without OUD,
  • 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,
  • women of child-bearing age will be excluded if they are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Yale

New Haven, Connecticut, 06511, United States

Location

Hennepin Healthcare

Minneapolis, Minnesota, 55404, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27510, United States

Location

University of Puerto Rico

San Juan, Puerto Rico

Location

Related Publications (1)

  • Howell BA, Puglisi L, Clark K, Albizu-Garcia C, Ashkin E, Booth T, Brinkley-Rubinstein L, Fiellin DA, Fox AD, Maurer KF, Lin HJ, McCollister K, Murphy S, Morse DS, Shavit S, Wang K, Winkelman T, Wang EA. The Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN-PATHS): A hybrid type-1 effectiveness trial of enhanced primary care to improve opioid use disorder treatment outcomes following release from jail. J Subst Abuse Treat. 2021 Sep;128:108315. doi: 10.1016/j.jsat.2021.108315. Epub 2021 Jan 29.

    PMID: 33583610DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Emily Wang, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Hybrid type I effectiveness-implementation trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 16, 2020

Study Start

April 21, 2021

Primary Completion

October 30, 2025

Study Completion

December 30, 2025

Last Updated

February 11, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)PR(1)