Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN-PATHS)

Yale University

Status: Active, not recruiting

Conditions: Opioid Addiction

Treatments: Behavioral: Standard Primary Care; Behavioral: Transitions Clinic Network Primary Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04309565

2000027469

1UG1DA050072-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Standard Primary Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Primary Care

Transitions Clinic Network Primary Care

Experimental group

Description:

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.

Treatment:

Behavioral: Transitions Clinic Network Primary Care