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Specialized Post-Incarceration Care for Opioid Addiction (TCN-PATHS Trial)

N/A

Recruiting

Led By Emily Wang, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months following jail release

Awards & highlights

TCN-PATHS Trial Summary

This trial will compare two different types of care for people who are prescribed medication for opioid use disorder and who are released from detention facilities. 800 people will be followed for a year, and surveys and drug screenings will be used to track their progress.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on different types of healthcare services rather than medications, there aren't direct side effects like you'd expect from drugs. However, participants may experience varying levels of stress or anxiety related to the transition process and adherence to their ongoing opioid use disorder treatments.

TCN-PATHS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

TCN-PATHS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months following jail release

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months following jail release

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months following jail release for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Therapeutic procedure

Percent days of illicit opioid use

Therapeutic procedure

+1 more

Secondary outcome measures

Death

Overdose

Retention in primary care

+1 more

TCN-PATHS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Transitions Clinic Network Primary CareExperimental Treatment1 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 CareActive Control1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,851 Previous Clinical Trials

2,737,813 Total Patients Enrolled

2 Trials studying Opioid Addiction

23 Patients Enrolled for Opioid Addiction

University of North CarolinaOTHER

167 Previous Clinical Trials

1,449,227 Total Patients Enrolled

University of Puerto RicoOTHER

62 Previous Clinical Trials

20,430 Total Patients Enrolled

Media Library

Standard Primary Care Clinical Trial Eligibility Overview. Trial Name: NCT04309565 — N/A

Opioid Addiction Research Study Groups: Transitions Clinic Network Primary Care, Standard Primary Care

Opioid Addiction Clinical Trial 2023: Standard Primary Care Highlights & Side Effects. Trial Name: NCT04309565 — N/A

Standard Primary Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04309565 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current sample size of this medical trial?

"To adequately conduct this clinical trial, 800 suitable participants are required. The study is available to individuals that meet set inclusion criteria in multiple locations such as Albert Einstein College of Medicine in Bronx and University of Rochester in North carolina."

Answered by AI

What goals is this research endeavor aiming to accomplish?

"This 12-month study will assess the efficacy of opioid use disorder (OUD) treatment. Secondary objectives include tracking overdose events via self-report and healthcare records, participant mortality, as well as time to overdose for those enrolled in four out of six sites with access to administrative payer data from Medicaid."

Answered by AI

How many medical facilities are currently conducting this trial?

"The research team has identified 5 potential clinical trial sites, including Albert Einstein College of Medicine in Bronx, University of Rochester in Rochester and UNC Chapel Hill in Chapel Hill. Additionally, two other locations are being considered for the study."

Answered by AI

Are there available spots in this trial for potential candidates?

"This research endeavour is currently enrolling participants. Per the data on clinicaltrials.gov, the study was first introduced to the public on April 1st 2021 and recently revised May 18th 2022."

Answered by AI