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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
Must not have
Women of child-bearing age will be excluded if they are pregnant
Require prescription opioids for acute pain, chronic pain or palliative care without OUD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months following jail release
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant.
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I need opioids for pain management and do not have opioid use disorder.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic procedure
Percent days of illicit opioid use
Therapeutic procedure
+1 more
Secondary study objectives
Death
Overdose
Retention in primary care
+1 more

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.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,907 Previous Clinical Trials
3,018,649 Total Patients Enrolled
2 Trials studying Opioid Addiction
23 Patients Enrolled for Opioid Addiction
University of North CarolinaOTHER
168 Previous Clinical Trials
1,450,641 Total Patients Enrolled
University of Puerto RicoOTHER
66 Previous Clinical Trials
21,786 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
~96 spots leftby Oct 2025
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