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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

No Placebo-Only Group

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 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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met