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NCT04309565 · ClinicalTrials.gov registry record · NA
Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support
A NA study of Opioid Addiction, sponsored by Yale University.
- Active
- Registry status
- NA
- Development phase
- 400
- Enrollment target
- 5
- Study locations
NCT04309565: Active NA study of Opioid Addiction, sponsored by Yale University.
NCT04309565 is a NA study of Opioid Addiction that is active but no longer recruiting, run by Yale University. The registered enrollment target is 400 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04309565, a NA study of Opioid Addiction, is active but no longer recruiting, sponsored by Yale University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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,
Conditions Studied
Interventions
- BEHAVIORAL Transitions Clinic Network Primary Care
- BEHAVIORAL Standard Primary Care
Study Locations (5)
Connecticut
- Yale - New Haven
Minnesota
- Hennepin Healthcare - Minneapolis
New York
- Albert Einstein College of Medicine - The Bronx
North Carolina
- UNC Chapel Hill - Chapel Hill
Other
- University of Puerto Rico - San Juan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2021-04-21 |
| Est. Completion | 2025-12-30 |
| Phase | NA |
What the registry record for NCT04309565 still lists
NCT04309565 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Opioid Addiction appearing as the primary indexed condition, and to 2 interventions - of which Transitions Clinic Network Primary Care is the first listed.
NCT04309565 lists 5 locations in 5 states (Connecticut, Minnesota, New York).
Frequently Asked Questions
What is clinical trial NCT04309565 about?
NCT04309565 is a clinical study titled "Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support". 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 ye...
What is the current status of trial NCT04309565?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2021-04-21. Estimated completion is 2025-12-30.
What conditions does trial NCT04309565 study?
This clinical trial studies the following conditions: Opioid Addiction.
What interventions are being tested in trial NCT04309565?
The interventions under investigation include: Transitions Clinic Network Primary Care (BEHAVIORAL), Standard Primary Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT04309565?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04309565 being conducted?
This trial has 5 study locations across Connecticut, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04309565's enrollment target sits among peer trials
400 246th of 2000 higher than 1,734 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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