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TCU Opioid-Treatment Linkage Model for Opioid Addiction (JCOIN_TCU Trial)

Phase 2
Recruiting
Led By Danica K Knight, PhD
Research Sponsored by Texas Christian University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months and 12 months post-release
Awards & highlights

JCOIN_TCU Trial Summary

This trial is examining two different study periods in order to gather information on the referral process for treatment and to learn about the relationships between medical and communitybehavioral health providers.

Who is the study for?
This trial is for key community staff involved in service assessment and referrals, as well as individuals with a history of opioid use or at risk after release under supervision to participating communities. It excludes those not involved in referral processes or without opioid use risks.Check my eligibility
What is being tested?
The TCU JCOIN project tests the Opioid-Treatment Linkage Model (O-TLM), aiming to improve screening, linkage to treatment providers, reduce stigma, and enhance public health and safety outcomes among justice-involved individuals.See study design
What are the potential side effects?
Since this study focuses on improving service linkages rather than testing a medical intervention, it does not have traditional side effects. However, there may be indirect impacts on participants' experiences based on changes in service provision.

JCOIN_TCU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months and 12 months post-release
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 12 months post-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
Increase in Access to Services
Increase in Retention in Services
Public Health assessed by decrease in days and amount of illicit drug use, including opioids
+1 more
Secondary outcome measures
Systems Impact as assessed through improved intervention attitudes
Systems Impact as assessed through intervention cost

JCOIN_TCU Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Horizontal implementation approachExperimental Treatment1 Intervention
The Horizontal implementation approach of the O-TLM intervention is accompanied by facilitated collaboration between Criminal Justice and Community Behavioral Health systems. Direct involvement of stakeholders with differing perspectives and buy-in from agency leadership and policymakers are key elements. The Horizontal approach involves first developing a prototype (including how to modify existing practices, overcome implementation barriers, and manage roles and responsibilities) that are tested and refined before being rolled out systematically to other units within an agency.
Group II: Vertical implementation approachActive Control1 Intervention
The Vertical implementation approach of the O-TLM intervention relies on the traditional criminal justice system's typical use of a hierarchical structure and the use of a top-down implementation approach (i.e., administrative orders) for directing change. Top-down regulatory and policy changes are viewed as vital levers for driving system change.

Find a Location

Who is running the clinical trial?

Texas Christian UniversityLead Sponsor
27 Previous Clinical Trials
3,881 Total Patients Enrolled
University of New MexicoOTHER
371 Previous Clinical Trials
3,528,882 Total Patients Enrolled
Loyola UniversityOTHER
156 Previous Clinical Trials
30,904 Total Patients Enrolled

Media Library

TCU Opioid-Treatment Linkage Model (O-TLM) Clinical Trial Eligibility Overview. Trial Name: NCT04276792 — Phase 2
Opioid Addiction Research Study Groups: Horizontal implementation approach, Vertical implementation approach
Opioid Addiction Clinical Trial 2023: TCU Opioid-Treatment Linkage Model (O-TLM) Highlights & Side Effects. Trial Name: NCT04276792 — Phase 2
TCU Opioid-Treatment Linkage Model (O-TLM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04276792 — Phase 2

Frequently Asked Questions

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

How many people will be given the opportunity to participate in this clinical trial?

"Yes, the trial is currently ongoing and recruiting patients. It was first posted on October 7th 2021 and was last updated February 28th 2022. The study needs 18 more participants at 1 site."

Answered by AI

Are we still looking for people to participate in this research project?

"From what is published on clinicaltrials.gov, this clinical trial is still looking for test subjects. The original posting date was 10/7/2021 with the latest update on 2/28/2022."

Answered by AI

What are the dangers associated with TCU Opioid-Treatment Linkage Model (O-TLM)?

"While there is some data supporting the safety of TCU Opioid-Treatment Linkage Model (O-TLM), it falls into Phase 2 of clinical trials and has not yet been proven effective. Consequently, our team at Power rates its safety a 2."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Texas Christian University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I want to get help, and if what I go through helps teach y'all something, it's a win win.
PatientReceived no prior treatments
~5 spots leftby Mar 2025