Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center

Addiction, Opioid Clinical Trial

— JCOIN_TCU  

Official title:

Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04276792
• Other study ID #: 1UG1DA050074
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: Texas Christian University
• Contact: Jennifer Becan, PhD
• Phone: 18172576518
• Email: j.becan[@]tcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are two study periods for the TCU JCOIN project. The primary aims of Study 1 (approved by the TCU IRB) are (1) to gather information from staff on the current treatment referral process within participating communities and (2) to learn about the existing interrelationships between medical and community behavioral health (CBH) providers. TCU IRB granted approval for Phase 1 on 11/07/19, approval number: 1920-60-AM1. Study 2 (under current review by the TCU IRB) includes recruitment across 18 community collaboration sites across 3 states; these communities will participate in the TCU Opioid-Treatment Linkage Model (O-TLM) protocol. The O-TLM is focused on best practices for improving screening, identifying and linking to MOUD providers, reducing stigma, and addressing other important factors that impact justice-involved individuals returning to their communities. Along with their agency records, information collected from justice-involved individuals within the target communities will be examined to assess O-TLM impact on improving public health and public safety outcomes. Furthermore, stakeholder staff across community organizations, including criminal justice and treatment agencies, will be asked to complete surveys on the O-TLM regarding its acceptability and adoption, as well as on best training strategies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• client level participant eligibility includes having a history of opioid use or at risk for opioid use; being released to a participating community while under supervision
• staff level participant eligibility includes being a key member of a participating community and involved in the service assessment and referral process of justice-involved individuals.

Exclusion Criteria:

• no history of opioid use or being at risk of opioid use; not being released to a participating community.
• staff level participant exclusion criteria include not being a key member of a participating community and not being involved in the service assessment and referral process of justice-involved individuals.

Related Conditions & MeSH terms

• Addiction, Opioid
• Opioid-Related Disorders

Intervention

Behavioral:
• TCU Opioid-Treatment Linkage Model (O-TLM)
The O-TLM is focused on best practices for improving screening, identifying and linking to MOUD providers, reducing stigma, and addressing other important factors that impact justice-involved individuals returning to their communities.

Locations

Country	Name	City	State
United States	Texas Christian University	Fort Worth	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Texas Christian University	Loyola University, University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Public Health assessed by decrease in days and amount of illicit drug use, including opioids	decreases in days and amount of illicit drug use, including opioids assessed through client interviews using the timeline follow-back method	6 months and 12 months post-release
Primary	Public Safety as assessed through reduction in rearrest rates	reductions in rearrest rates measured through justice and department of pubic safety records	6 months and 12 months post-release
Primary	Increase in Access to Services	referral rate increase as self-reported through client interviews and provided through justice records	6 months and 12 months post-release
Primary	Increase in Retention in Services	appointments kept as self-reported through client interviews and provided through justice and provider records	6 months and 12 months post-release
Secondary	Systems Impact as assessed through improved intervention attitudes	staff attitudes of intervention acceptability as assessed through survey	6 and 12 months post implementation start
Secondary	Systems Impact as assessed through intervention cost	accumulated cost of intervention	6 and 12 months post implementation start