- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04276792
Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center (JCOIN_TCU)
February 9, 2023 updated by: DanicaKnight, Texas Christian University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer Becan, PhD
- Phone Number: 18172576518
- Email: j.becan@tcu.edu
Study Locations
-
-
Texas
-
Fort Worth, Texas, United States, 76109
- Recruiting
- Texas Christian University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- client level participant eligibility includes having a history of opioid use or at risk for opioid use after release; 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Horizontal implementation approach
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.
|
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.
|
ACTIVE_COMPARATOR: Vertical implementation approach
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Public Health assessed by decrease in days and amount of illicit drug use, including opioids
Time Frame: 6 months and 12 months post-release
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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
|
Public Safety as assessed through reduction in rearrest rates
Time Frame: 6 months and 12 months post-release
|
reductions in rearrest rates measured through justice and department of pubic safety records
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6 months and 12 months post-release
|
Increase in Access to Services
Time Frame: 6 months and 12 months post-release
|
referral rate increase as self-reported through client interviews and provided through justice records
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6 months and 12 months post-release
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Increase in Retention in Services
Time Frame: 6 months and 12 months post-release
|
appointments kept as self-reported through client interviews and provided through justice and provider records
|
6 months and 12 months post-release
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systems Impact as assessed through improved intervention attitudes
Time Frame: 6 and 12 months post implementation start
|
staff attitudes of intervention acceptability as assessed through survey
|
6 and 12 months post implementation start
|
Systems Impact as assessed through intervention cost
Time Frame: 6 and 12 months post implementation start
|
accumulated cost of intervention
|
6 and 12 months post implementation start
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Danica K Knight, PhD, Texas Christian University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 7, 2021
Primary Completion (ANTICIPATED)
May 31, 2023
Study Completion (ANTICIPATED)
April 30, 2024
Study Registration Dates
First Submitted
February 14, 2020
First Submitted That Met QC Criteria
February 17, 2020
First Posted (ACTUAL)
February 19, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 10, 2023
Last Update Submitted That Met QC Criteria
February 9, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1UG1DA050074 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Will adhere to NIH JCOIN approved plan
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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