Addiction, OpioidJCOIN_TCUNCT04276792
Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center
A study testing TCU Opioid-Treatment Linkage Model (O-TLM) in people with Addiction, Opioid, run by Texas Christian University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addiction, Opioid
- What is being tested?
- TCU Opioid-Treatment Linkage Model (O-TLM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2021to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Christian University
Fort Worth, Texas, 76109
Jennifer Becan, PhD, 817-257-6518, j.becan@tcu.edu
About this study
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.
- Conditions
- Addiction, Opioid
- Being tested
- TCU Opioid-Treatment Linkage Model (O-TLM)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCU Opioid-Treatment Linkage Model (O-TLM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Horizontal implementation approach | Experimental | 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. Receives: Behavioral: TCU Opioid-Treatment Linkage Model (O-TLM) |
| Vertical implementation approach | Active comparator | 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. Receives: Behavioral: TCU Opioid-Treatment Linkage Model (O-TLM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months and 12 months post-release
Public Safety as assessed through reduction in rearrest rates
reductions in rearrest rates measured through justice and department of pubic safety records
Measured: 6 months and 12 months post-release
Increase in Access to Services
referral rate increase as self-reported through client interviews and provided through justice records
Measured: 6 months and 12 months post-release
Increase in Retention in Services
appointments kept as self-reported through client interviews and provided through justice and provider records
Measured: 6 months and 12 months post-release
Secondary outcomes (2)
Systems Impact as assessed through improved intervention attitudes
staff attitudes of intervention acceptability as assessed through survey
Measured: 6 and 12 months post implementation start
Systems Impact as assessed through intervention cost
accumulated cost of intervention
Measured: 6 and 12 months post implementation start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start7 Oct 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addiction, OpioidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our design is a Hybrid Type 3 design with the primary aim to compare 2 implementation strategies, and a secondary aim to assess client-level outcomes associated with the trial; the design includes a cluster randomized parallel design with staggered starts
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Christian University
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, Loyola University
- Responsible party
- Principal investigator, DanicaKnight, Texas Christian University
- Investigators
- Danica K Knight, PhD, Principal investigator, Texas Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276792
- Sponsor's protocol ID
- 1UG1DA050074
- Acronym
- JCOIN_TCU
- Status last verified
- May 2024
- First submitted
- 14 Feb 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will adhere to NIH JCOIN approved plan
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center
- ClinicalTrials.gov ID
- NCT04276792
- Acronym / sponsor ID
- JCOIN_TCU / 1UG1DA050074
- Conditions
- Addiction, Opioid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Texas Christian UniversityUniversity, hospital or other
- Collaborators
- University of New Mexico, Loyola University
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Our design is a Hybrid Type 3 design with the primary aim to compare 2 implementation strategies, and a secondary aim to assess client-level outcomes associated with the trial; the design includes a cluster randomized parallel design with staggered starts
| Arm | Type | Receives |
|---|---|---|
| Horizontal implementation approach | Experimental | Behavioral: TCU Opioid-Treatment Linkage Model (O-TLM)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. |
| Vertical implementation approach | Active comparator | Behavioral: TCU Opioid-Treatment Linkage Model (O-TLM)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Horizontal implementation approach, Vertical implementation approach |
Primary outcome
Public Health assessed by decrease in days and amount of illicit drug use, including opioids
Time frame: 6 months and 12 months post-release
decreases in days and amount of illicit drug use, including opioids assessed through client interviews using the timeline follow-back method
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
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
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
2 secondary outcomes
Systems Impact as assessed through improved intervention attitudes
Time frame: 6 and 12 months post implementation start
Systems Impact as assessed through intervention cost
Time frame: 6 and 12 months post implementation start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Yes. Will adhere to NIH JCOIN approved plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danica K Knight, PhD principal investigator
Texas Christian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCU Opioid-Treatment Linkage Model (O-TLM) in people with Addiction, Opioid, run by Texas Christian University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Becan, PhD (18172576518, j.becan@tcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Public Health assessed by decrease in days and amount of illicit drug use, including opioids (time frame: 6 months and 12 months post-release). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.