TCU Opioid-Treatment Linkage Model for Opioid Addiction

(JCOIN_TCU Trial)

Overseen By Jennifer Becan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas Christian University

Disqualifiers: No opioid use history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to connect individuals with opioid addiction to treatment providers. It aims to enhance the process of identifying those who need medication for opioid use disorder (MOUD) and facilitate their access to care, particularly for those involved with the justice system. The trial compares two approaches: one that fosters collaboration between different agencies and another that employs traditional top-down methods. Individuals with a history of opioid use or those at risk who are being released to certain communities may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions for opioid addiction treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the TCU Opioid-Treatment Linkage Model (O-TLM) protocol is safe?

Research shows that specific safety information for the TCU Opioid-Treatment Linkage Model (O-TLM) is not yet available. This new method is still under testing and aims to improve the connection of individuals with opioid addiction to treatment.

This trial differs from typical drug trials, which usually test a new drug's safety. Instead, it evaluates how effectively this model can be applied in real-life situations, aiming to enhance public health and safety for those involved with the justice system.

Although direct safety data is lacking, the model focuses on improving current practices and teamwork, generally indicating a low risk for participants. If the trial involved a new medication, more specific safety information would likely be available. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TCU Opioid-Treatment Linkage Model (O-TLM) because it offers a fresh approach to tackling opioid addiction by linking criminal justice and community health systems. Unlike traditional methods that rely on top-down directives, the Horizontal implementation approach emphasizes collaboration and stakeholder involvement to refine practices and overcome barriers. Additionally, the Vertical implementation approach uses a structured, hierarchical strategy to drive change through policy and regulatory shifts. These innovative approaches aim to create more effective, integrated systems for addressing opioid addiction, potentially leading to better patient outcomes and systemic improvements.

What evidence suggests that the TCU Opioid-Treatment Linkage Model is effective for opioid addiction?

Research has shown that the TCU Opioid-Treatment Linkage Model (O-TLM) aids people with opioid addiction by connecting them to treatment and recovery resources. This trial will compare two different implementation approaches of the O-TLM. The Horizontal implementation approach involves facilitated collaboration between the criminal justice system and community health services, which has improved access to care. The Vertical implementation approach uses a hierarchical structure and top-down regulatory changes to drive system change. Both approaches aim to reduce stigma and improve coordination among providers, enhancing public health and safety. This trial evaluates how these approaches can effectively help individuals receive the assistance they need. ^{1 2 3 6 7}

Who Is on the Research Team?

Danica K Knight, PhD

Principal Investigator

Texas Christian University

Are You a Good Fit for This Trial?

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.

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

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.

no history of opioid use or being at risk of opioid use; not being released to a participating community.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Study 1

Gather information from staff on the current treatment referral process and learn about interrelationships between medical and community behavioral health providers

6 months

Study 2

Recruitment across 18 community collaboration sites to participate in the TCU Opioid-Treatment Linkage Model (O-TLM) protocol

12 months

Follow-up

Participants are monitored for public health and safety outcomes, including reduction in rearrest rates and illicit drug use

12 months

What Are the Treatments Tested in This Trial?

Interventions

• TCU Opioid-Treatment Linkage Model (O-TLM)

Trial Overview 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.

How Is the Trial Designed?

Group I: Horizontal implementation approach Experimental Treatment 1 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 approach Active Control 1 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.

TCU Opioid-Treatment Linkage Model (O-TLM) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Suboxone for:

• Opioid use disorder
• Acute and chronic pain

Approved in European Union as Suboxone for:

• Opioid dependence

Approved in Canada as Suboxone for:

• Opioid use disorder

Who Is Running the Clinical Trial?

Texas Christian University

Lead Sponsor

Trials

31

Recruited

4,400+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Loyola University

Collaborator

Trials

161

Recruited

31,400+

Published Research Related to This Trial

A study involving 468 Medicaid-enrolled individuals found that a mobile engagement unit significantly increased access to outpatient substance use treatment services and methadone maintenance for those with opioid use disorder (OUD).

Participants transported by the mobile unit showed a 23 percentage point increase in outpatient treatment utilization and a 32 percentage point increase in methadone maintenance compared to those who accessed treatment through traditional referral routes, indicating the effectiveness of mobile units in connecting underserved populations to necessary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transporting to treatment: Evaluating the effectiveness of a mobile engagement unit. Stewart, RE., Shen, L., Kwon, N., et al.[2021]

A study involving 570 participants in a 24-week trial found that using an individualized treatment rule to assign either extended-release naltrexone (XR-NTX) or buprenorphine-naloxone (BUP-NX) could reduce the risk of relapse in opioid use disorder (OUD) by 12% compared to random assignment.

The findings suggest that a simple treatment strategy, such as assigning XR-NTX to homeless individuals and BUP-NX to those with stable housing, could effectively prevent relapses, with a number-needed-to-treat of 14 to prevent one relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing opioid use disorder treatment with naltrexone or buprenorphine. Rudolph, KE., Díaz, I., Luo, SX., et al.[2022]

In a study of 16,576 individuals entering opioid agonist treatment (OAT) for the first time, the 12-month cessation rate was found to be 58.4%, highlighting the need for improved retention strategies in OAT.

Key predictors of earlier cessation included treatment factors like private dosing points and buprenorphine medication, as well as social factors such as homelessness and outpatient treatment for drug use disorders, suggesting that addressing these issues could enhance retention in OAT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using administrative data to predict cessation risk and identify novel predictors among new entrants to opioid agonist treatment. Bharat, C., Degenhardt, L., Dobbins, T., et al.[2021]

In a study of 255,726 Veterans with opioid use disorder (OUD), 15.8% received buprenorphine medication treatment (B-MOUD), with a significant increase in treatment courses over time, from 1550 in 2007 to 8146 in 2018.

Patients receiving B-MOUD had a median treatment duration of 157 days, with 33.8% undergoing multiple treatment courses, indicating that B-MOUD is a commonly utilized and persistent treatment option for managing OUD in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine use and courses of care for opioid use disorder treatment within the Veterans Health Administration. Gordon, AJ., Saxon, AJ., Kertesz, S., et al.[2023]

The analysis identified the top 100 'critical access' medication opioid use disorder (MOUD) facilities across the continental U.S., highlighting that many are located in rural areas, which are often underserved in terms of addiction treatment.

A significant number of these critical access providers (77 out of 100) offer buprenorphine, while others provide naltrexone and methadone, indicating a diverse range of treatment options available, but also revealing that many regions rely heavily on a single provider for MOUD services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical access medication for opioid use disorder (MOUD) treatment facilities in the continental United States. Pollack, HA., Lee, F., Paykin, S., et al.[2023]

Opioid withdrawal therapy agents and conditions like toxic encephalopathy and socioeconomic issues significantly increase the risk of adverse opioid-related events (AOEs), with relative risks as high as 33.4 for withdrawal therapy.

Patients with socioeconomic or mental health challenges are at a greater risk for AOEs, highlighting the importance of considering these factors when developing targeted interventions to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Health Trajectories Leading to Adverse Opioid-Related Events. Gilson, AS., Chartash, D., Chang, D., et al.[2021]

The article introduces a comprehensive taxonomy of linkage facilitation services designed to help individuals with opioid use disorder (OUD) access treatment and recovery resources, addressing significant barriers to care.

Developed through expert consensus, the taxonomy includes eight key domains that outline the roles, activities, and goals of linkage services, aiming to standardize practices and improve research in the field of OUD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linkage facilitation services for opioid use disorder: Taxonomy of facilitation practitioners, goals, and activities. Hogue, A., Satcher, MF., Drazdowski, TK., et al.[2023]

The Hub and Spoke model significantly increased access to buprenorphine for patients with opioid use disorder, reaching 45.48% of patients over 2 years, with 78.85% receiving a prescription after initial intake.

Patients in the program were 2.44 times more likely to receive a buprenorphine prescription compared to those at a site without the Hub and Spoke model, indicating its effectiveness in improving treatment access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(RE-)AIMing for Rapid Uptake: Pilot Evaluation of a Modified Hub and Spoke Model of Medication for Opioid Use Disorder. Heavey, SC., Beehler, GP., Funderburk, J.[2023]

Implementing the Collaborative Care Model (CCM) in primary care for treating opioid use disorder (OUD) significantly increased the number of providers prescribing buprenorphine and the number of patients receiving treatment, demonstrating improved access to care.

The model not only effectively addressed OUD but also helped manage common psychiatric comorbidities like anxiety and depression, although some primary care providers remained hesitant to participate, indicating a need for further education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary treatment of opioid use disorder in primary care using the collaborative care model. Brackett, CD., Duncan, M., Wagner, JF., et al.[2022]

Medication treatment for opioid use disorder (MOUD) is effective in reducing opioid-related issues, but about half of patients stop treatment within a year, highlighting the need for better retention strategies.

Utilizing data science techniques, such as predictive modeling and natural language processing, can help personalize care and improve retention in MOUD by integrating diverse data sources, including electronic health records and social media.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using data science to improve outcomes for persons with opioid use disorder. Hayes, CJ., Cucciare, MA., Martin, BC., et al.[2023]

Patients with opioid use disorder (OUD) receiving integrated care at the Comprehensive Care Practice (CCP) had a significantly higher retention rate in buprenorphine treatment over 6 months (79% vs. 61%) compared to those treated at other facilities, indicating improved treatment adherence.

The integrated care model at CCP not only led to fewer hospital stays (0.22 vs. 0.41) but also resulted in lower overall healthcare costs ($10,942 vs. $13,097), demonstrating that combining primary care with OUD treatment can enhance patient outcomes and reduce healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of Buprenorphine Treatment with Primary Care: Comparative Effectiveness on Retention, Utilization, and Cost. Hsu, YJ., Marsteller, JA., Kachur, SG., et al.[2020]

Citations

1. ibr.tcu.edu ibr.tcu.edu/2025/10/

October 2025 - Institute of Behavioral Research The Institute of Behavioral Research has released new materials from the TCU Hub Opioid-Treatment Linkage Model (O-TLM), developed as part of ...

2. withpower.com withpower.com/trial/phase-opioid-related-disorders-4-2021-9dc4a

TCU Opioid-Treatment Linkage Model for Opioid Addiction The TCU Opioid-Treatment Linkage Model (O-TLM) may be effective as it helps people with opioid addiction access treatment and recovery resources, similar to how ...

3. ibr.tcu.edu ibr.tcu.edu/new-o-tlm-resources-available-for-public-health-and-public-safety-agencies/

New O-TLM Resources Available for Public Health and Public ... The Institute of Behavioral Research has released new materials from the TCU Hub Opioid-Treatment Linkage Model (O-TLM), developed as part of ...

4. ibr.tcu.edu ibr.tcu.edu/projects/current-projects/jcoin/

Justice Community Opioid Innovation Network (JCOIN): TCU ... The JCOIN study explores positive outcomes for justice-involved individuals and the systems associated with a multi-level hybrid implementation approach. This ...

5. researchgate.net researchgate.net/figure/TCU-model-for-treatment-process-and-outcomes_fig1_12147901

TCU model for treatment process and outcomes. A conceptual model of treatment process and outcome. In particular, we have developed cognitive and be- havioral assessments of several key ingredients.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547221000167

Justice community opioid innovation network (JCOIN) The Texas Christian University (TCU) hub (Knight et al., 2021, this issue) is testing two different strategies to implement an opioid treatment linkage model (O ...

7. reporter.nih.gov reporter.nih.gov/search/t_DGTlvie0qmS0mZjfvkIQ/project-details/9882684

(JCOIN): TCU Clinical Research Center The ultimate goal of the proposed project is to improve local community public health and safety outcomes for reentering justice- involved individuals.