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

N/A
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

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.

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

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for opioid addiction include medications such as methadone, buprenorphine, and extended-release naltrexone. Methadone is a full opioid agonist that reduces cravings and withdrawal symptoms by activating opioid receptors in the brain without producing the euphoria associated with opioid misuse. Buprenorphine is a partial opioid agonist that similarly alleviates withdrawal symptoms and cravings but with a ceiling effect that lowers the risk of misuse. Extended-release naltrexone is an opioid antagonist that blocks the effects of opioids, preventing any euphoric and sedative effects. These treatments are crucial for opioid addiction patients as they help stabilize brain chemistry, reduce illicit opioid use, and support recovery. For justice-involved individuals, these medications, when combined with comprehensive care models like O-TLM, improve treatment adherence, reduce stigma, and address specific challenges such as reintegration into the community.
The Predictive Value of Degree of Preference for Extended-Release Naltrexone for Treatment Adherence, Opioid Use, and Relapse.A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial.The effectiveness of opioid substitution treatments for patients with opioid dependence: a systematic review and multiple treatment comparison protocol.

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
376 Previous Clinical Trials
3,528,639 Total Patients Enrolled
Loyola UniversityOTHER
156 Previous Clinical Trials
31,083 Total Patients Enrolled

Media Library

TCU Opioid-Treatment Linkage Model (O-TLM) Clinical Trial Eligibility Overview. Trial Name: NCT04276792 — N/A
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 — N/A
TCU Opioid-Treatment Linkage Model (O-TLM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04276792 — N/A
~7 spots leftby Apr 2026