What side effects are associated with this type of intervention?

Common treatments for opioid addiction, such as methadone, buprenorphine, and naltrexone, have various side effects. Methadone can cause respiratory depression, constipation, sweating, and potential for dependency. Buprenorphine may lead to headaches, nausea, constipation, and insomnia. Naltrexone can cause gastrointestinal issues, headache, dizziness, and liver enzyme abnormalities. These treatments are effective but require careful monitoring to manage side effects and ensure patient safety.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of opioid addiction that align with the goals of the TCU Opioid-Treatment Linkage Model (O-TLM). These include methadone, buprenorphine, and naltrexone. Methadone and buprenorphine are used as part of Medication for Opioid Use Disorder (MOUD) programs, which are designed to reduce withdrawal symptoms and cravings. Buprenorphine, often combined with naloxone (as in Suboxone), is particularly noted for its use in outpatient settings and its ability to be prescribed by certified physicians, thus improving access and reducing stigma. Naltrexone, available in oral and extended-release injectable forms, works by blocking the euphoric effects of opioids. These treatments are integral to comprehensive care models that include behavioral therapies and support services, addressing the multifaceted needs of individuals, including those involved with the justice system.

What other types of research exist?

Promising novel alternatives to the TCU Opioid-Treatment Linkage Model (O-TLM) for opioid addiction patients include: 1) Expansion of Medication-Assisted Therapy (MAT) with a focus on harm reduction strategies, as suggested by the countering perspective to Fischer et al.'s view. 2) Implementation of comprehensive community-based programs that integrate medical and behavioral health services, as indicated by the Community Opioid Innovation Network (JCOIN) project. 3) Use of technology-driven solutions such as telemedicine for remote screening and counseling, which can enhance access to care and reduce stigma. 4) Development of personalized treatment plans based on genetic factors in pain and its treatment, which can improve the efficacy of opioid addiction treatments.

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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 testing a program that helps people who have been involved with the justice system get better access to opioid addiction treatment. It focuses on identifying those in need, connecting them to treatment providers, reducing stigma, and addressing other challenges they face when returning to their communities.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months and 12 months post-release

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

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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

29 Previous Clinical Trials

4,371 Total Patients Enrolled

University of New MexicoOTHER

383 Previous Clinical Trials

3,523,176 Total Patients Enrolled

Loyola UniversityOTHER

159 Previous Clinical Trials

31,241 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

~6 spots leftby Apr 2026

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