Integrated Care for Opioid Use Disorder

Overseen By Audun J Lier, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Severe disability, HIV, HBV

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new care model that combines treatment for opioid use disorder (OUD) with infectious disease care in a single VA clinic visit. The goal is to improve Veterans' health by providing a more convenient treatment plan that saves time and reduces costs. Participants will either continue with their usual care or try this integrated approach, which includes testing and prevention for infections like HIV and hepatitis. Veterans with a documented moderate to severe opioid use disorder who receive care at the Northport VA clinic can participate. As an unphased trial, this study offers Veterans the chance to contribute to innovative care solutions that could enhance their treatment experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this new care model is safe for Veterans?

Research has shown that integrated care for opioid use disorder (OUD) is generally well-received. Programs that address OUD alongside other health issues have been successful in previous studies. For instance, one study found that 85% of patients remained in the program for six months, and most had negative urine tests for opioids, indicating adherence to the treatment.

Reports from various integrated care programs indicate low rates of serious side effects, suggesting this approach is safe for most individuals. These programs often enhance overall health and effectively reduce illegal drug use and the risk of overdose.

While specific safety data for this trial is not yet available, integrated care has been safely used in similar situations, indicating a positive safety outlook for the treatment under investigation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Care approach for opioid use disorder because it offers a more holistic way to support patients compared to standard treatments focusing solely on substance use. Unlike traditional care, which often separates addiction treatment from other health services, Integrated Care combines addiction support with essential health screenings and preventive measures for infections like HIV and hepatitis. This method not only addresses opioid dependence but also proactively manages health risks, ensuring comprehensive care for individuals with opioid use disorder. By integrating these services, the approach aims to improve overall health outcomes and patient engagement in their treatment journey.

What evidence suggests that this integrated care model is effective for opioid use disorder?

Research has shown that combining treatment for opioid use disorder (OUD) and related infections can lead to better health outcomes. This trial will compare two approaches: integrated care and treatment as usual. Integrated care programs address both mental and physical health needs together, improving coordination and results in OUD treatment. For instance, medications like buprenorphine or methadone lower the risk of overdose and reduce the need for emergency medical care. Additionally, receiving proven treatments in a supervised setting, such as a clinic, helps decrease illegal drug use and the chance of overdose. Overall, integrated care offers hope for better health in people with OUD. ^{1 2 6 7 8}

Who Is on the Research Team?

Audun J Lier, MD

Principal Investigator

Northport VA Medical Center, Northport, NY

Are You a Good Fit for This Trial?

This trial is for Veterans with opioid use disorder (OUD) who are also at risk or suffering from infectious diseases like Hepatitis C, HIV/AIDS, and sexually transmitted infections. It aims to help those who typically attend multiple appointments for their conditions.

Inclusion Criteria

US Veteran

Able to provide written informed consent in English

Living in the community (Nassau, Suffolk, Kings, Queens, Bronx, Westchester, Rockland counties, NY)

Exclusion Criteria

Severe medical or psychiatric disability making participation unsafe

Unable to provide written consent

PrEP exclusion: HIV positive test; HBV positive test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive integrated care with infectious diseases screening and medication assisted therapy for opioid use disorder

90 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PrEP uptake and infectious diseases screening

270 days

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Care

Trial Overview

The study is testing a new care model that integrates treatment for OUD and various infectious diseases into one clinic appointment within the VA system, potentially improving health outcomes and efficiency.

How Is the Trial Designed?

Group I: Integrated care Experimental Treatment 1 Intervention

Study visit 1: Participants will first complete a study interview, then will receive a prescription for laboratory testing for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), gonorrhea, chlamydia, and syphilis. Those who meet eligibility criteria for PrEP will receive a prescription for PrEP (emtricitabine 200 mg (FTC)/25 mg tenofovir alafenamide-emtricitabine (TAF) or once daily emtricitabine 200 mg (FTC)/300 mg tenofovir disoproxil fumarate-emtricitabine (TDF)), and will be referred to the Infectious Diseases clinic for PrEP follow-up. Participants will then complete a standard SUD clinic appointment. Study visit 2: Participants will follow-up at 90 days in the SUD clinic where they will repeat the study interview, followed by receipt of standard SUD clinical care.

Group II: Treatment as usual Active Control 1 Intervention

Study visit 1: Participants will first complete a study interview, then will complete a standard SUD clinic appointment. After the SUD appointment, participants will be referred to the Infectious Diseases clinic to receive standard infectious diseases laboratory testing, including HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), gonorrhea, chlamydia, and syphilis. Those who meet eligibility criteria for PrEP will receive a prescription for PrEP (emtricitabine 200 mg (FTC)/25 mg tenofovir alafenamide-emtricitabine (TAF) or once daily emtricitabine 200 mg (FTC)/300 mg tenofovir disoproxil fumarate-emtricitabine (TDF) through the infectious diseases clinic. Study visit 2: Participants will follow-up at 90 days in the SUD clinic where they will repeat the study interview, followed by receipt of their standard SUD clinical care.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The study identified five distinct models of integrated care for families affected by opioid use disorder (OUD), emphasizing the need for supportive and frequent visits with various providers, although billing constraints hinder full integration of services.

Key components for effective dyadic care include prioritizing care coordination, overcoming barriers to integrate medical and behavioral services, and ensuring child safety while maintaining parental trust, highlighting the complexities of addressing both parental and infant health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for Families Impacted by Opioid Use: A Qualitative Analysis of Integrated Program Designs. Schiff, DM., Partridge, S., Gummadi, NH., et al.[2023]

Individuals with HIV who also use drugs face higher health risks compared to those without drug use, highlighting the need for integrated care models.

A systematic review of 22 studies revealed that while integrated HIV and opioid use disorder services exist, they often lack coordinated state-level policies and systems, suggesting that improved coordination and standardized tools could enhance service delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coordinating Systems of Care for HIV and Opioid Use Disorder: A Systematic Review of Enablers and Barriers to Integrated Service Access, and Systems and Tools Required for Implementation. Duffy, M., Ghosh, A., Geltman, A., et al.[2022]

A retrospective study showed that implementing data-based opioid risk reviews can potentially reduce serious adverse events (SAEs) related to opioid use, including overdoses and suicide-related events, in the 6 months following the review.

However, the study also found that tapering or discontinuing opioid therapy significantly increased the risk of suicide-related events and opioid-related SAEs, indicating that careful management is crucial during these processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data-Based Opioid Risk Review in Patients with Chronic Pain: A Retrospective Chart Review. Pogue, J., Lau, L., Boyer, J.[2023]

A review identified seven quality measures for treating opioid use disorder (OUD), all of which focus on the processes of service delivery, highlighting the need for better assessment of treatment outcomes and patient experiences.

There is a significant gap in quality measures specifically tailored for OUD, indicating that a unified framework, like an OUD Treatment Cascade, is necessary to improve care access and reduce opioid-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an opioid use disorder treatment cascade: A review of quality measures. Williams, AR., Nunes, EV., Bisaga, A., et al.[2022]

Only 2 out of 31 endorsed quality measures for opioid use disorder (OUD) considered patient preferences and needs, highlighting a significant gap in patient-centered care despite guidelines emphasizing its importance.

The study developed a new quality measurement taxonomy called EQuIITable Care, which includes six classifications aimed at improving patient-centered care in OUD treatment and identifying areas for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered quality measurement for opioid use disorder: Development of a taxonomy to address gaps in research and practice. Kelley, AT., Incze, MA., Baylis, JD., et al.[2023]

A qualitative study involving 22 patients, 24 clinical staff, and 5 clinic leaders identified key themes for improving the integration of HIV and opioid use disorder (OUD) care, emphasizing the need to address social risks and knowledge gaps about treatments.

The development of a new measurement tool based on these insights aims to enhance service delivery for patients with HIV and OUD by focusing on patient-centered policies and effective communication between organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"No more falling through the cracks": A qualitative study to inform measurement of integration of care of HIV and opioid use disorder. Oldfield, BJ., Muñoz, N., Boshnack, N., et al.[2023]

Despite the availability of effective FDA-approved medications for opioid use disorder (OUD), such as methadone and buprenorphine, most individuals with OUD do not receive these treatments, highlighting a significant treatment gap.

The proposed Cascade of Care framework aims to enhance the treatment of OUD by integrating prevention and treatment strategies, which has garnered interest from major health agencies and could improve outcomes by identifying key interventions and quality indicators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Cascade of Care for responding to the opioid epidemic. Williams, AR., Nunes, EV., Bisaga, A., et al.[2020]

In a study of 147 patients on high-dose opioid therapy, 34% reduced their opioid dosage after implementing the Opioid Safety Initiative, with the median daily dose decreasing from 315 mg to 278 mg.

There was a notable improvement in adherence to safety policies, including an increase in informed consent completion from 31% to 48% and biannual urine drug screenings from 44% to 61%, indicating enhanced monitoring practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of multidisciplinary chart reviews on opioid dose reduction and monitoring practices. Rivich, J., McCauliff, J., Schroeder, A.[2019]

A study of 1244 opioid-dependent individuals found that those who stopped naltrexone treatment experienced significantly higher overdose rates (39 overdoses per 100 person-years) compared to those who left agonist treatments, indicating a critical risk period immediately after stopping naltrexone.

Overall, individuals who left any pharmacotherapy for opioid dependence had much higher rates of serious adverse events and deaths (six per 100 person-years) compared to when they were in treatment, highlighting the need for ongoing support and risk education after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). Digiusto, E., Shakeshaft, A., Ritter, A., et al.[2022]

Multidisciplinary care models that integrate treatment for opioid use disorder (OUD), hepatitis C (HCV), and HIV are essential for preventing the spread of these conditions, with 17 different models identified across various care settings.

Key components of effective care models include medication-assisted treatment for OUD, treatment for HIV and HCV, HIV pre-exposure prophylaxis, and behavioral health services, highlighting the importance of comprehensive approaches in managing these interconnected health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Models of Care for Individuals with Opioid Use Disorder: How Do We Prevent HIV and HCV? Rich, KM., Bia, J., Altice, FL., et al.[2019]

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sciencedirect.com

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