304 Participants Needed

Continuum of Care for Opioid Use Disorder

(CHOICE-STAR Trial)

Recruiting at 4 trial locations
RS
Overseen ByRachel Silk
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Elana Rosenthal
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special clinic, the Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic, can improve health outcomes for individuals hospitalized with infections from injecting opioids or stimulants. It compares this approach to the usual hospital treatment. The trial seeks participants who have injected opioids or stimulants in the last 90 days and are currently hospitalized with specific infections, such as bone infections or abscesses. Participants will receive either integrated clinic care or standard hospital care to assess which is more effective. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance treatment for future patients.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic and NavSTAR-CHOICE are safe?

Studies have shown that combining care for infectious diseases and substance use in one clinic can improve health for people who inject drugs. This approach initiates treatment for opioid addiction and ensures necessary antibiotic use. These outcomes indicate safety and effectiveness.

Research indicates that connecting people with opioid addiction to proven treatments reduces illegal drug use and the risk of overdose. This suggests that the care provided in these clinics is both safe and beneficial.

Overall, the integrated clinic model aims to make healthcare more accessible and organized. By offering treatment for infections and substance use in one location, it has been linked to better healthcare use and outcomes for patients.12345

Why are researchers excited about this trial?

Researchers are excited about the Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) because it offers a holistic approach to treating opioid use disorder (OUD) that stands out from traditional treatment methods. Unlike standard care, which often separates the treatment of infections and substance use disorders, the IC combines these services into a single, co-located appointment. This integrated model not only aims to treat OUD and related infections like HIV and HCV but also focuses on preventing future infections through accessible care. Additionally, the clinic's weekly care coordination meetings ensure seamless collaboration between infectious disease and substance use disorder providers, enhancing patient outcomes and accessibility.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

This trial will compare different approaches to treating opioid use disorder and related infections. Research has shown that integrating care for infectious diseases and substance use disorder (SUD), as implemented in the Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) arm of this trial, can significantly improve health outcomes. Studies have found that when healthcare teams provide both services together, individuals use healthcare more effectively, more people start medications for opioid use disorder (MOUD), and more complete their antibiotics for infections from injecting drugs. Evidence strongly supports the success of MOUD, which includes medications like methadone, buprenorphine, and naltrexone, in treating opioid addiction. Furthermore, connecting individuals with opioid addiction to treatment reduces drug use and the risk of overdose. Overall, this combined approach aims to offer accessible and well-coordinated care, which is crucial for improving health in those with drug-related infections.13567

Who Is on the Research Team?

ER

Elana Rosenthal, MD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for hospitalized patients with opioid use disorder who have infections due to drug use, such as abscesses. Participants must meet certain health criteria to join.

Inclusion Criteria

Admitted to study hospital with a primary team that is not Emergency Medicine
Injection opioid use in past 90 days per patient self-report
I am currently admitted with a suspected or confirmed infection.

Exclusion Criteria

Other criteria at the discretion of the site investigator
Incarcerated at the time of hospitalization
I am receiving comfort care or will be moving to hospice.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hospitalization

Participants are hospitalized for an infection due to injecting opioids and randomly assigned to one of the three intervention arms

Varies

Intervention

Participants receive one of the three interventions: Integrated ID/MOUD Clinic, NavSTAR Intervention, or Treatment As Usual, aimed at reducing infection-related readmissions and improving health outcomes

6 months
Monthly appointments (in-person or telemedicine)

Follow-up

Participants are monitored for safety, effectiveness, and various health outcomes after the intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic
  • NavSTAR-CHOICE
Trial Overview The study compares two approaches: an outpatient clinic integrating infectious disease and opioid use disorder treatments (IC), and the NavSTAR Intervention (NS) against usual care in reducing infection-related readmissions.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)Experimental Treatment1 Intervention
Group II: Treatment As UsualActive Control1 Intervention

Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic is already approved in United States for the following indications:

🇺🇸
Approved in United States as Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Elana Rosenthal

Lead Sponsor

Trials
1
Recruited
610+

George Washington University

Collaborator

Trials
263
Recruited
476,000+

Weill Medical College of Cornell University

Collaborator

Trials
1,103
Recruited
1,157,000+

West Virginia University

Collaborator

Trials
192
Recruited
64,700+

Friends Research Institute, Inc.

Collaborator

Trials
60
Recruited
22,500+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

Published Research Related to This Trial

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.
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]
The RESTORE program successfully integrated peer-supported substance use disorder (SUD) care into an outpatient infectious disease (ID) clinic, leading to an eightfold increase in clinicians prescribing buprenorphine from 5% to 39%.
Patients engaged in the program showed significant improvements over six months, including a reduction in illicit opioid use from 52% to 32%, decreased cocaine use, and fewer emergency department visits and hospitalizations, indicating effective outcomes from the integration of SUD care.
Implementing a peer-supported, integrated strategy for substance use disorder care in an outpatient infectious disease clinic is associated with improved patient outcomes.Falade-Nwulia, O., Agee, T., Kelly, SM., et al.[2023]
A novel integrated care model for patients with opioid use disorder (OUD) and severe injection-related infections (SIRI) allows for the combination of addiction treatment and outpatient parenteral antimicrobial therapy (OPAT), which is typically not offered to these patients due to concerns about their drug use.
This pilot study highlights the potential for improved management of OUD and SIRI by providing buprenorphine induction during hospitalization and continuing care in an outpatient setting, suggesting a promising approach to address both addiction and infection treatment simultaneously.
Integrated outpatient treatment of opioid use disorder and injection-related infections: A description of a new care model.Fanucchi, LC., Walsh, SL., Thornton, AC., et al.[2020]

Citations

Integrated Infectious Disease and Substance Use Disorder ...An integrated ID/SUD team was associated with improvements in healthcare utilization, MOUD initiation, and antibiotic completion for PWID with infections.
Project Details - NIH RePORTEREvidence supporting the efficacy of three FDA-approved medications for OUD (MOUD), including methadone, buprenorphine and naltrexone, is well established. MOUD ...
Linking People with Opioid Use Disorder to Medication ...Linking persons with OUD to evidence-based treatment while they are incarcerated or under community supervision reduces illegal drug use, overdose risk, and ...
A Systematic Review and Meta-Analysis of Studies Evaluating ...We determined the impact of medications for opioid use disorder (MOUD) on treatment outcomes of opioid use disorder (OUD)-associated infectious diseases.
Evaluation of a primary care-based Medication for Opioid ...Data collected from July 1, 2022 to December 31, 2022 showed a 6-month retention rate of 85 % (N = 186). Urine drug screens were opioid-negative for 91 % of ...
Continuum of Care in Patients Hospitalized with Infectious ...The research includes a study across all sites to evaluate two interventions: (1) an integrated infectious diseases and medications for opioid ...
The Role of MOUD in Addressing Opioid Use Disorder and ...Examine the connection between OUD and infectious disease. · Discuss increased risk for infections among people with OUD. · Describe the benefits of MOUD and ...
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