Continuum of Care for Opioid Use Disorder

(CHOICE-STAR Trial)

Recruiting at 3 trial locations

Overseen By Rachel Silk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Elana Rosenthal

Disqualifiers: Non-injection infection, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

608 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a three-group randomized controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of two interventions (1) Integrated infectious diseases and Medication for Opioid or Stimulant Use Disorder outpatient clinic (IC) and (2) NavSTAR Intervention (NS) compared to treatment as usual aimed at reducing infection related readmissions and improving health outcomes in people hospitalized with an infection related to injecting opioids or stimulants.

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 data supports the effectiveness of the treatment Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic for opioid use disorder?

Research shows that integrating care for substance use disorder and infectious diseases can improve outcomes for both conditions. Strategies that combine opioid use disorder treatment with infectious disease care, like using medications such as buprenorphine, methadone, and naltrexone, help reduce unplanned discharges and ensure patients complete their treatment plans. ^{1 2 3 4 5}

Is the Continuum of Care for Opioid Use Disorder treatment safe for humans?

The treatment involves FDA-approved medications like methadone, buprenorphine, and extended-release naltrexone, which have been shown to reduce drug use and overdose events, indicating they are generally safe for humans. ^{3 6 7 8 9}

What makes the NavSTAR-CHOICE treatment unique for opioid use disorder?

The NavSTAR-CHOICE treatment is unique because it integrates care for opioid use disorder with infectious disease management, providing a comprehensive approach that addresses both substance use and related health issues like HIV and hepatitis C in a single clinic setting. This integrated model, which includes peer support, aims to improve patient outcomes by coordinating care across different health needs. ^{2 5 10 11 12}

Research Team

Elana Rosenthal, MD

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

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 18 years old or older.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: NavSTAR-CHOICE (NS) Experimental Treatment 1 Intervention

The NavSTAR (NS) arm will consist of targeted support delivered by a Patient Navigation team (see Navigation Dyad, below) to enhance participants' linkage with outpatient SUD treatment and recommended medical care for infections and other presenting illnesses. The Navigation Dyad will work in concert with existing resources in the hospital system and broader community to ensure continuity of care (initial linkage and subsequent retention) during the 6-month period after hospital discharge when patients are at elevated risk of disengaging from care, inpatient readmission, and other adverse outcomes.

Group II: Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) Experimental Treatment 1 Intervention

The Integrated ID/SUD Clinic will provide facilitated linkage to a clinic providing medical treatment aimed at treating SUD, resolving the sentinel infection, treating existing ID complications of OUD/stimulants (HIV, HCV, wounds) and preventing subsequent infections by providing accessible care for infectious diseases and MOUD treatment that is integrated into a single appointment and co-located at a single site (either in person or via telemedicine) for a minimum of monthly appointments over a 6 month time period. A feature of the IC will be weekly care coordination meetings between the ID and SUD providers. The dual goals of the IC intervention are to 1) to facilitate accessibility to ID and OUD care and 2) to ensure care coordination between outpatient ID and SUD providers.

Group III: Treatment As Usual Active Control 1 Intervention

Will receive treatment for infection and opioid or stimulant use disorder per the usual care at each hospital

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:

• Opioid Use Disorder
• Infectious Complications from Drug Use

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+

Findings from Research

The implementation of a hospital-based protocol (IVAT) significantly increased the use of medications for opioid use disorder (MOUD) among patients with infectious complications, rising from 29% to 37% after the protocol was introduced.

Despite the increase in MOUD uptake, the overall usage remained below 50%, indicating that there are still barriers to accessing these treatments even with a structured intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated Hospital Protocol for Persons With Injection-Related Infections May Increase Medications for Opioid Use Disorder Use but Challenges Remain. Eaton, EF., Lee, RA., Westfall, AO., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Integrating evidence-based management of opioid use disorder (OUD) with patient-centered care for hospitalized patients with injection-related infections can significantly improve treatment outcomes.

Implementing strategies such as screening for OUD, initiating FDA-approved medications, and linking ID and OUD treatment post-discharge can reduce unplanned discharges and enhance adherence to antimicrobial regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Antibiotics: A Practical Guide for the Infectious Disease Physician to Treat Opioid Use Disorder in the Setting of Associated Infectious Diseases. Seval, N., Eaton, E., Springer, SA.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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]

The mobile addiction service, Road to Care, successfully provided holistic addiction care to 1,121 individuals over two years, addressing barriers to treatment access for opioid use disorder, particularly in underserved communities.

The program prescribed buprenorphine/naloxone to 330 patients and distributed nearly 250 naloxone kits, demonstrating its effectiveness in overdose prevention and facilitating further engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile addiction service for community-based overdose prevention. Pepin, MD., Joseph, JK., Chapman, BP., 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]

The pilot study involving 21 pregnant women with opioid dependence showed that a patient navigation (PN) intervention significantly improved abstinence from illicit opioids and reduced depression, indicating its potential effectiveness in this population.

Participants also demonstrated increased engagement with substance use treatment services and achieved adequate prenatal care, suggesting that the PN model could enhance overall health outcomes for pregnant women with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. Cochran, GT., Hruschak, V., Abdullah, W., et al.[2023]

Patient navigation (PN) significantly improved treatment adherence and engagement in opioid use disorder (OUD) among pregnant individuals, with better outcomes in medication use and substance use disorder treatment attendance compared to usual care (UC).

The pilot study, involving 102 pregnant participants, demonstrated that those receiving PN had fewer reported overdoses at 2 and 6 months postpartum, suggesting that PN may enhance safety and effectiveness in managing OUD during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. Cochran, G., Smid, MC., Krans, EE., et al.[2023]

Integrating behavioral health staff into primary care teams is crucial for effectively coordinating substance use disorder (SUD) services, as it helps facilitate important transitions in patient care.

The study identified operational practices from community health centers that successfully coordinate SUD services, but ongoing coordination remains a challenge, highlighting the need for further research to improve health and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing care for patients with substance abuse disorders at community health centers. Gurewich, D., Prottas, J., Sirkin, JT.[2013]

There are major gaps in how people who use illicit substances are identified and engaged in care, similar to challenges seen in HIV care models.

Implementing a care and prevention continuum for substance use disorders could improve patient outcomes and program effectiveness at various levels, drawing on successful strategies from other health fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations for the Development of a Substance-Related Care and Prevention Continuum Model. Perlman, DC., Jordan, AE.[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]

References

1. United States pubmed.ncbi.nlm.nih.gov

An Integrated Hospital Protocol for Persons With Injection-Related Infections May Increase Medications for Opioid Use Disorder Use but Challenges Remain. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Implementing a peer-supported, integrated strategy for substance use disorder care in an outpatient infectious disease clinic is associated with improved patient outcomes. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Beyond Antibiotics: A Practical Guide for the Infectious Disease Physician to Treat Opioid Use Disorder in the Setting of Associated Infectious Diseases. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Integrated outpatient treatment of opioid use disorder and injection-related infections: A description of a new care model. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Integrated Models of Care for Individuals with Opioid Use Disorder: How Do We Prevent HIV and HCV? [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A mobile addiction service for community-based overdose prevention. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Development of a Cascade of Care for responding to the opioid epidemic. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Managing care for patients with substance abuse disorders at community health centers. [2013]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Considerations for the Development of a Substance-Related Care and Prevention Continuum Model. [2023]

12. United States 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. [2022]