Continuum of Care in Hospitalized Patients With Opioid/Stimulant Use Disorder and Infectious Complications From Drug Use

NCT06513156 | Recruiting DMC

• 1 other identifier: HP-00111318
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 4

Brief Summary

This is a two-group randomized controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of an Integrated infectious diseases/Substance Use Disorder outpatient clinic (IC) 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.

Conditions

Opioid Use Disorder; Injection Related Infections; Stimulant Use Disorder

Keywords

Delivery of Health Care, Integrated; Opioid use disorder; Serious Injection Related Infections; Stimulant Use Disorder

Outcome Measures

Primary Outcomes (1)

• Infection Rehospitalization

  New hospitalization due to infection following discharge for index hospitalization

  6 months after discharge for index hospitalization

Secondary Outcomes (14)

• Time to first infection related readmission

  12 months after discharge for index hospitalization

• Reason for infection related readmission

  12 months after discharge for index hospitalization

• Hospital services utilization

  12 months after discharge for index hospitalization

• Mortality

  12 months after discharge for index hospitalization

• Index infection

  3 months after discharge for index hospitalization

Study Arms (2)

Treatment As Usual

NO INTERVENTION

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

Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)

EXPERIMENTAL

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.

Behavioral: Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)

Interventions

Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) BEHAVIORAL

Integrated medication for opioid/stimulant use disorder and infectious disease care provided into single appointment either in person or via telemedicine with a minimum of monthly appointments for 6 months.

Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine)
• Injection opioid or stimulant use in past 90 days - per patient self-report
• Active suspected or confirmed qualifying infection (see list) at time of admission.
• Qualifying infections:
• Non-vertebral osteomyelitis
• Vertebral osteomyelitis or discitis
• Epidural, subdural, or extradural abscess
• Intracranial or intraspinal abscess
• Native joint septic arthritis
• Prosthetic joint septic arthritis
• Blood stream infection (bacterial or fungal)
• Native valve Endocarditis
• Prosthetic valve endocarditis
• Cardiac Implantable electronic device infection

You may not qualify if:

• \. Infection due to a cause other than injection drug use, per determination of a site PI.
• \. Inability to provide consent due to circumstance (e.g., sedated, intubated), language, or cognitive impairment.
• \. Unwilling to provide informed consent 4. Unable to receive potential interventions due to geography 5. On comfort measures or planned for discharge to hospice care 6. Incarcerated at the time of hospitalization 7. Other criteria at the discretion of the site investigator

Sponsors & Collaborators

• Elana Rosenthal: lead
• Emory University: collaborator
• George Washington University: collaborator
• West Virginia University: collaborator
• Weill Medical College of Cornell University: collaborator
• Friends Research Institute, Inc.: collaborator

Study Sites (4)

George Washington University

Washington D.C., District of Columbia, 20052, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Elana Rosenthal, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Silk

CONTACT

301-326-7652; rsilk@ihv.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 22, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)