Recruiting

Observational Study

Sponsor:

Elana Rosenthal

Code:

NCT06513156

Conditions

Opioid Use Disorder

Injection Related Infections

Stimulant Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)

Study Details

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

Study ID

NCT06513156

Start date

Oct 1, 2024

Status verified date

Oct, 2025

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years
2. Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine)
3. Injection opioid or stimulant use in past 90 days - per patient self-report
4. 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
  • Infectious pseudoaneurysm and aneurysm
  • Infected vascular graft
  • Septic venous thrombosis
  • Skin and Soft tissue infection (cellulitis, skin abscess, necrotizing fasciitis)
  • Infected skin ulcer
  • Orthopedic hardware infection
  • Muscle abscess/myositis
  • Central nervous system infection (bacterial or fungal)
  • Bacterial or fungal ophthalmologic infection
  • Other abscess
  • Pulmonary septic emboli
  • Other acute bacterial or fungal infection deemed appropriate by site study team

Exclusion Criteria:

  • 1\. Infection due to a cause other than injection drug use, per determination of a site PI.

2\. Inability to provide consent due to circumstance (e.g., sedated, intubated), language, or cognitive impairment.

3\. 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

Study Design

Enrollment

304 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Treatment As Usual

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

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

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.

Interventions

Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)

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.

Primary outcome measure

  • Infection Rehospitalization [ Time Frame: 6 months after discharge for index hospitalization ]

Central Contacts and Locations

Central contacts

Rachel Silk

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

Locations

George Washington University

Recruiting

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

Contacts

Jill Catalanotti, MD

jcatalanotti@mfa.gwu.edu

Principal Investigator:

Jill Catalanotti, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Joseph Carpenter, MD

joseph.edward.carpenter@emory.edu

Principal Investigator:

Joseph Carpenter, MD

University of Maryland Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Rachel Silk

3013267652rsilk@ihv.umaryland.edu

Principal Investigator:

Elana Rosenthal, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Rebecca Reece, MD

rreece@hsc.wvu.edu

Principal Investigator:

Rebecca Reece, MD

More Information

Sponsor

Elana Rosenthal

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Elana Rosenthal on 2025-10-31.