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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Elana Rosenthal
Study ID
NCT06513156
Status
Recruiting
Apply to this trial

Conditions

  • Injection Related Infections
  • Opioid Use Disorder
  • Stimulant Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Oct 2025
Primary completion
Jul 30, 2026
Completion
Jul 30, 2027

Study Design

Enrollment
304 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
George Washington UniversityWashington D.C.District of Columbia20052
Jill Catalanotti, MD
[email protected]
Jill Catalanotti, MD (PRINCIPAL_INVESTIGATOR)
Irene Kuo, MD (SUB_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Joseph Carpenter, MD
[email protected]
Joseph Carpenter, MD (PRINCIPAL_INVESTIGATOR)
Alina Steck, MD (SUB_INVESTIGATOR)
University of Maryland BaltimoreBaltimoreMaryland21201
Rachel Silk
[email protected]
3013267652
Edward Traver, MD (SUB_INVESTIGATOR)
Elana Rosenthal, MD (PRINCIPAL_INVESTIGATOR)
Sarah Kattakuzhy, MD (SUB_INVESTIGATOR)
West Virginia UniversityMorgantownWest Virginia26506
Rebecca Reece, MD
[email protected]
Rebecca Reece, MD (PRINCIPAL_INVESTIGATOR)
Clinton Cooper, MD (SUB_INVESTIGATOR)

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By research site
George Washington University· Washington D.C., DCEmory University· Atlanta, GAUniversity of Maryland Baltimore· Baltimore, MDWest Virginia University· Morgantown, WV

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