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

Recruiting now · Not applicable

Conditions studied: Opioid Use Disorder, Injection Related Infections, Stimulant Use Disorder

In brief

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 facts

Study ID

NCT06513156

Run by

Elana Rosenthal

People needed

304

Starts

2024-10-01

Expected to finish

2027-07-30

Last updated by the study team

2025-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

You may not qualify if…

• 1. 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

Where it is running

• George Washington University — Washington D.C., District of Columbia, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• University of Maryland Baltimore — Baltimore, Maryland, United States (enrolling)
• West Virginia University — Morgantown, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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