NCT06513156 Continuum of Care in Hospitalized Patients With Opioid/Stimulant Use Disorder and Infectious Complications From Drug Use
| NCT ID | NCT06513156 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Elana Rosenthal |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 304 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 304 participants in total. It began in 2024-10-01 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Elana Rosenthal, MD
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT06513156 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06513156 currently recruiting?
Yes, NCT06513156 is actively recruiting participants. Contact the research team at rsilk@ihv.umaryland.edu for enrollment information.
Where is the NCT06513156 trial being conducted?
This trial is being conducted at Washington D.C., United States, Atlanta, United States, Baltimore, United States, Morgantown, United States.
Who is sponsoring the NCT06513156 clinical trial?
NCT06513156 is sponsored by Elana Rosenthal. The principal investigator is Elana Rosenthal, MD at University of Maryland, Baltimore. The trial plans to enroll 304 participants.