NCT06513156 · Elana Rosenthal
Continuum of Care in Hospitalized Patients With Opioid/Stimulant Use Disorder and Infectious Complications From Drug Use
(CHOICE-STAR)
What this study is about
This is a two-group randomly assigned 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Where
- Washington D.C., District of Columbia
- Atlanta, Georgia
- Baltimore, Maryland
- Morgantown, West Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 31, 2025 · Source of record for eligibility and locations