Integrated care for hospitalized patients with opioid and stimulant use disorders and infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a two-group randomized controlled trial conducted at five hospitals across the U.S. It aims to evaluate the effectiveness of an Integrated Infectious Diseases and Substance Use Disorder outpatient clinic compared to standard treatment in reducing infection-related readmissions and improving health outcomes for patients hospitalized with infections due to injecting opioids or stimulants. Participants will be randomly assigned to either the integrated care model or treatment as usual and will be followed for 12 months post-discharge. The study also assesses cost-effectiveness and implementation outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Elana Rosenthal, MD — University of Maryland, Baltimore
• Study coordinator: Rachel Silk
• Email: rsilk@ihv.umaryland.edu
• Phone: 301-326-7652

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CBD for Opioid Dependence and Pain on Buprenorphine

  This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.

  Recruiting Early Phase 1 Yale University · West Haven, Connecticut · NCT07886606

• Cebranopadol for opioid withdrawal in adults with chronic pain

  This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.

  Recruiting at 2 sites Phase 2 Adneuris Therapeutics, Inc. · North Canton, Ohio and 1 other locations · NCT07874620

• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

  This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.

  Recruiting Duke University · Durham, North Carolina · NCT07810322

• CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand

  This study tests CB1 receptor availability in people with opioid use disorder starting opioid agonist therapy and compares them with healthy adults.

  Recruiting Phase 1 Yale University · New Haven, Connecticut · NCT07800520

• STORC: Training a support person plus patient navigation after birth

  We’re testing whether training a designated support person and using patient navigation after delivery helps people with opioid use disorder build recovery resources and stay in treatment.

  Recruiting Friends Research Institute, Inc. · Philadelphia, Pennsylvania · NCT07787039

• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

  A digital platform run by peer recovery supporters will be tested to help adults with opioid use disorder who are on buprenorphine or methadone stay in treatment and improve outcomes.

  Recruiting Rhode Island Hospital · Providence, Rhode Island · NCT07778394

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.