Continuum of Care for Opioid Use Disorder
(CHOICE-STAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a special clinic, the Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic, can improve health outcomes for individuals hospitalized with infections from injecting opioids or stimulants. It compares this approach to the usual hospital treatment. The trial seeks participants who have injected opioids or stimulants in the last 90 days and are currently hospitalized with specific infections, such as bone infections or abscesses. Participants will receive either integrated clinic care or standard hospital care to assess which is more effective. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance treatment for future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic and NavSTAR-CHOICE are safe?
Studies have shown that combining care for infectious diseases and substance use in one clinic can improve health for people who inject drugs. This approach initiates treatment for opioid addiction and ensures necessary antibiotic use. These outcomes indicate safety and effectiveness.
Research indicates that connecting people with opioid addiction to proven treatments reduces illegal drug use and the risk of overdose. This suggests that the care provided in these clinics is both safe and beneficial.
Overall, the integrated clinic model aims to make healthcare more accessible and organized. By offering treatment for infections and substance use in one location, it has been linked to better healthcare use and outcomes for patients.12345Why are researchers excited about this trial?
Researchers are excited about the Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) because it offers a holistic approach to treating opioid use disorder (OUD) that stands out from traditional treatment methods. Unlike standard care, which often separates the treatment of infections and substance use disorders, the IC combines these services into a single, co-located appointment. This integrated model not only aims to treat OUD and related infections like HIV and HCV but also focuses on preventing future infections through accessible care. Additionally, the clinic's weekly care coordination meetings ensure seamless collaboration between infectious disease and substance use disorder providers, enhancing patient outcomes and accessibility.
What evidence suggests that this trial's treatments could be effective for opioid use disorder?
This trial will compare different approaches to treating opioid use disorder and related infections. Research has shown that integrating care for infectious diseases and substance use disorder (SUD), as implemented in the Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) arm of this trial, can significantly improve health outcomes. Studies have found that when healthcare teams provide both services together, individuals use healthcare more effectively, more people start medications for opioid use disorder (MOUD), and more complete their antibiotics for infections from injecting drugs. Evidence strongly supports the success of MOUD, which includes medications like methadone, buprenorphine, and naltrexone, in treating opioid addiction. Furthermore, connecting individuals with opioid addiction to treatment reduces drug use and the risk of overdose. Overall, this combined approach aims to offer accessible and well-coordinated care, which is crucial for improving health in those with drug-related infections.13567
Who Is on the Research Team?
Elana Rosenthal, MD
Principal Investigator
University of Maryland, Baltimore
Are You a Good Fit for This Trial?
This trial is for hospitalized patients with opioid use disorder who have infections due to drug use, such as abscesses. Participants must meet certain health criteria to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Hospitalization
Participants are hospitalized for an infection due to injecting opioids and randomly assigned to one of the three intervention arms
Intervention
Participants receive one of the three interventions: Integrated ID/MOUD Clinic, NavSTAR Intervention, or Treatment As Usual, aimed at reducing infection-related readmissions and improving health outcomes
Follow-up
Participants are monitored for safety, effectiveness, and various health outcomes after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic
- NavSTAR-CHOICE
Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic is already approved in United States for the following indications:
- Opioid Use Disorder
- Infectious Complications from Drug Use
Find a Clinic Near You
Who Is Running the Clinical Trial?
Elana Rosenthal
Lead Sponsor
George Washington University
Collaborator
Weill Medical College of Cornell University
Collaborator
West Virginia University
Collaborator
Friends Research Institute, Inc.
Collaborator
Emory University
Collaborator