Opioid Use DisorderCHOICE-STARNCT06513156
Continuum of Care in Hospitalized Patients With Opioid/Stimulant Use Disorder and Infectious Complications From Drug Use
A study testing Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) in people with Opioid Use Disorder and Injection Related Infections, run by Elana Rosenthal at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Injection Related Infections, Stimulant Use Disorder
- What is being tested?
- Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Oct 2024to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 27Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Joseph Carpenter, MD, joseph.edward.carpenter@emory.edu
Joseph Carpenter, MD
- Recruiting
University of Maryland Baltimore
Baltimore, Maryland, 21201
Rachel Silk, 3013267652, rsilk@ihv.umaryland.edu
Edward Traver, MD
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Rebecca Reece, MD, rreece@hsc.wvu.edu
Rebecca Reece, MD
- Recruiting
George Washington University
Washington D.C., District of Columbia, 20052
Jill Catalanotti, MD, jcatalanotti@mfa.gwu.edu
Jill Catalanotti, MD
About this study
Official title: Continuum of Care in Hospitalized Patients With Opioid or Stimulant Use Disorder and Infectious Complications of Drug Use - Substance Use/ID Integrated Clinic vs. TAU to Prevent Infection Related Readmission
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.
Read the detailed description
This is a phase III two arm randomized controlled trial to determine the impact and Integrated infectious diseases (ID) and Substance Use Disorder outpatient clinic (IC) compared to treatment as usual on infection related rehospitalization in individuals hospitalized with infections due to injecting opioids or Stimulants, in the 6 month time period after discharge. This study includes both cost effectiveness and implementation outcomes.
(1) IC will provide facilitated linkage to a clinic providing medical treatment aimed at treating substance use disorder (SUD), resolving the index infection, treating existing ID complications of OUD (HIV, HCV, wounds) and preventing subsequent infections by providing accessible care for infectious diseases and medication for OUD (MOUD) treatment that is integrated into a single appointment and co-located at a single site (either in person or via telemedicine) for a minimum of monthly appointments over a 6 month time period. A feature of the IC will be weekly care coordination meetings between the ID and MOUD providers.
The study will recruit patients during hospitalization for an infection due to injecting opioids or stimulants at four hospital systems (five hospitals) and randomly assign approximately 304 inpatients in 1:1 ratio to IC vs TAU.
Participants will be followed for 12 months.
- Being tested
- Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)
- Keywords
- Delivery of Health Care, Integrated, Opioid use disorder, Serious Injection Related Infections, Stimulant Use Disorder
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)Behavioural
Integrated medication for opioid/stimulant use disorder and infectious disease care provided into single appointment either in person or via telemedicine with a minimum of monthly appointments for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | No intervention | Will receive treatment for infection and opioid or stimulant use disorder per the usual care at each hospital |
| Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) | Experimental | The Integrated ID/SUD Clinic will provide facilitated linkage to a clinic providing medical treatment aimed at treating SUD, resolving the sentinel infection, treating existing ID complications of OUD/stimulants (HIV, HCV, wounds) and preventing subsequent infections by providing accessible care for infectious diseases and MOUD treatment that is integrated into a single appointment and co-located at a single site (either in person or via telemedicine) for a minimum of monthly appointments over a 6 month time period. A feature of the IC will be weekly care coordination meetings between the ID and SUD providers. The dual goals of the IC intervention are to 1) to facilitate accessibility to ID and OUD care and 2) to ensure care coordination between outpatient ID and SUD providers. Receives: Behavioral: Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Rehospitalization
New hospitalization due to infection following discharge for index hospitalization
Measured: 6 months after discharge for index hospitalization
Secondary outcomes (14)
Time to first infection related readmission
Time to first infection related readmission
Measured: 12 months after discharge for index hospitalization
Reason for infection related readmission
Reason for infection related readmission (persistent index infection, new IDU associated infection, other infection)
Measured: 12 months after discharge for index hospitalization
Hospital services utilization
ED visits (Binary, count, time to first ED visit, cause) and Readmission, all cause (binary, count, time to first readmission, cause)
Measured: 12 months after discharge for index hospitalization
Mortality
Death (Binary, time to death, cause of death)
Measured: 12 months after discharge for index hospitalization
Index infection
Completion of antibiotics (binary, reason for incomplete antibiotics); Resolution of index infection (binary) Skilled Nursing Facility (SNF) Admitted to SNF (binary) Discharge type from SNF (planned, PDD, dead, transfer)
Measured: 3 months after discharge for index hospitalization
Other Infections
HCV Active HCV (binary) Clinical evaluation (binary) DAA prescribed (binary) DAA initiated (binary) SVR achieved (binary) HIV Diagnosis status (binary) HIV VL undetectable (binary) ART Taking (binary) Type (pills vs injections) Adherence (# missed doses in last 30 days) PrEP Eligible (CDC Criteria, binary, indication) Offered by healthcare provider (binary) Taking (binary) Type (pills vs injections) Adherence (# missed doses in last 30 days)
Measured: 12 months after discharge for index hospitalization
Skin and soft tissue wounds
Present (binary) Number (count) Per wound Size Location on body Duration (continuous)
Measured: 12 months after discharge for index hospitalization
New infections not requiring hospitalization
- Present (binary)
- Number (count)
Measured: 12 months after discharge for index hospitalization
Outpatient linkage and retention
- Infectious Diseases Clinic (binary, time to linkage, count)
- Medication for OUD Treatment (binary, time to linkage, count)
- Non-medication based OUD Treatment (binary, time to linkage, count)
Measured: 12 months after discharge for index hospitalization
Medication for Opioid Use (MOUD)
- On treatment (binary)
- MOUD type
- MOUD Dose
- MOUD Dose adequacy
- MOUD Source of medication
- MOUD Location type
- MOUD Co-location with other services
- Reasons for no MOUD (descriptive)
Measured: 12 months after discharge for index hospitalization
Medication for stimulant use (MStUD)
- On treatment (binary) MStUD type
- MStUD Dose
- MStUD Dose adequacy
- MStUD Source of medication
- MStUD Location type
- MStUD Co-location with other services
- Reasons for no MStUD (descriptive)
Measured: 12 months after discharge for index hospitalization
Substance Use-Opioid
Ongoing opioid (binary, mode)
- Opioid use frequency
- Mode of opioid use
- Opioid craving
- Other drug use (binary, mode)
- Other drug use frequency
- IDU (binary, frequency, mode (IM, IV, skin, other), location, syringe reuse, ssp engagement).
- Severity (DAST)
- Overdose (binary, count)
- Tobacco use
- UDS (binary - presence of opioids, )
Measured: 12 months after discharge for index hospitalization
Substance Use - Stimulant
Ongoing stimulant use (binary, mode)
- Stimulant use frequency
- Mode of stimulant use
- Cocaine craving
- Methamphetamine craving
- Other drug use (binary, mode)
- Other drug use frequency
- IDU (binary, frequency, mode (IM, IV, skin, other), location, syringe reuse, ssp engagement).
- Severity (DAST)
- Overdose (binary, count)
- Tobacco use
- UDS (binary - presence of cocaine, amphetamines, other)
Measured: 12 months after discharge for index hospitalization
Cost Effectiveness
- ICER for quality adjusted life years (QALYs); opioid-free years (OfYs); and infection-free years (IfYs) gained
Measured: 12 months after discharge for index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Oct 2024
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elana Rosenthal
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, George Washington University, West Virginia University, Weill Medical College of Cornell University, Friends Research Institute, Inc.
- Responsible party
- Sponsor-investigator, Elana Rosenthal, University of Maryland, Baltimore
- Investigators
- Elana Rosenthal, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513156
- Sponsor's protocol ID
- HP-00111318
- Acronym
- CHOICE-STAR
- Status last verified
- Oct 2025
- First submitted
- 8 Jul 2024
- Last updated
- 31 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenthal ES, Lavoie MC, Traver E, Gryczynski J, Nordeck C, Carpenter JE, Reece R, Kuo I, Catalanotti JS, Steck AR, Cooper G, Fujita AW, Murphy SM, Mansfield ME, Ramadhani HO, Silk R, Masur H, Kattakuzhy S. Continuum of care in hospitalized patients with opioid or stimulant use disorder and infectious complications of drug use-substance use/infectious disease integrated clinic compared to treatment as usual to prevent infection-related readmission (CHOICE-STAR): a study protocol for an effectiveness-implementation randomized controlled trial. Trials. 2026 Mar 4;27(1):291. doi: 10.1186/s13063-026-09550-5.
PubMed 41776656
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuum of Care in Hospitalized Patients With Opioid or Stimulant Use Disorder and Infectious Complications of Drug Use - Substance Use/ID Integrated Clinic vs. TAU to Prevent Infection Related Readmission
- ClinicalTrials.gov ID
- NCT06513156
- Acronym / sponsor ID
- CHOICE-STAR / HP-00111318
- Keywords
- Delivery of Health Care, Integrated, Opioid use disorder, Serious Injection Related Infections, Stimulant Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Elana RosenthalUniversity, hospital or other
- Collaborators
- Emory University, George Washington University, West Virginia University, Weill Medical College of Cornell University, Friends Research Institute, Inc.
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase III two arm randomized controlled trial to determine the impact and Integrated infectious diseases (ID) and Substance Use Disorder outpatient clinic (IC) compared to treatment as usual on infection related rehospitalization in individuals hospitalized with infections due to injecting opioids or Stimulants, in the 6 month time period after discharge. This study includes both cost effectiveness and implementation outcomes.
(1) IC will provide facilitated linkage to a clinic providing medical treatment aimed at treating substance use disorder (SUD), resolving the index infection, treating existing ID complications of OUD (HIV, HCV, wounds) and preventing subsequent infections by providing accessible care for infectious diseases and medication for OUD (MOUD) treatment that is integrated into a single appointment and co-located at a single site (either in person or via telemedicine) for a minimum of monthly appointments over a 6 month time period. A feature of the IC will be weekly care coordination meetings between the ID and MOUD providers.
The study will recruit patients during hospitalization for an infection due to injecting opioids or stimulants at four hospital systems (five hospitals) and randomly assign approximately 304 inpatients in 1:1 ratio to IC vs TAU.
Participants will be followed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | No intervention | –Will receive treatment for infection and opioid or stimulant use disorder per the usual care at each hospital |
| Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) | Experimental | Behavioral: Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)The Integrated ID/SUD Clinic will provide facilitated linkage to a clinic providing medical treatment aimed at treating SUD, resolving the sentinel infection, treating existing ID complications of OUD/stimulants (HIV, HCV, wounds) and preventing subsequent infections by providing accessible care for infectious diseases and MOUD treatment that is integrated into a single appointment and co-located at a single site (either in person or via telemedicine) for a minimum of monthly appointments over a 6 month time period. A feature of the IC will be weekly care coordination meetings between the ID and SUD providers. The dual goals of the IC intervention are to 1) to facilitate accessibility to ID and OUD care and 2) to ensure care coordination between outpatient ID and SUD providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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.
- Non-vertebral osteomyelitis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)Integrated medication for opioid/stimulant use disorder and infectious disease care provided into single appointment either in person or via telemedicine with a minimum of monthly appointments for 6 months. | Behavioural | Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) |
Primary outcome
Infection Rehospitalization
Time frame: 6 months after discharge for index hospitalization
New hospitalization due to infection following discharge for index hospitalization
14 secondary outcomes
Time to first infection related readmission
Time frame: 12 months after discharge for index hospitalization
Reason for infection related readmission
Time frame: 12 months after discharge for index hospitalization
Hospital services utilization
Time frame: 12 months after discharge for index hospitalization
Mortality
Time frame: 12 months after discharge for index hospitalization
Index infection
Time frame: 3 months after discharge for index hospitalization
Other Infections
Time frame: 12 months after discharge for index hospitalization
Skin and soft tissue wounds
Time frame: 12 months after discharge for index hospitalization
New infections not requiring hospitalization
Time frame: 12 months after discharge for index hospitalization
Outpatient linkage and retention
Time frame: 12 months after discharge for index hospitalization
Medication for Opioid Use (MOUD)
Time frame: 12 months after discharge for index hospitalization
Medication for stimulant use (MStUD)
Time frame: 12 months after discharge for index hospitalization
Substance Use-Opioid
Time frame: 12 months after discharge for index hospitalization
Substance Use - Stimulant
Time frame: 12 months after discharge for index hospitalization
Cost Effectiveness
Time frame: 12 months after discharge for index hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Derived from this study: PubMed 41776656Rosenthal ES, Lavoie MC, Traver E, Gryczynski J, Nordeck C, Carpenter JE, Reece R, Kuo I, Catalanotti JS, Steck AR, Cooper G, Fujita AW, Murphy SM, Mansfield ME, Ramadhani HO, Silk R, Masur H, Kattakuzhy S. Continuum of care in hospitalized patients with opioid or stimulant use disorder and infectious complications of drug use-substance use/infectious disease integrated clinic compared to treatment as usual to prevent infection-related readmission (CHOICE-STAR): a study protocol for an effectiveness-implementation randomized controlled trial. Trials. 2026 Mar 4;27(1):291. doi: 10.1186/s13063-026-09550-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elana Rosenthal, MD principal investigator
University of Maryland, Baltimore
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) in people with Opioid Use Disorder and Injection Related Infections, run by Elana Rosenthal at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Silk (301-326-7652, rsilk@ihv.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection Rehospitalization (time frame: 6 months after discharge for index hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06513156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.