Opioid Use DisorderNCT05300581
Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids
A study testing OPAT for PWID in people with Opioid Use Disorder, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Patients with a history of injection drug use are historically excluded from home outpatient parenteral antibiotic therapy programs. Recent small pilot programs have demonstrated that these patients may be safely included in home OPAT programs when they are provided with medications for opioid use disorder such as… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- OPAT for PWID
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2022to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking males and females
- 18-100 years of age
- Being considered for discharge from Barnes-Jewish Hospital on OPAT* (PICC/Midline only) for a serious injection related infection including; endocarditis, osteomyelitis, discitis, septic arthritis, epidural abscess, or S. aureus bacteremia. *Note that outside of this protocol patients with a history of substance use disorder are considered for discharge on OPAT to skilled nursing facilities or other health-care locations such as BJH extended care. Patients being considered for discharge on OPAT to any of these locations are eligible for inclusion.
- History of injection opioid use within the last 1 year
- Evaluated by the joint toxicology/psychiatry addiction medicine consult service during the current inpatient admission
- Started or maintained on medications for opioid use disorder (MOUD) of either methadone, buprenorphine or buprenorphine-naloxone during admission to Barnes-Jewish Hospital
Show all 10Show fewer
- Have a scheduled follow-up for continuation of medications for opioid use disorder in place prior to discharge. For patients on methadone this should include a scheduled appointment at a methadone clinic, or for patients on buprenorphine this can include a plan for ongoing buprenorphine/ buprenorphine-naloxone based therapy at the Washington University Infectious Diseases Clinic.
- Have met with a health coach or a member of the Bridge To Health team during their inpatient hospitalization and agree to ongoing supportive counseling after discharge.
- Be willing and able to attend in-person clinic visits within 60 days post-discharge at the Washington University Infectious Diseases Clinic.
- Have a working phone number with active voicemail, running water and electricity.
Who cannot join
- Prisoner status
- Unable to provide own informed consent
- Current homelessness
- Other house-hold members reported as having active untreated substance use disorders
- Unable to attend outpatient appointments. This may include patients who are from rural areas where transportation vouchers may not provide sufficient means of making it to follow-up appointments, or other disability that would preclude transportation (paralysis, broken limbs) where the patient is unable to provide specific details as to how they would arrive at clinic appointments.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with a history of injection drug use are historically excluded from home outpatient parenteral antibiotic therapy programs. Recent small pilot programs have demonstrated that these patients may be safely included in home OPAT programs when they are provided with medications for opioid use disorder such as suboxone or methadone. However nothing is known about the effect of additional social support services including case management and health coach navigation on the feasibility and acceptibility of home OPAT programs for persons who inject drugs. This observational study will provide pilot data on the feasibility of such a program in anticipation of a larger scale trial.
- Conditions
- Opioid Use Disorder
- Being tested
- OPAT for PWID
- 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.
OPAT for PWIDOther
Observational: Patients with a history of injection opioid use will receive home OPAT while also receiving substance use disorder care including medications for opioid use disorder and multidisciplinary health coach and case management support.
| Study group | Role | What they receive |
|---|---|---|
| Observational Arm | Other | Patients with a history of injection opioid use will receive home OPAT while also receiving substance use disorder care including medications for opioid use disorder and multidisciplinary health coach and case management support. Receives: Other: OPAT for PWID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of parenteral antibiotic therapy
Participants will be asked to self-report compliance to the recommended IV antibiotic therapy during a telephone survey performed at completion of antibiotic therapy.
Measured: 6 weeks patient participation
Illicit drug use
Participants will have urine drug screens performed at clinic follow-up visit while on OPAT.
Measured: 6 weeks patient participation
Secondary outcomes (4)
Survey Completion
Measured: 3 month chart review
90-day microbiologic failure
Measured: 3 month chart review
90-day Overdose
Measured: 3 month chart review
Sample Size Estimation for Future Study
Measured: One year post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start16 Mar 2022
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Marks, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300581
- Sponsor's protocol ID
- 202110063
- Status last verified
- Dec 2025
- First submitted
- 18 Mar 2022
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids
- ClinicalTrials.gov ID
- NCT05300581
- Acronym / sponsor ID
- 202110063
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 29 Mar 2022 (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.
Patients with a history of injection drug use are historically excluded from home outpatient parenteral antibiotic therapy programs. Recent small pilot programs have demonstrated that these patients may be safely included in home OPAT programs when they are provided with medications for opioid use disorder such as suboxone or methadone. However nothing is known about the effect of additional social support services including case management and health coach navigation on the feasibility and acceptibility of home OPAT programs for persons who inject drugs. This observational study will provide pilot data on the feasibility of such a program in anticipation of a larger scale trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Arm | Other | Other: OPAT for PWIDPatients with a history of injection opioid use will receive home OPAT while also receiving substance use disorder care including medications for opioid use disorder and multidisciplinary health coach and case management support. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- English speaking males and females
- 18-100 years of age
- Being considered for discharge from Barnes-Jewish Hospital on OPAT* (PICC/Midline only) for a serious injection related infection including; endocarditis, osteomyelitis, discitis, septic arthritis, epidural abscess, or S. aureus bacteremia. *Note that outside of this protocol patients with a history of substance use disorder are considered for discharge on OPAT to skilled nursing facilities or other health-care locations such as BJH extended care. Patients being considered for discharge on OPAT to any of these locations are eligible for inclusion.
- History of injection opioid use within the last 1 year
- Evaluated by the joint toxicology/psychiatry addiction medicine consult service during the current inpatient admission
Key exclusion criteria (5 listed)
- Prisoner status
- Unable to provide own informed consent
- Current homelessness
- Other house-hold members reported as having active untreated substance use disorders
- Unable to attend outpatient appointments. This may include patients who are from rural areas where transportation vouchers may not provide sufficient means of making it to follow-up appointments, or other disability that would preclude transportation (paralysis, broken limbs) where the patient is unable to provide specific details as to how they would arrive at clinic appointments.
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 |
|---|---|---|
| OPAT for PWIDObservational: Patients with a history of injection opioid use will receive home OPAT while also receiving substance use disorder care including medications for opioid use disorder and multidisciplinary health coach and case management support. | Other | Observational Arm |
Primary outcome
Completion of parenteral antibiotic therapy
Time frame: 6 weeks patient participation
Participants will be asked to self-report compliance to the recommended IV antibiotic therapy during a telephone survey performed at completion of antibiotic therapy.
Illicit drug use
Time frame: 6 weeks patient participation
Participants will have urine drug screens performed at clinic follow-up visit while on OPAT.
4 secondary outcomes
Survey Completion
Time frame: 3 month chart review
90-day microbiologic failure
Time frame: 3 month chart review
90-day Overdose
Time frame: 3 month chart review
Sample Size Estimation for Future Study
Time frame: One year post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- 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. This study is not recruiting at the moment.
Laura Marks, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPAT for PWID in people with Opioid Use Disorder, run by Washington University School of Medicine at 1 site 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of parenteral antibiotic therapy (time frame: 6 weeks patient participation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.