Drug UsePhase 2BOPATNCT04677114
Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
A Phase 2 study testing Buprenorphine and Outpatient Parenteral Antibiotic Therapy in people with Drug Use and Opioid-use Disorder, run by Laura Fanucchi at 1 site in United States.
Trial summary
This study will assess the efficacy of an integrated outpatient treatment model for persons with opioid use disorder and injection related infections. The investigators hypothesize that outpatient antibiotic treatment coupled with comprehensive treatment for opioid use disorder will demonstrate a safe and effective… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Drug Use, Opioid-use Disorder
- What is being tested?
- Buprenorphine and Outpatient Parenteral Antibiotic Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 6 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have opioid use disorder
- have a severe injection related infection requiring antibiotics
- willing to accept buprenorphine treatment
- anticipated to be discharged home
- require IV antibiotic therapy
Who cannot join
- stroke or cerebral mycotic aneurysms preventing aortic or mitral valve surgery
- fungal valve IE
- requiring in-patient rehabilitation
- current pregnancy
- hypersensitivity or allergy to buprenorphine
- class III or IV heart failure
Show all 12Show fewer
- end-stage liver or renal disease
- any condition that may prevent the volunteer from safely participating in the study
- self-report of desire to inject into the PICC line
- pending legal action that could interfere with study participation
- unsafe or unstable environment precluding safe administration of IV antibiotics
- living more than a 60 minute drive outside of Lexington, KY
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess the efficacy of an integrated outpatient treatment model for persons with opioid use disorder and injection related infections. The investigators hypothesize that outpatient antibiotic treatment coupled with comprehensive treatment for opioid use disorder will demonstrate a safe and effective way to manage patients. Results could improve the current protocols for the treatment of individuals with opioid use disorder and severe infections.
- Conditions
- Drug Use, Opioid-use Disorder
- Being tested
- Buprenorphine and Outpatient Parenteral Antibiotic Therapy, Buprenorphine and standard of care antibiotic treatment
- Keywords
- buprenorphine, outpatient, parenteral, antibiotic, OPAT, injection, infectious endocarditis, injection-related, infection
- Medical subject headings
- Opioid-Related Disorders, Endocarditis, Subacute Bacterial, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine and Outpatient Parenteral Antibiotic TherapyDrug
Also called Suboxone or Sublocade
Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.
Buprenorphine and standard of care antibiotic treatmentDrug
Also called Suboxone or Sublocade
All participants will receive treatment of OUD and the infection per usual clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Parenteral Antibiotic Therapy (OPAT) | Experimental | Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT). Receives: Drug: Buprenorphine and Outpatient Parenteral Antibiotic Therapy |
| Treatment as Usual (TAU) | Active comparator | Patients with OUD and severe, injection-related infections (SIRI) will receive usual care. Receives: Drug: Buprenorphine and standard of care antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illicit Opioid Use
Proportion of urine samples with negative urine drug screen for illicit opioid use
Measured: 12 weeks after hospital discharge
Secondary outcomes (4)
Completion of Recommended IV Antibiotic Therapy
number of patients who completed recommended IV antibiotic therapy
Measured: up to 12 weeks (duration of IV antibiotic course as determined by treating physician)
Abstinence From Illicit Opioid
Self-reported number of days of illicit opioid abstinence
Measured: 12 weeks after hospital discharge
Injection Drug Use
Self-reported number of days of injection use of any drug
Measured: 12 weeks after hospital discharge
Outpatient Treatment Retention
Number of days patients remain in treatment.
Measured: 12 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start16 Mar 2021
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug UseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Fanucchi
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Laura Fanucchi, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677114
- Sponsor's protocol ID
- 60903
- Other IDs
- 1R01DA048892
- Acronym
- BOPAT
- Status last verified
- May 2025
- First submitted
- 13 Dec 2020
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fanucchi LC, Murphy SM, Surratt H, Kapadia SN, Walsh SL, Grubbs JA, Thornton AC, Nuzzo P, Lofwall MR. Design and protocol of the Buprenorphine plus Outpatient Parenteral Antimicrobial Therapy (B-OPAT) study: a randomized clinical trial of integrated outpatient treatment of opioid use disorder and severe, injection-related infections. Ther Adv Infect Dis. 2022 Jul 11;9:20499361221108005. doi: 10.1177/20499361221108005. eCollection 2022 Jan-Dec.
PubMed 35847566
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
- ClinicalTrials.gov ID
- NCT04677114
- Acronym / sponsor ID
- BOPAT / 60903
- Conditions
- Drug Use, Opioid-use Disorder
- Keywords
- buprenorphine, outpatient, parenteral, antibiotic, OPAT, injection, infectious endocarditis, injection-related
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Laura FanucchiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy of an integrated outpatient treatment model for persons with opioid use disorder and injection related infections. The investigators hypothesize that outpatient antibiotic treatment coupled with comprehensive treatment for opioid use disorder will demonstrate a safe and effective way to manage patients. Results could improve the current protocols for the treatment of individuals with opioid use disorder and severe infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient Parenteral Antibiotic Therapy (OPAT) | Experimental | Drug: Buprenorphine and Outpatient Parenteral Antibiotic TherapyPatients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT). |
| Treatment as Usual (TAU) | Active comparator | Drug: Buprenorphine and standard of care antibiotic treatmentPatients with OUD and severe, injection-related infections (SIRI) will receive usual care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have opioid use disorder
- have a severe injection related infection requiring antibiotics
- willing to accept buprenorphine treatment
- anticipated to be discharged home
- require IV antibiotic therapy
Key exclusion criteria (12 listed)
- stroke or cerebral mycotic aneurysms preventing aortic or mitral valve surgery
- fungal valve IE
- requiring in-patient rehabilitation
- current pregnancy
- hypersensitivity or allergy to buprenorphine
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 |
|---|---|---|
| Buprenorphine and Outpatient Parenteral Antibiotic TherapyAlso: Suboxone or SublocadeParticipants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD. | Drug | Outpatient Parenteral Antibiotic Therapy (OPAT) |
| Buprenorphine and standard of care antibiotic treatmentAlso: Suboxone or SublocadeAll participants will receive treatment of OUD and the infection per usual clinical care. | Drug | Treatment as Usual (TAU) |
Primary outcome
Illicit Opioid Use
Time frame: 12 weeks after hospital discharge
Proportion of urine samples with negative urine drug screen for illicit opioid use
4 secondary outcomes
Completion of Recommended IV Antibiotic Therapy
Time frame: up to 12 weeks (duration of IV antibiotic course as determined by treating physician)
Abstinence From Illicit Opioid
Time frame: 12 weeks after hospital discharge
Injection Drug Use
Time frame: 12 weeks after hospital discharge
Outpatient Treatment Retention
Time frame: 12 weeks after hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35847566Fanucchi LC, Murphy SM, Surratt H, Kapadia SN, Walsh SL, Grubbs JA, Thornton AC, Nuzzo P, Lofwall MR. Design and protocol of the Buprenorphine plus Outpatient Parenteral Antimicrobial Therapy (B-OPAT) study: a randomized clinical trial of integrated outpatient treatment of opioid use disorder and severe, injection-related infections. Ther Adv Infect Dis. 2022 Jul 11;9:20499361221108005. doi: 10.1177/20499361221108005. eCollection 2022 Jan-Dec.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buprenorphine and Outpatient Parenteral Antibiotic Therapy in people with Drug Use and Opioid-use Disorder, run by Laura Fanucchi 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 5 inclusion and 12 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 28 Apr 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Illicit Opioid Use (time frame: 12 weeks after hospital discharge). 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 NCT04677114, 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 28 Apr 2026.