# DAT- Integrated Outpatient Treatment of Opioid Use Disorder and Injection-Related Infections

> **NIH NIH R01** · UNIVERSITY OF KENTUCKY · 2022 · $700,065

## Abstract

ABSTRACT
DAT18-06: Hospitalizations for complications of opioid use disorder (OUD), like infectious endocarditis (IE) and
other severe, injection-related infections (SIRI), have increased dramatically along with the opioid epidemic.
Persons with OUD hospitalized with SIRI, often remain inpatient to complete prolonged intravenous (IV)
antibiotic courses due to several assumptions such as 1) if outpatient, patients will inject illicit drugs into the IV
catheter and will fail to complete prescribed antibiotic regimens, and 2) if inpatient, patients will not inject drugs
because of the increased supervision and will complete the antibiotic regimen. No evidence supports these
assumptions, and unfortunately, the inpatient stay is not only very costly to the healthcare system, but
infrequently includes comprehensive OUD treatment. In contrast, outpatient parenteral antibiotic therapy
(OPAT) via a peripherally-inserted central catheter (PICC) is the standard of care for continuing IV medications
for patients without injection drug use (IDU) once medically stable, and is commonly used in treatment
infections requiring prolonged IV antibiotics. OPAT is cost-effective, associated with improved patient
satisfaction, and with decreased risks of hospital-acquired infections. Development of innovative outpatient
clinical models is urgently needed to improve the management and transition plan of persons with OUD and
SIRI, given the costs and risks associated with prolonged hospitalizations. We conducted a successful pilot,
proof-of-concept, randomized, study to establish the safety and feasibility of discharging inpatients with OUD
and SIRI to complete IV antibiotics in an innovative, integrated, outpatient model combining BUP treatment
with OPAT. This 12-week outpatient, randomized, parallel-group study builds on our preliminary work to
demonstrate efficacy of the integrated outpatient care model (B-OPAT: BUP treatment with OPAT). Patients
with OUD and SIRI will be randomized (1:1) to either B-OPAT (n=45) or treatment-as-usual (TAU) (n=45) and
compared on the primary outcome of the proportion of urine samples negative for illicit opioids, and on critical
secondary outcomes including completion of recommended IV antibiotic therapy, self-reported number of days
of illicit opioid abstinence and retention in outpatient treatment. The study will also incorporate a
comprehensive economic evaluation of the integrated outpatient care model as well as a qualitative
investigation to inform future implementation and dissemination. These results will demonstrate the efficacy
and cost effectiveness of an integrated outpatient care model to provide outpatient treatment of OUD and SIRI
after hospitalization.

## Key facts

- **NIH application ID:** 10461109
- **Project number:** 5R01DA048892-03
- **Recipient organization:** UNIVERSITY OF KENTUCKY
- **Principal Investigator:** Laura Fanucchi
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $700,065
- **Award type:** 5
- **Project period:** 2020-09-30 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10461109

## Citation

> US National Institutes of Health, RePORTER application 10461109, DAT- Integrated Outpatient Treatment of Opioid Use Disorder and Injection-Related Infections (5R01DA048892-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10461109. Licensed CC0.

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