Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections (BOPAT)

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 Overview

• Status: Completed
• Conditions: Drug Use; Opioid-use Disorder
• Intervention / Treatment: Drug: Buprenorphine and Outpatient Parenteral Antibiotic Therapy; Drug: Buprenorphine and standard of care antibiotic treatment

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40515
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient Parenteral Antibiotic Therapy (OPAT); 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).	Drug: Buprenorphine and Outpatient Parenteral Antibiotic Therapy; Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.; Other Names: Suboxone or Sublocade
Active Comparator: Treatment as Usual (TAU); Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.	Drug: Buprenorphine and standard of care antibiotic treatment; All participants will receive treatment of OUD and the infection per usual clinical care.; Other Names: Suboxone or Sublocade

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Illicit Opioid Use	Proportion of urine samples with negative urine drug screen for illicit opioid use	12 weeks after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abstinence From Illicit Opioid	Self-reported number of days of illicit opioid abstinence	12 weeks after hospital discharge
Outpatient Treatment Retention	Number of days patients remain in treatment.	12 weeks after hospital discharge
Completion of Recommended IV Antibiotic Therapy	number of patients who completed recommended IV antibiotic therapy	up to 12 weeks (duration of IV antibiotic course as determined by treating physician)
Injection Drug Use	Self-reported number of days of injection use of any drug	12 weeks after hospital discharge

Collaborators and Investigators

• Sponsor: Laura Fanucchi
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): March 6, 2025
• Study Completion (Actual): March 6, 2025

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: buprenorphine; infection; antibiotic; outpatient; injection; parenteral; infectious endocarditis; OPAT; injection-related
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Cardiovascular Diseases; Mental Disorders; Heart Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Cardiovascular Infections; Endocarditis, Bacterial; Endocarditis; Opioid-Related Disorders; Infections; Endocarditis, Subacute Bacterial; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Drug Combinations; Naloxone; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Buprenorphine, Naloxone Drug Combination; Buprenorphine; Sublocade
• Other Study ID Numbers: 60903; 1R01DA048892 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes