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

Primary Purpose

Drug Use, Opioid-use Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine and Outpatient Parenteral Antibiotic Therapy
Buprenorphine and standard of care antibiotic treatment
Sponsored by
Laura Fanucchi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Use focused on measuring buprenorphine, outpatient, parenteral, antibiotic, OPAT, injection, infectious endocarditis, injection-related, infection

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Outpatient Parenteral Antibiotic Therapy (OPAT)

Treatment as Usual (TAU)

Arm Description

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).

Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.

Outcomes

Primary Outcome Measures

Illicit Opioid Use
Proportion of urine samples with negative urine drug screen for illicit opioid use

Secondary Outcome Measures

Completion of Recommended IV Antibiotic Therapy
Proportion of patients who completed of recommended IV antibiotic therapy
Abstinence From Illicit Opioid
Self-reported number of days of illicit opioid abstinence
Abstinence from Injection Drug Use
Self-reported number of days without injection use of any drug
Outpatient Treatment Retention
Number of days patients remain in treatment.

Full Information

First Posted
December 13, 2020
Last Updated
November 7, 2022
Sponsor
Laura Fanucchi
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04677114
Brief Title
Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
Acronym
BOPAT
Official Title
Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Laura Fanucchi
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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 way to manage patients. Results could improve the current protocols for the treatment of individuals with opioid use disorder and severe infections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Use, Opioid-use Disorder
Keywords
buprenorphine, outpatient, parenteral, antibiotic, OPAT, injection, infectious endocarditis, injection-related, infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Outpatient Parenteral Antibiotic Therapy (OPAT)
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine and Outpatient Parenteral Antibiotic Therapy
Other Intervention Name(s)
Suboxone or Sublocade
Intervention Description
Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine and standard of care antibiotic treatment
Other Intervention Name(s)
Suboxone or Sublocade
Intervention Description
All participants will receive treatment of OUD and the infection per usual clinical care.
Primary Outcome Measure Information:
Title
Illicit Opioid Use
Description
Proportion of urine samples with negative urine drug screen for illicit opioid use
Time Frame
12 weeks after hospital discharge
Secondary Outcome Measure Information:
Title
Completion of Recommended IV Antibiotic Therapy
Description
Proportion of patients who completed of recommended IV antibiotic therapy
Time Frame
up to 12 weeks (duration of IV antibiotic course as determined by treating physician)
Title
Abstinence From Illicit Opioid
Description
Self-reported number of days of illicit opioid abstinence
Time Frame
12 weeks after hospital discharge
Title
Abstinence from Injection Drug Use
Description
Self-reported number of days without injection use of any drug
Time Frame
12 weeks after hospital discharge
Title
Outpatient Treatment Retention
Description
Number of days patients remain in treatment.
Time Frame
12 weeks after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Fanucchi
Phone
859-323-1982
Email
laura.fanucchi@uky.edu
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40515
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea N McNaughton
Phone
859-218-0714
First Name & Middle Initial & Last Name & Degree
Connor M VanMeter
Phone
859-562-0566
First Name & Middle Initial & Last Name & Degree
Laura C Fanucchi, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35847566
Citation
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.
Results Reference
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Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections

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