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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40515
Contact:
Andrea N McNaughton
859-218-0714

More Details

NCT ID
NCT04677114
Status
Recruiting
Sponsor
Laura Fanucchi

Study Contact

Laura Fanucchi
859-323-1982
laura.fanucchi@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.