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OpenTrials
Completed

NCT Number: NCT04677114

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

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.

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Key information

Conditions

Drug Use Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Cardiovascular Infections Chemically-Induced Disorders Endocarditis Endocarditis, Bacterial Endocarditis, Subacute Bacterial Gram-Positive Bacterial Infections Heart Diseases Infections Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Opioid-use Disorder Streptococcal Infections Substance-Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Kentucky

Lexington, Kentucky, 40515, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buprenorphine and Outpatient Parenteral Antibiotic Therapy

Drug

Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.

Other names: Suboxone or Sublocade

Buprenorphine and standard of care antibiotic treatment

Drug

All participants will receive treatment of OUD and the infection per usual clinical care.

Other names: Suboxone or Sublocade

Primary outcomes

  1. Illicit Opioid Use

    Time frame: 12 weeks after hospital discharge

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

Secondary outcomes

  1. Completion of Recommended IV Antibiotic Therapy

    Time frame: up to 12 weeks (duration of IV antibiotic course as determined by treating physician)

    number of patients who completed recommended IV antibiotic therapy

  2. Abstinence From Illicit Opioid

    Time frame: 12 weeks after hospital discharge

    Self-reported number of days of illicit opioid abstinence

  3. Injection Drug Use

    Time frame: 12 weeks after hospital discharge

    Self-reported number of days of injection use of any drug

  4. Outpatient Treatment Retention

    Time frame: 12 weeks after hospital discharge

    Number of days patients remain in treatment.

Sponsors and collaborators

Lead sponsor

Laura Fanucchi

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: BOPAT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2020
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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