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

NCT04677114 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 609031R01DA048892
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Use; Opioid-use Disorder

Keywords

buprenorphine; outpatient; parenteral; antibiotic; OPAT; injection; infectious endocarditis; injection-related; infection

Outcome Measures

Primary Outcomes (1)

• Illicit Opioid Use

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

  12 weeks after hospital discharge

Secondary Outcomes (4)

• Completion of Recommended IV Antibiotic Therapy

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

• Abstinence From Illicit Opioid

  12 weeks after hospital discharge

• Injection Drug Use

  12 weeks after hospital discharge

• Outpatient Treatment Retention

  12 weeks after hospital discharge

Study Arms (2)

Outpatient Parenteral Antibiotic Therapy (OPAT)

EXPERIMENTAL

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

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Drug: Buprenorphine and standard of care antibiotic treatment

Interventions

Buprenorphine and Outpatient Parenteral Antibiotic Therapy DRUG

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

Also known as: Suboxone or Sublocade

Outpatient Parenteral Antibiotic Therapy (OPAT)

Buprenorphine and standard of care antibiotic treatment DRUG

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

Also known as: Suboxone or Sublocade

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laura Fanucchi: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40515, United States

Location

Related Publications (1)

• 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.

  PMID: 35847566 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Endocarditis, Subacute Bacterial; Infections

Interventions

Buprenorphine; Buprenorphine, Naloxone Drug Combination; Sublocade

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Endocarditis, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Cardiovascular Infections; Cardiovascular Diseases; Endocarditis; Heart Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Michelle Lofwall
• Organization: University of Kentucky

michelle.lofwall@uky.edu

859-323-9321

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 21, 2020
• Study Start: March 16, 2021
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: April 28, 2026
• Results First Posted: March 27, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)