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

Phase 2

Completed

• Conditions: Drug Use; Opioid-use Disorder
• Interventions: Drug: Buprenorphine and Outpatient Parenteral Antibiotic Therapy; Drug: Buprenorphine and standard of care antibiotic treatment

• Registration Number: NCT04677114
• Lead Sponsor: Laura Fanucchi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-21
• Study Start: 2021-03-16
• Primary Completion: 2025-03-06
• Study Completion: 2025-03-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient Parenteral Antibiotic Therapy (OPAT)	Buprenorphine and Outpatient Parenteral Antibiotic Therapy	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).
Treatment as Usual (TAU)	Buprenorphine and standard of care antibiotic treatment	Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.

Primary Outcome Measures

Name	Time	Method
Illicit Opioid Use	12 weeks after hospital discharge	Proportion of urine samples with negative urine drug screen for illicit opioid use

Secondary Outcome Measures

Name	Time	Method
Completion of Recommended IV Antibiotic Therapy	up to 12 weeks (duration of IV antibiotic course as determined by treating physician)	Proportion of patients who completed of recommended IV antibiotic therapy
Abstinence From Illicit Opioid	12 weeks after hospital discharge	Self-reported number of days of illicit opioid abstinence
Abstinence from Injection Drug Use	12 weeks after hospital discharge	Self-reported number of days without injection use of any drug
Outpatient Treatment Retention	12 weeks after hospital discharge	Number of days patients remain in treatment.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States