Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
Overview
- Phase
- Phase 2
- Intervention
- Buprenorphine and Outpatient Parenteral Antibiotic Therapy
- Conditions
- Drug Use
- Sponsor
- Laura Fanucchi
- Enrollment
- 71
- Locations
- 2
- Primary Endpoint
- Illicit Opioid Use
- Status
- Completed
- Last Updated
- 4 days ago
Overview
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.
Investigators
Laura Fanucchi
Associate Professor
University of Kentucky
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
Arms & Interventions
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).
Intervention: Buprenorphine and Outpatient Parenteral Antibiotic Therapy
Treatment as Usual (TAU)
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
Intervention: Buprenorphine and standard of care antibiotic treatment
Outcomes
Primary Outcomes
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
- Abstinence From Illicit Opioid(12 weeks after hospital discharge)
- Abstinence from Injection Drug Use(12 weeks after hospital discharge)
- Outpatient Treatment Retention(12 weeks after hospital discharge)
- Completion of Recommended IV Antibiotic Therapy(up to 12 weeks (duration of IV antibiotic course as determined by treating physician))
- Injection Drug Use(12 weeks after hospital discharge)