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

Study Overview
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Brief Summary
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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.

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

Conditions
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Drug Use, Opioid-use Disorder

Intervention / Treatment
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* Drug: Buprenorphine and Outpatient Parenteral Antibiotic Therapy
* Drug: Buprenorphine and standard of care antibiotic treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient Parenteral Antibiotic Therapy (OPAT)<br>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<br>* Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.<br>* Other names: Suboxone or Sublocade;|
| Active Comparator: Treatment as Usual (TAU)<br>Patients with OUD and severe, injection-related infections (SIRI) will receive usual care. | Drug: Buprenorphine and standard of care antibiotic treatment<br>* All participants will receive treatment of OUD and the infection per usual clinical care.<br>* Other names: Suboxone or Sublocade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Illicit Opioid Use | Proportion of urine samples with negative urine drug screen for illicit opioid use | 12 weeks after hospital discharge | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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buprenorphine, outpatient, parenteral, antibiotic, OPAT, injection, infectious endocarditis, injection-related, infection