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Opioid Partial Agonist

Buprenorphine + Antibiotics for Opioid Use Disorder and Infections (BOPAT Trial)

Phase 2

Recruiting

Research Sponsored by Laura Fanucchi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

have a severe injection related infection requiring antibiotics

require IV antibiotic therapy

Must not have

end-stage liver or renal disease

requiring in-patient rehabilitation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after hospital discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an outpatient model combining antibiotic treatment and comprehensive care for opioid addiction is safe and effective.

Who is the study for?

This trial is for individuals with opioid use disorder who also have severe injection-related infections requiring IV antibiotics. Participants must be willing to take buprenorphine, anticipate being discharged home, and live within a 60-minute drive of Lexington, KY. Pregnant individuals or those with certain medical conditions like end-stage organ disease or heart failure are excluded.

What is being tested?

The study is testing an integrated outpatient treatment combining Buprenorphine for opioid addiction and either standard care or Outpatient Parenteral Antibiotic Therapy for severe infections. The goal is to see if this approach safely manages patients' conditions outside the hospital.

What are the potential side effects?

Possible side effects include reactions to Buprenorphine such as dizziness, sleepiness, nausea, and potential allergic responses. Antibiotics may cause digestive issues, allergic reactions, and in some cases more serious side effects depending on the individual's health condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am taking antibiotics for a severe infection from an injection.

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I need IV antibiotics.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe liver or kidney disease.

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I need to stay in a hospital for physical therapy.

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I have a fungal infection in my heart valve.

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My living situation is not safe for IV antibiotic treatment.

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I cannot have heart valve surgery due to a stroke or brain aneurysm.

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I want to inject medication into my PICC line.

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I have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after hospital discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after hospital discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Illicit Opioid Use

Secondary study objectives

Abstinence From Illicit Opioid

Abstinence from Injection Drug Use

Completion of Recommended IV Antibiotic Therapy

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Outpatient Parenteral Antibiotic Therapy (OPAT)Experimental Treatment1 Intervention

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).

Group II: Treatment as Usual (TAU)Active Control1 Intervention

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

0 / 9Eligibility criteria met