← Back to Search

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

BOPAT Trial 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.Check my eligibility
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.See study design
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.

BOPAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am taking antibiotics for a severe infection from an injection.
Select...
I need IV antibiotics.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe liver or kidney disease.
Select...
I need to stay in a hospital for physical therapy.
Select...
I have a fungal infection in my heart valve.
Select...
My living situation is not safe for IV antibiotic treatment.
Select...
I cannot have heart valve surgery due to a stroke or brain aneurysm.
Select...
I want to inject medication into my PICC line.
Select...
I have severe heart failure.

BOPAT Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Illicit Opioid Use
Secondary outcome measures
Abstinence From Illicit Opioid
Abstinence from Injection Drug Use
Completion of Recommended IV Antibiotic Therapy
+1 more

BOPAT 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.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,493 Total Patients Enrolled
Laura FanucchiLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Opioid Use Disorder Research Study Groups: Outpatient Parenteral Antibiotic Therapy (OPAT), Treatment as Usual (TAU)
~2 spots leftby Aug 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top