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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

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

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

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I need IV antibiotics.

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I am willing to take buprenorphine for treatment.

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I am expected to go home after my hospital stay.

BOPAT Trial 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

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,465 Previous Clinical Trials

2,618,543 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)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do participants have to be under a certain age to qualify for this experiment?

"This particular clinical trial is only for patients that are aged 18 to 99. Out of the 1419 total trials, 311 are for patients younger than 18 and 1098 are for those older than 65."

Answered by AI

How many people are being given this opportunity to participate in the trial?

"Yes, this trial is open and recruiting patients at this time. The listing on clinicaltrials.gov indicates that the first posting was March 16th, 2021 with the most recent update being November 7th, 2022. They are aiming to enroll 90 people total from 1 site."

Answered by AI

Are there any other ongoing research projects that are studying Buprenorphine in combination with Outpatient Parenteral Antibiotic Therapy?

"At the moment, 59 clinical trials are underway to research Buprenorphine and Outpatient Parenteral Antibiotic Therapy. 14 of those active clinical trials are in Phase 3. While most of the studies for Buprenorphine and Outpatient Parenteral Antibiotic Therapy are based in White River Junction, Vermont, 242 different locations are running trials for this treatment."

Answered by AI

What is the most common reason that Buprenorphine and Outpatient Parenteral Antibiotic Therapy are prescribed?

"Buprenorphine and Outpatient Parenteral Antibiotic Therapy can effectively manage opioids. Additionally, it has shown to help with conditions such as pruritus, pain, and septic shock."

Answered by AI

Are there any specific medical requirements to be eligible for this clinical trial?

"This trial requires that patients have an opioid use disorder (OUD) and be between 18-99 years old. Currently, they are looking for 90 individuals to fill these criteria."

Answered by AI

Does the FDA permit Buprenorphine to be used in combination with Outpatient Parenteral Antibiotic Therapy?

"Buprenorphine and Outpatient Parenteral Antibiotic Therapy is still being studied for efficacy, but there is enough evidence to suggest that it is safe."

Answered by AI

Are there any open slots for new patients in this clinical trial?

"Yes, this trial is still looking for participants and has thus far been unable to fill all of the vacancies. The listing on clinicaltrials.gov says that the study was first posted on 3/16/2021 and was last updated on 11/7/2022."

Answered by AI

Recent research and studies

Therapeutic Advances in Infectious DiseaseJournal

Design and Protocol of the Buprenorphine Plus Outpatient Parenteral Antimicrobial Therapy (B-OPAT) Study: A Randomized Clinical Trial of Integrated Outpatient Treatment of Opioid Use Disorder and Severe, Injection-related Infections

Fanucchi, Laura C., Sean M. Murphy, Hilary Surratt, Shashi N. Kapadia, Sharon L. Walsh, James A. Grubbs, Alice C. Thornton, Paul Nuzzo, and Michelle R. Lofwall. 2022. “Design and Protocol of the Buprenorphine Plus Outpatient Parenteral Antimicrobial Therapy (B-OPAT) Study: A Randomized Clinical Trial of Integrated Outpatient Treatment of Opioid Use Disorder and Severe, Injection-related Infections”. Therapeutic Advances in Infectious Disease. SAGE Publications. doi:10.1177/20499361221108005.

clinicaltrials.govStudy

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

Laura Fanucchi 2021. "Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04677114.

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