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Antibiotic

OPAT for Opioid Use Disorder

N/A

Recruiting

Led By Laura Marks, MD, PhD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Being considered for discharge from Barnes-Jewish Hospital on OPAT (PICC/Midline only) for a serious injection-related infection including endocarditis, osteomyelitis, discitis, septic arthritis, epidural abscess, or S. aureus bacteremia

Aged between 18-100 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year post-enrollment

Awards & highlights

Study Summary

This trial will study if it is safe for patients who use drugs injection to be included in a home OPAT program, when given medications for opioid use disorder.

Who is the study for?

This trial is for adults aged 18-100 with a history of opioid injection who are being discharged from Barnes-Jewish Hospital on antibiotics due to serious infections. They must be on or starting treatment for opioid use disorder, have follow-up care arranged, and agree to health coaching. Participants need a working phone, home utilities, and the ability to attend clinic visits. Those who can't consent, are homeless, imprisoned or unable to travel for appointments due to location or disability cannot join.Check my eligibility

What is being tested?

The study is testing if outpatient antibiotic therapy at home (OPAT) is workable for people who inject opioids when combined with addiction treatments like suboxone/methadone and extra support services such as case management. It's an observational study aiming to gather initial data before launching a larger trial.See study design

What are the potential side effects?

While specific side effects aren't listed here since it's an observational study of existing therapies, generally OPAT may include risks like infection at the infusion site while medications for opioid use disorder can cause symptoms like nausea, drowsiness or constipation.

Eligibility Criteria

Inclusion Criteria

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

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I am being discharged with a PICC or Midline for a serious infection.

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I am between 18 and 100 years old.

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I am on methadone, buprenorphine, or buprenorphine-naloxone for opioid addiction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year post-enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year post-enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post-enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Completion of parenteral antibiotic therapy

Illicit drug use

Secondary outcome measures

90-day Overdose

90-day microbiologic failure

Sample Size Estimation for Future Study

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Observational ArmExperimental Treatment1 Intervention

Patients with a history of injection opioid use will receive home OPAT while also receiving substance use disorder care including medications for opioid use disorder and multidisciplinary health coach and case management support.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,756 Total Patients Enrolled

Laura Marks, MD, PhDPrincipal InvestigatorWashington University School of Medicine

Media Library

Outpatient Parenteral Antibiotic Therapy (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05300581 — N/A

Opioid Use Disorder Research Study Groups: Observational Arm

Opioid Use Disorder Clinical Trial 2023: Outpatient Parenteral Antibiotic Therapy Highlights & Side Effects. Trial Name: NCT05300581 — N/A

Outpatient Parenteral Antibiotic Therapy (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05300581 — N/A

Frequently Asked Questions

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

How many individuals are involved in this trial?

"Affirmative. Clinicaltrials.gov reports that this clinical trial is actively recruiting patients; it was first published on March 16th 2022 and has seen its most recent update as of today's date (March 18th). 50 people are in need of being recruited from a single medical facility."

Answered by AI

Are there any enrollment opportunities available to participants at this time?

"Indeed, the trial is actively recruiting according to records on clinicaltrials.gov; it was first posted on March 16th 2022 and was last updated two days later. This study requires 50 patients from one site to participate."

Answered by AI

Am I eligible to join the research study?

"This medical trial is seeking 50 English speaking males and females, aged 18 to 100, with a history of opioid abuse. In addition to these requirements, patients must be discharged from Barnes-Jewish Hospital on OPAT (PICC/Midline only) for an injection related infection such as endocarditis or septic arthritis; have used opioids in the last year; been evaluated by the joint toxicology/psychiatry addiction medicine consult service during their current hospital admission; started or maintained medication for opioid use disorder while at BJH with plans to continue treatment post-discharge either through methadone clinics or Washington University Infectious Diseases"

Answered by AI

Does this investigation accept enrollees that are over sixty years of age?

"Per the eligibility standards, potential participants must fall between 18 and 100 years of age. For those younger or older than this range, there are 22 trials for minors and 240 for seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids

2022. "Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05300581.