OPAT for Opioid Use Disorder

Recruiting at 1 trial location

Overseen By Laura Marks, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must be taking: Methadone, Buprenorphine

Disqualifiers: Prisoner, Homelessness, Untreated substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether individuals with a history of injection opioid use can safely receive outpatient antibiotic treatments at home while receiving support for opioid use disorder. The study will also explore whether adding social support services, such as case management and health coaching, makes this home treatment more feasible and acceptable. Candidates may be suitable if they have experienced an injection-related infection, are receiving medication for opioid use disorder, and can attend follow-up visits in person after hospital discharge. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches for treating opioid use disorder at home.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on medications for opioid use disorder like methadone or buprenorphine during the trial.

What prior data suggests that this protocol is safe for patients with a history of injection drug use?

A previous study suggested that Outpatient Parenteral Antibiotic Therapy (OPAT) is safe and effective for people who inject drugs. The study found that treatment completion rates, death rates, and catheter-related complications were similar to those in other groups. Another study showed that OPAT, when combined with addiction treatment, is not only feasible but also safe for those with serious infections.

Additionally, a small study demonstrated that OPAT with buprenorphine treatment provided outcomes similar to traditional hospital care. Patients treated at home fared just as well as those treated in a hospital. Overall, research indicates that OPAT can be a safe option for home treatment, especially when paired with support for opioid use disorder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a new way to support people with opioid use disorder who have a history of injection drug use. Unlike traditional treatments that might only focus on addiction, this approach combines Outpatient Parenteral Antibiotic Therapy (OPAT) for managing infections with comprehensive care for substance use disorder. This includes medications for opioid use disorder along with support from health coaches and case managers. By integrating medical treatment with addiction care at home, this method aims to address both the physical and behavioral aspects of opioid use disorder more effectively.

What evidence suggests that home OPAT is effective for patients with opioid use disorder?

Research has shown that receiving antibiotic treatment at home, known as Outpatient Parenteral Antibiotic Therapy (OPAT), can be safe and effective for people who use drugs. In this trial, participants in the observational arm will receive home OPAT while also receiving care for substance use disorder, including medications for opioid use disorder and multidisciplinary health coach and case management support. Studies have found that people who complete OPAT at home achieve success rates similar to those treated in hospitals, even with a history of drug use. For instance, using OPAT along with buprenorphine, a medication for opioid addiction, led to results comparable to traditional hospital care. This suggests that OPAT might be a viable option for treating infections at home while also supporting recovery from opioid addiction. Adding social support, like health coaching and case management, can enhance the practicality of home-based OPAT for these patients. ^{1 5 6 7 8}

Who Is on the Research Team?

Laura Marks, MD, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Evaluated by the joint toxicology/psychiatry addiction medicine consult service during the current inpatient admission

I have met with a health coach or Bridge To Health team member during my hospital stay and agree to continue counseling after leaving.

I have a follow-up plan for my opioid addiction treatment after discharge.

Exclusion Criteria

I am unable to understand and give consent for my own treatment.

I cannot attend in-person appointments due to location or physical disability.

Prisoner status

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home outpatient parenteral antibiotic therapy (OPAT) along with medications for opioid use disorder and multidisciplinary support

6 weeks

Regular home visits and clinic follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including compliance and drug use

4 weeks

1-2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Outpatient Parenteral Antibiotic Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Observational Arm Experimental Treatment 1 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.

Outpatient Parenteral Antibiotic Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Outpatient Parenteral Antibiotic Therapy for:

• Bacterial infections requiring IV antibiotics

Approved in European Union as Outpatient Parenteral Antibiotic Therapy for:

• Bacterial infections requiring IV antibiotics

Approved in Canada as Outpatient Parenteral Antibiotic Therapy for:

• Bacterial infections requiring IV antibiotics

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

A national survey was conducted to assess the practices and attitudes of infectious diseases clinicians in the U.S. regarding outpatient parenteral antimicrobial therapy (OPAT) for people who inject drugs (PWID).

The findings suggest that OPAT is considered a feasible option for treating injection-related infections in PWID, indicating a potential shift towards more accessible treatment methods for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on the Use of Outpatient Parenteral Antibiotic Therapy for People who Inject Drugs: Results From an Online Survey of Infectious Diseases Clinicians. Solomon, DA., Beieler, AM., Levy, S., et al.[2023]

In a study of 68 people who inject drugs (PWID) with serious infections, outpatient parenteral antimicrobial therapy (OPAT) combined with addiction treatment was found to be feasible and safe, with no reported overdoses or deaths.

Of the 20 patients who qualified for the program, all completed their antibiotic treatment, although 30% were readmitted within 30 days and 15% experienced a relapse, indicating the need for ongoing support in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Outpatient Parenteral Antimicrobial Therapy in Conjunction With Addiction Treatment for People Who Inject Drugs. Price, CN., Solomon, DA., Johnson, JA., et al.[2021]

Home-based outpatient parenteral antibiotic therapy (OPAT) is a safe and cost-effective way to provide intravenous antibiotics for complicated infections, allowing patients to recover in a familiar environment while minimizing hospital-related risks.

Persons who inject drugs (PWID) are often excluded from home-based OPAT due to their addiction history, despite evidence suggesting that they can safely complete therapy at home, highlighting a need for a multidisciplinary approach to improve access to care for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rethinking Home-based Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Drugs: An Opportunity for Change in the Time of COVID-19. Jawa, R., Rozansky, H., Clemens, D., et al.[2023]

In a study of 52 hospitalized persons who inject drugs (PWID) receiving outpatient parenteral antibiotic therapy (OPAT), those discharged to home had a high completion rate of their antibiotic courses (81%) without complications, similar to those discharged to skilled nursing or rehabilitation facilities (64%).

The findings suggest that home OPAT can be a safe discharge option for carefully selected PWID, as there was no significant difference in complications between home and SNF/rehab discharges, indicating effective management of their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes According to Discharge Location for Persons Who Inject Drugs Receiving Outpatient Parenteral Antimicrobial Therapy. D'Couto, HT., Robbins, GK., Ard, KL., et al.[2022]

A novel integrated care model for patients with opioid use disorder (OUD) and severe injection-related infections (SIRI) allows for the combination of addiction treatment and outpatient parenteral antimicrobial therapy (OPAT), which is typically not offered to these patients due to concerns about their drug use.

This pilot study highlights the potential for improved management of OUD and SIRI by providing buprenorphine induction during hospitalization and continuing care in an outpatient setting, suggesting a promising approach to address both addiction and infection treatment simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated outpatient treatment of opioid use disorder and injection-related infections: A description of a new care model. Fanucchi, LC., Walsh, SL., Thornton, AC., et al.[2020]

Outpatient parenteral antibiotic therapy (OPAT) was highly effective, achieving a 99% resolution of infection and a 92% eradication rate of the organism in 538 patients, indicating its efficacy in treating infections outside of a hospital setting.

The program demonstrated a high safety profile, with only 8% of patients requiring antibiotic changes, and adverse events leading to hospitalization in just one case, suggesting that OPAT can be a safe and beneficial alternative to traditional inpatient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with a physician-directed, clinic-based program for outpatient parenteral antibiotic therapy in the USA. Tice, AD.[2020]

In a review of 302 outpatient antibiotic therapy courses involving 221 patients, the treatment was successful in 94% of cases, indicating high efficacy for self-directed home infusion of antibiotics.

However, 25% of patients experienced objective adverse events, highlighting the importance of individualized treatment plans and systematic monitoring to ensure safety and optimize outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Out-patient parenteral antibiotic therapy (OPAT): clinical outcomes and adverse events. Berman, SJ., Johnson, EW.[2004]

Outpatient parenteral antibiotic therapy (OPAT) is increasingly used for treating serious infections, but only a minority of infectious disease physicians utilize formal OPAT programs due to inadequate financial and administrative support.

Most patients receive OPAT at home or in skilled nursing facilities, with the latter showing lower patient satisfaction, highlighting the need for multidisciplinary teams to improve communication and care in OPAT programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From sea to shining IV: the current state of OPAT in the United States. Larnard, J., Swords, K., Taupin, D., et al.[2023]

In a study of 339 patients on outpatient parenteral antimicrobial therapy (OPAT), 18% experienced an adverse drug event (ADE), with significant ADEs occurring at a rate of 2.24 per 1000 home-OPAT days, highlighting the need for careful monitoring after discharge.

Longer courses of therapy (14-27 days and at least 28 days) were associated with lower rates of ADEs, while female gender and the use of daptomycin or vancomycin increased the risk, suggesting that specific patient characteristics and treatment types should be considered in monitoring strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates of and Risk Factors for Adverse Drug Events in Outpatient Parenteral Antimicrobial Therapy. Keller, SC., Williams, D., Gavgani, M., et al.[2019]

Outpatient parenteral antibiotic therapy (OPAT) is a safe and effective treatment option for patients, with a low readmission rate of only 5.15% over a 10-year study involving 3435 referrals.

The most common infections treated were Skin and Soft Tissue Infections (61.28%), and the study noted a decline in line-related complications over time, indicating improved safety in the OPAT service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient parenteral antibiotic therapy in a suburban tertiary referral centre in Australia over 10 years. Li, W., Branley, J., Sud, A.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6127783/

Outpatient Parenteral Antimicrobial Therapy Among People ... Results suggest that OPAT may be safe and effective for PWID, with rates of OPAT completion, mortality, and catheter-related complications comparable to rates

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5941140/

Outcomes According to Discharge Location for Persons Who ... The goal of this study was to determine the outcomes of PWID discharged to home or to a skilled nursing or rehabilitation facility (SNF/rehab) with parenteral ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1876034125002874

Implementation of outpatient parenteral antimicrobial ... A pilot randomised clinical trial demonstrated that OPAT combined with buprenorphine treatment achieved similar clinical outcomes to inpatient care in terms of ...

4. academic.oup.com academic.oup.com/ofid/article/7/5/ofaa162/5836987

Home-Based Outpatient Parenteral Antibiotic Therapy at an ... In an urban safety net population including persons using noninjection drugs, home-based OPAT completion rates were similarly high as those of non-drug-using ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743519302361

Integrated outpatient treatment of opioid use disorder and ... A novel, integrated care model was developed where patients with OUD and SIRI receive addiction consultation and buprenorphine induction while hospitalized.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7566637/

Feasibility and Safety of Outpatient Parenteral Antimicrobial ... Outpatient parenteral antimicrobial therapy with addiction treatment may be feasible and safe for PWID with serious infections.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0924857924001808

Safety and efficacy of outpatient parenteral antimicrobial ... Data on various treatment outcomes, including mortality, treatment failure, antimicrobial-related adverse reactions, complications related to the use of ...

8. academic.oup.com academic.oup.com/ofid/article/5/5/ofy056/4992783

Outcomes According to Discharge Location for Persons Who ... The goal of this study was to determine the outcomes of PWID discharged to home or to a skilled nursing or rehabilitation facility (SNF/rehab) ...