OPAT for Opioid Use Disorder

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

Trial Summary

What is the purpose of this trial?

Patients with a history of injection drug use are historically excluded from home outpatient parenteral antibiotic therapy programs. Recent small pilot programs have demonstrated that these patients may be safely included in home OPAT programs when they are provided with medications for opioid use disorder such as suboxone or methadone. However nothing is known about the effect of additional social support services including case management and health coach navigation on the feasibility and acceptibility of home OPAT programs for persons who inject drugs. This observational study will provide pilot data on the feasibility of such a program in anticipation of a larger scale trial.

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 data supports the effectiveness of the treatment Outpatient Parenteral Antibiotic Therapy (OPAT) for opioid use disorder?

Research suggests that OPAT can be safely and effectively used for people who inject drugs, allowing them to complete necessary antibiotic treatments at home, which can reduce healthcare costs and minimize hospital-related infection risks. Additionally, integrating OPAT with addiction treatment has shown promise in managing both infections and opioid use disorder. ^{1 2 3 4 5}

Is outpatient parenteral antibiotic therapy (OPAT) generally safe for humans?

OPAT is generally considered safe for humans when patients are carefully selected and monitored, with studies showing a high success rate and low incidence of adverse events, such as rashes. Most patients report satisfaction with the treatment, and adverse events are usually manageable. ^{1 6 7 8 9}

How is the OPAT treatment unique for opioid use disorder?

OPAT (Outpatient Parenteral Antibiotic Therapy) is unique because it allows people with opioid use disorder to receive necessary intravenous antibiotics at home, reducing hospital stays and exposure to infections, while also addressing the challenges of providing care to those with a history of drug use. ^{1 2 5 8 10}

Research Team

Laura Marks, MD, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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 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]

References

1. Netherlands 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Outpatient Parenteral Antimicrobial Therapy in Conjunction With Addiction Treatment for People Who Inject Drugs. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes According to Discharge Location for Persons Who Inject Drugs Receiving Outpatient Parenteral Antimicrobial Therapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Integrated outpatient treatment of opioid use disorder and injection-related infections: A description of a new care model. [2020]

5. United States 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. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Out-patient parenteral antibiotic therapy (OPAT): clinical outcomes and adverse events. [2004]

8. Germany pubmed.ncbi.nlm.nih.gov

Outpatient parenteral antibiotic therapy in a suburban tertiary referral centre in Australia over 10 years. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Rates of and Risk Factors for Adverse Drug Events in Outpatient Parenteral Antimicrobial Therapy. [2019]

10. England pubmed.ncbi.nlm.nih.gov

From sea to shining IV: the current state of OPAT in the United States. [2023]