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

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300581
• Other study ID #: 202110063
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Tracey Habrock-Bach, MBA
• Phone: 314-454-8225
• Email: habrockt[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• English speaking males and females

• 18-100 years of age

• 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. *Note that outside of this protocol patients with a history of substance use disorder are considered for discharge on OPAT to skilled nursing facilities or other health-care locations such as BJH extended care. Patients being considered for discharge on OPAT to any of these locations are eligible for inclusion.

• History of injection opioid use within the last 1 year

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

• Started or maintained on medications for opioid use disorder (MOUD) of either methadone, buprenorphine or buprenorphine-naloxone during admission to Barnes-Jewish Hospital

• Have a scheduled follow-up for continuation of medications for opioid use disorder in place prior to discharge. For patients on methadone this should include a scheduled appointment at a methadone clinic, or for patients on buprenorphine this can include a plan for ongoing buprenorphine/ buprenorphine-naloxone based therapy at the Washington University Infectious Diseases Clinic.

• Have met with a health coach or a member of the Bridge To Health team during their inpatient hospitalization and agree to ongoing supportive counseling after discharge.

• Be willing and able to attend in-person clinic visits within 60 days post-discharge at the Washington University Infectious Diseases Clinic.

• Have a working phone number with active voicemail, running water and electricity.

Exclusion Criteria:

• Prisoner status

• Unable to provide own informed consent

• Current homelessness

• Other house-hold members reported as having active untreated substance use disorders

• Unable to attend outpatient appointments. This may include patients who are from rural areas where transportation vouchers may not provide sufficient means of making it to follow-up appointments, or other disability that would preclude transportation (paralysis, broken limbs) where the patient is unable to provide specific details as to how they would arrive at clinic appointments.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Other:
• OPAT for PWID
Observational: 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.

Locations

Country	Name	City	State
United States	Washington Univeristy	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of parenteral antibiotic therapy	Participants will be asked to self-report compliance to the recommended IV antibiotic therapy during a telephone survey performed at completion of antibiotic therapy.	6 weeks patient participation
Primary	Illicit drug use	Participants will have urine drug screens performed at clinic follow-up visit while on OPAT.	6 weeks patient participation
Secondary	Survey Completion		3 month chart review
Secondary	90-day microbiologic failure		3 month chart review
Secondary	90-day Overdose		3 month chart review
Secondary	Sample Size Estimation for Future Study		One year post-enrollment