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

Laura Fanucchi

Status and phase: Completed; Phase 2

Conditions: Opioid-use Disorder; Drug Use

Treatments: Drug: Buprenorphine and standard of care antibiotic treatment; Drug: Buprenorphine and Outpatient Parenteral Antibiotic Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04677114

1R01DA048892 (U.S. NIH Grant/Contract)

60903

Details and patient eligibility

About

This study will assess the efficacy of an integrated outpatient treatment model for persons with opioid use disorder and injection related infections. The investigators hypothesize that outpatient antibiotic treatment coupled with comprehensive treatment for opioid use disorder will demonstrate a safe and effective way to manage patients. Results could improve the current protocols for the treatment of individuals with opioid use disorder and severe infections.

Enrollment: 71 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• have opioid use disorder
• have a severe injection related infection requiring antibiotics
• willing to accept buprenorphine treatment
• anticipated to be discharged home
• require IV antibiotic therapy

Exclusion criteria

• stroke or cerebral mycotic aneurysms preventing aortic or mitral valve surgery
• fungal valve IE
• requiring in-patient rehabilitation
• current pregnancy
• hypersensitivity or allergy to buprenorphine
• class III or IV heart failure
• end-stage liver or renal disease
• any condition that may prevent the volunteer from safely participating in the study
• self-report of desire to inject into the PICC line
• pending legal action that could interfere with study participation
• unsafe or unstable environment precluding safe administration of IV antibiotics
• living more than a 60 minute drive outside of Lexington, KY

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

71 participants in 2 patient groups

Outpatient Parenteral Antibiotic Therapy (OPAT)

Experimental group

Description:

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).

Treatment:

Drug: Buprenorphine and Outpatient Parenteral Antibiotic Therapy

Treatment as Usual (TAU)

Active Comparator group

Description:

Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.

Treatment:

Drug: Buprenorphine and standard of care antibiotic treatment