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

Sponsor

Laura Fanucchi (Other)

Overall Status

Recruiting

CT.gov ID

NCT04677114

Collaborator

(none)

Enrollment

Location

Arms

45.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Use Opioid-use Disorder	Drug: Buprenorphine and Outpatient Parenteral Antibiotic Therapy Drug: Buprenorphine and standard of care antibiotic treatment	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 16, 2021

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Outpatient Parenteral Antibiotic Therapy (OPAT) 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).	Drug: Buprenorphine and Outpatient Parenteral Antibiotic Therapy Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD. Other Names: Suboxone or Sublocade
Active Comparator: Treatment as Usual (TAU) Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.	Drug: Buprenorphine and standard of care antibiotic treatment All participants will receive treatment of OUD and the infection per usual clinical care. Other Names: Suboxone or Sublocade

Arm

Intervention/Treatment

Experimental: Outpatient Parenteral Antibiotic Therapy (OPAT)

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).

Drug: Buprenorphine and Outpatient Parenteral Antibiotic Therapy

Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.

Other Names:

Suboxone or Sublocade

Active Comparator: Treatment as Usual (TAU)

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

Drug: Buprenorphine and standard of care antibiotic treatment

All participants will receive treatment of OUD and the infection per usual clinical care.

Other Names:

Suboxone or Sublocade

Outcome Measures

Primary Outcome Measures

Illicit Opioid Use [12 weeks after hospital discharge]
Proportion of urine samples with negative urine drug screen for illicit opioid use

Secondary Outcome Measures

Completion of Recommended IV Antibiotic Therapy [up to 12 weeks (duration of IV antibiotic course as determined by treating physician)]
Proportion of patients who completed of recommended IV antibiotic therapy
Abstinence From Illicit Opioid [12 weeks after hospital discharge]
Self-reported number of days of illicit opioid abstinence
Abstinence from Injection Drug Use [12 weeks after hospital discharge]
Self-reported number of days without injection use of any drug
Outpatient Treatment Retention [12 weeks after hospital discharge]
Number of days patients remain in treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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