Clinical trial NCT04677114: Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
Official title: Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Drug Use
Opioid-use Disorder
Keywords: buprenorphine
outpatient
parenteral
antibiotic
OPAT
injection
infectious endocarditis
injection-related
infection
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-12-21
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Illicit Opioid Use
timeFrame: 12 weeks after hospital discharge
Secondary outcomes:
measure: Completion of Recommended IV Antibiotic Therapy
timeFrame: up to 12 weeks (duration of IV antibiotic course as determined by treating physician)
measure: Abstinence From Illicit Opioid
timeFrame: 12 weeks after hospital discharge
measure: Abstinence from Injection Drug Use
timeFrame: 12 weeks after hospital discharge
measure: Outpatient Treatment Retention
timeFrame: 12 weeks after hospital discharge
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References:
citation: Fanucchi LC, Murphy SM, Surratt H, Kapadia SN, Walsh SL, Grubbs JA, Thornton AC, Nuzzo P, Lofwall MR. Design and protocol of the Buprenorphine plus Outpatient Parenteral Antimicrobial Therapy (B-OPAT) study: a randomized clinical trial of integrated outpatient treatment of opioid use disorder and severe, injection-related infections. Ther Adv Infect Dis. 2022 Jul 11;9:20499361221108005. doi: 10.1177/20499361221108005. eCollection 2022 Jan-Dec.