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

Conditions

Drug Use, Opioid-use Disorder

Keywords

buprenorphine, outpatient, parenteral, antibiotic, OPAT, injection, infectious endocarditis, injection-related, infection

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.

Laura Fanucchi, Alice Thornton, Evelyn Villacorta Cari, Hilary L. Surratt, Paul A. Nuzzo et al. (10 authors)

Open Forum Infectious Diseases2026-01-01

10.1093/ofid/ofaf695.2032

P-107. Serious Injection-Related Infections in Hospitalized Adults with Opioid Use Disorder Enrolled in an Ongoing Randomized Clinical Trial: A Focus on <i>Staphylococcus aureus</i>

Laura Fanucchi, Alice Thornton, Evelyn Villacorta Cari, Ryan P. Mynatt, Connor VanMeter et al. (11 authors)

Open Forum Infectious Diseases2025-01-29

10.1093/ofid/ofae631.314

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

Laura Fanucchi, Sean M. Murphy, Hilary L. Surratt, Shashi N. Kapadia, Sharon Walsh et al. (9 authors)

Therapeutic Advances in Infectious Disease2022-01-015 citations

10.1177/20499361221108005

Interventions

DRUGBuprenorphine and Outpatient Parenteral Antibiotic Therapy

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

DRUGBuprenorphine and standard of care antibiotic treatment

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Illicit Opioid Use	12 weeks after hospital discharge	Proportion of urine samples with negative urine drug screen for illicit opioid use

Secondary

Measure	Time frame	Description
Completion of Recommended IV Antibiotic Therapy	up to 12 weeks (duration of IV antibiotic course as determined by treating physician)	number of patients who completed recommended IV antibiotic therapy
Abstinence From Illicit Opioid	12 weeks after hospital discharge	Self-reported number of days of illicit opioid abstinence
Injection Drug Use	12 weeks after hospital discharge	Self-reported number of days of injection use of any drug
Outpatient Treatment Retention	12 weeks after hospital discharge	Number of days patients remain in treatment.

Countries

United States

Baseline characteristics

Characteristic	—
Age, Continuous	42 Years STANDARD_DEVIATION 9.18
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	67 Participants
Region of Enrollment United States	71 participants
Sex: Female, Male Female	27 Participants
Sex: Female, Male Male	22 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	2 / 36	3 / 35
other Total, other adverse events	32 / 36	30 / 35
serious Total, serious adverse events	14 / 36	20 / 35

Outcome results

None listed