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

• Buprenorphine and Outpatient Parenteral Antibiotic Therapy (Drug), also known as Suboxone or Sublocade: Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.
• Buprenorphine and standard of care antibiotic treatment (Drug), also known as Suboxone or Sublocade: All participants will receive treatment of OUD and the infection per usual clinical care.

Primary outcomes

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

Secondary outcomes

• 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.

Sex: All, ages: 18 Years to 99 Years

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

Participant flow

Outcome results

• Illicit Opioid Use (Primary), Number, Proportion of UDS samples: Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT) 0.434; Treatment as Usual (TAU) 0.360
• Completion of Recommended IV Antibiotic Therapy (Secondary), Count of participants, Participants: Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT) 27; Treatment as Usual (TAU) 18
• Abstinence From Illicit Opioid (Secondary), Mean, Days: Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT) 66.7 +/- 4.4; Treatment as Usual (TAU) 63.0 +/- 5.5
• Injection Drug Use (Secondary), Mean, Days: Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT) 3.8 +/- 1.6; Treatment as Usual (TAU) 7.1 +/- 3.9
• Outpatient Treatment Retention (Secondary), Mean, Days: Buprenorphine Plus Outpatient Parenteral Antibiotic Therapy (BOPAT) 81.4 +/- 4.8; Treatment as Usual (TAU) 62.3 +/- 6.9

Adverse events

Time frame: From enrollment until end of follow-up, up to 6 months from index hospitalization discharge

Serious adverse events by term

Other adverse events by term

24 more terms not shown.

• 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. PMID 35847566

• Study Protocol (PDF, 2025-10-14)
• Statistical Analysis Plan (PDF, 2024-07-11)
• Informed Consent Form (PDF, 2024-07-11)

NIH grants: R01DA048892