Phase 2
Completed N=71
Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
Drug Use · Opioid Use Disorder
Source: ClinicalTrials.gov NCT04677114 ↗
Enrolled (actual)
71
Serious AEs
47.9%
Results posted
Mar 2026
Primary outcomePrimary: Illicit Opioid Use — 0.434; 0.360 Proportion of UDS samples
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Illicit Opioid Use |
0.434; 0.360 | — |
| SECONDARY Completion of Recommended IV Antibiotic Therapy |
27; 18 | — |
| SECONDARY Abstinence From Illicit Opioid |
66.7; 63.0 | — |
| SECONDARY Injection Drug Use |
3.8; 7.1 | — |
| SECONDARY Outpatient Treatment Retention |
81.4; 62.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT04677114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.