Status:
COMPLETED
Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
Lead Sponsor:
Laura Fanucchi
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Drug Use
Opioid-use Disorder
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
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 ant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2025
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04677114
Start Date
March 16 2021
End Date
March 6 2025
Last Update
May 14 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40515