NCT04677114

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Laura Fanucchi · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug Use
• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Buprenorphine and Outpatient Parenteral Antibiotic Therapy	Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.
DRUG	Buprenorphine and standard of care antibiotic treatment	All participants will receive treatment of OUD and the infection per usual clinical care.

Timeline

• Start date: 2021-03-16
• Primary completion: 2025-03-06
• Completion: 2025-03-06
• First posted: 2020-12-21
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study