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

NCT04677114 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2026-04-28

Study results available
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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

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Laura Fanucchi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2025-03-06
Completion
2025-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04677114 on ClinicalTrials.gov