CompletedPhase 2

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

United States71 participantsStarted 2021-03-16

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Illicit Opioid Use

Timeframe: 12 weeks after hospital discharge

Trial details

NCT IDNCT04677114

SponsorLaura Fanucchi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-06

Results submitted2026-03-04

View on ClinicalTrials.gov More Drug Use trials