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New study combines addiction treatment and IV antibiotics outside the hospital

NCT ID NCT04677114

Disease control Sponsor: Laura Fanucchi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether people with opioid use disorder and severe injection-related infections can be safely treated at home with antibiotics and buprenorphine (a medication for opioid use disorder). 71 participants were enrolled. The goal was to see if this integrated approach reduces illicit opioid use and helps patients complete their antibiotic treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
buprenorphine (Suboxone or Sublocade) and intravenous antibiotics
What this could lead to
If successful, this approach could offer a safe, effective way to treat both opioid use disorder and severe infections without requiring a hospital stay.
What could go wrong
This is a small Phase 2 trial with only 71 participants, so results may not apply to everyone. The treatment requires careful monitoring and may not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

71 people

The number who actually took part.

Started

Mar 2021

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Infections opiate dependence subacute bacterial endocarditis substance abuse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Drug use Opioid-use disorder

Contacts and locations

Locations

  • University of Kentucky

    Lexington, Kentucky, 40515, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.