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Hospital care model aims to treat opioid addiction and serious infections together

NCT ID NCT04180020

Disease control Sponsor: Yale University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests a care model where hospitalized adults with opioid use disorder and a serious infection receive long-acting injectable buprenorphine from their infectious disease doctors, alongside infection treatment. The goal is to keep patients on effective medication for opioid use disorder after discharge. Participants are randomly assigned to this new model or to standard care, and researchers track whether they stay on treatment at 12 weeks.

What this could mean

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

Active substance
long-acting injectable buprenorphine
What this could lead to
If successful, this model could improve treatment retention for people with opioid use disorder and serious infections, reducing relapse and complications.
What could go wrong
This is a relatively small study testing a care model, not a new drug. Results may not apply broadly, and the intervention depends on hospital resources and patient willingness.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

171 people

The number who actually took part.

Started

Aug 2020

Finished

Apr 2024

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 years and older

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: * Adults able to provide written informed consent in English or Spanish; * Current hospitalization with a suspected or known bacterial or viral (HIV/HCV/HBV) infection including but not limited to bacteremia, Candidal fungemia, osteomyelitis, endophthalmitis, septic thrombophlebitis, infected pseudoaneurysm, endocarditis, skin/soft tissue infection (SSTI), or septic arthritis; * Current moderate-to-severe OUD (DSM-5); * Willing to accept assignment to either ID/LAB or TAU, and to participate in research follow-up visits. Exclusion Criteria: * Severe medical or psychiatric disability making participation unsafe (e.g. imminent suicide risk); * Pregnancy, planning conception, or breast-feeding for female participants; * Allergy, hypersensitivity or medical contraindication to buprenorphine; * Moderate-severe liver impairment in the judgment of the study investigator; * Preexisting enrollment on methadone or buprenorphine (SL-B) maintenance AND intending to remain on methadone or buprenorphine maintenance upon discharge (patients already under effective treatment for OUD do not represent the target population of untreated OUD patients entering hospitals, nor would we want to disrupt established effective treatment). * Inability or unwillingness of subject to give informed consent.

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease hepatitis B virus infection hepatitis C virus infection HIV infectious disease opiate dependence

As listed by the trial registrant

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

Opioid-use disorder

Contacts and locations

Locations

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Prisma Health

    Greenville, South Carolina, 29650, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520, United States

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