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ER study tests higher buprenorphine dose to boost opioid treatment success

NCT ID NCT06494904

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a higher starting dose of buprenorphine in the emergency room helps more people with opioid use disorder engage in treatment within 10 days. It also looks at whether the higher dose reduces cravings, withdrawal symptoms, and use of illicit opioids. The trial enrolls 360 adults with moderate to severe opioid use disorder who are currently not in treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

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 65 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: All patients enrolled into the study must: 1. Be 18-65 years of age. 2. Be treated in the ED during study screening hours. 3. Meet DSM-5 diagnostic criteria for moderate to severe OUD. 4. Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment). 5. Have a urine toxicology test that is positive for opioids. 6. Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: All patients enrolled into the study must not: 1. Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit. 2. Have a known hypersensitivity reaction to buprenorphine/naloxone 3. Be actively suicidal or severely cognitively impaired precluding informed consent. 4. Require ongoing prescription for opioid analgesics. 5. Have a physical exam or reported history consistent with severe liver failure 6. Have a positive urine test for methadone and reported use in the past 72 hours 7. Be a prisoner or in police custody at the time of index ED visit. 8. Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments) 9. Have prior enrollment in the current study. 10. Receiving MOUD treatment within the past 7 days. 11. Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit 12. Have a respiratory rate \<8 or oxygen saturation \<93% 13. Be a participant in any other clinical trial in which medications are being delivered or the use of an investigational drug or device within the last 30 days

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Conditions

The condition(s) this trial relates to.

opiate dependence

As listed by the trial registrant

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

Opioid-use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cooper University Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Highland Hospital

    RECRUITING

    Oakland, California, 94602, United States

  • Maine Medical Center

    RECRUITING

    Portland, Maine, 04102, United States

  • San Leandro Hospital

    RECRUITING

    San Leandro, California, 94578, United States

  • University of Utah Hospital

    RECRUITING

    Salt Lake City, Utah, 84132, United States

More trials for these conditions

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