Could a stronger starting dose of buprenorphine get more people into opioid addiction treatment?
NCT ID NCT05589181
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tests whether giving a higher-than-standard dose of buprenorphine (a medication for opioid use disorder) in the emergency department is safe and helps more people start addiction treatment within a week. About 140 adults with moderate to severe opioid use disorder who test positive for fentanyl will take part. The goal is to see if a 32 mg dose works better than the usual 12 mg dose at getting patients into ongoing care.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study * Treated in the ED during screening hours * Meet DSM-5 diagnostic criteria for moderate to severe OUD * Clinical Opioid Withdrawal Score (COWS) score ≥ 8 * Urine toxicology positive for fentanyl * Able to speak English or Spanish sufficiently to understand study procedures Exclusion Criteria: * UDS positive for methadone. * Be pregnant determined by urine human chorionic gonadotropin (uHCG) testing * Have an unstable medical or psychiatric condition including suicidality requiring hospitalization * Require ongoing opioids for pain management * Be enrolled in formal addition treatment including by court order anytime within the last 30 days. Patients enrolled in formal addiction treatment not receiving Medications for Opioid Use Disorder (MOUD) are eligible * Be a prisoner or in custody at the time of the index visit * Have any pending legal status or pending legal action that could prohibit full participation in or compliance with study procedures. * Unable to provide one additional point of contact other than themselves * Unwilling to follow study procedures * Have prior enrollment in the current study * Have a known allergy or hypersensitivity to BUP * Have been engaged in formal addiction treatment in the 30-days prior to the ED visit (this does not include addiction treatment or residential programs where MOUD is not given (e.g. behavioral counseling, abstinence programs, NA) * Have received naloxone in the 60-minutes prior to the anticipated first transmucosal (TM) BUP administration * Is undergoing concurrent treatment with another investigational agent or enrolment in another clinical study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Rutgers University Hospital
RECRUITINGNewark, New Jersey, 07103, United States
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