High dose buprenorphine induction for opioid use disorder in the emergency department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of a higher induction dose of buprenorphine (BUP) for patients with opioid use disorder in emergency departments. It consists of two trials: the first compares the safety and tolerability of a 32 mg dose against the standard 12 mg dose, while the second is a pilot study assessing the engagement in addiction treatment within 7 days post-induction. Participants will be monitored closely for any adverse effects during and after the dosing. The study aims to determine if a higher dose can improve patient outcomes and engagement in treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Rutgers University Hospital
  Newark, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Ethan Cowan, MD, MS — The Rutgers Addiction Research Center
• Study coordinator: Ethan Cowan, MD, MS
• Email: ethan.cowan@rutgers.edu
• Phone: (917) 447-4964

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CBD for Opioid Dependence and Pain on Buprenorphine

  This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.

  Recruiting Early Phase 1 Yale University · West Haven, Connecticut · NCT07886606

• Cebranopadol for opioid withdrawal in adults with chronic pain

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• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

  This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.

  Recruiting Duke University · Durham, North Carolina · NCT07810322

• CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand

  This study tests CB1 receptor availability in people with opioid use disorder starting opioid agonist therapy and compares them with healthy adults.

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• STORC: Training a support person plus patient navigation after birth

  We’re testing whether training a designated support person and using patient navigation after delivery helps people with opioid use disorder build recovery resources and stay in treatment.

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• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

  A digital platform run by peer recovery supporters will be tested to help adults with opioid use disorder who are on buprenorphine or methadone stay in treatment and improve outcomes.

  Recruiting Rhode Island Hospital · Providence, Rhode Island · NCT07778394

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.