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New treatment option for Opioid Use Disorder
Official title High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
ClinicalTrials.gov ID: NCT05589181
What this study is testing
What is High Dose Buprenorphine?
High Dose Buprenorphine is an investigational medicine, given as an once-daily, being studied as a potential treatment for opioid use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This project, involving two distinct clinical trials, tests whether induction to a higher than currently recommended buprenorphine (BUP) induction dose is safe and can improve the proportion of patients who engage in comprehensive addiction services within 7-day of induction. Trial 1 is a head-to-head comparison of the safety, tolerability and feasibility of high dose BUP induction (32 mg).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the...
- 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
You likely can't join if
- 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...
- Be a prisoner or in custody at the time of the index visit
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Newark, New Jersey, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.