BridgeMD
New treatment option for Opioid Use Disorder
Official title Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use
ClinicalTrials.gov ID: NCT06379984
What this study is testing
What is Buprenorphine?
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
- The goal of this clinical trial is to learn if buprenorphine can be started for opioid use disorder with fentanyl use without requiring or precipitating opioid withdrawal. To be eligible, participants must have moderate or severe opioid use disorder and must have fentanyl detected on a urine drug test.
- Phase 2: a mid-size study of how well it works
- 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
- Ages 18 or older
- Male, female, transgender, or non-binary
- DSM-5 criteria for opioid use disorder, moderate to severe
- Fentanyl positive on urine drug test
- Able to provide written informed consent in English prior to any study-related procedure
You likely can't join if
- Pregnancy or actively lactating
- Previously documented hypersensitivity or allergy to buprenorphine or naloxone
- DSM-5 criteria for substance use disorder other than opioid use disorder (e.g., cannabis, cocaine, alcohol)
- Current benzodiazepine use
- Urine drug testing at screening positive for buprenorphine and/or methadone
- AST and/or ALT \>3x upper limit of normal or total bilirubin \>1.5x upper limit of normal
See the full eligibility criteria
- Ages 18 or older
- Male, female, transgender, or non-binary
- DSM-5 criteria for opioid use disorder, moderate to severe
- Fentanyl positive on urine drug test
- Able to provide written informed consent in English prior to any study-related procedure
- Pregnancy or actively lactating
- Previously documented hypersensitivity or allergy to buprenorphine or naloxone
- DSM-5 criteria for substance use disorder other than opioid use disorder (e.g., cannabis, cocaine, alcohol)
- Current benzodiazepine use
- Urine drug testing at screening positive for buprenorphine and/or methadone
- AST and/or ALT \>3x upper limit of normal or total bilirubin \>1.5x upper limit of normal
- eGFR \<30 mL/min
- Use of CYP3A4-metabolized agents such as azole antifungals, macrolides, and protease inhibitors
- High risk of severe medetomidine withdrawal based on drug urine testing for medetomidine, prior withdrawal syndrome requiring intensive care unit admission, and/or patient-reported severe nausea/vomiting during early...
- Significant medical symptoms (e.g. severe respiratory insufficiency), psychiatric symptoms, or dementia that, in the opinion of the investigators, would preclude compliance with the protocol, cooperation in the study...
- Pending legal action that could prohibit participation and/or compliance in study procedures
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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 Philadelphia, Pennsylvania, 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.