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Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Recruiting
Female
Phase 3

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Overview

The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The main questions it aims to answer are:

  1. Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder?
  2. Is there a buprenorphine induction method that results in a higher treatment success rate? Under normal circumstances, patients who are planning to start sublingual (under the tongue) buprenorphine for opioid use disorder must first go into withdrawal to start the medication safely. Study participants will be given a buprenorphine patch during the required withdrawal period before starting sublingual treatment, and be surveyed daily by phone to assess their withdrawal symptoms. They will also be followed at prenatal appointments to evaluate treatment success based on urine drug screen results. Researchers will compare patients receiving no buprenorphine patch according to the current standard care protocol.

Eligibility

Inclusion Criteria:

  • Viable pregnancy
  • Meet diagnostic criteria for opioid use disorder
  • Receive prenatal care through opioid use disorder specific clinic at our institution
  • Opioid use within 24 hours prior to presentation
  • Desire treatment with buprenorphine

Exclusion Criteria:

  • Patients already receiving treatment for opioid use disorder
  • History of prior induction attempt with buprenorphine
  • Active withdrawal at time of presentation
  • Medical contraindication to buprenorphine
  • Requiring immediate hospitalization

Study details
    Opioid Use Disorder
    Pregnancy Related
    Pregnancy
    High Risk
    Pregnancy Complications
    Buprenorphine Withdrawal

NCT05790252

Washington University School of Medicine

27 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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