Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Last updated: March 31, 2025
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

3

Condition

Opioid Use Disorder

Pregnancy Complications

Treatment

Buprenorphine Transdermal Matrix Patch

Sham patch

Clinical Study ID

NCT05790252
202209093
  • Ages 18-110
  • Female

Study Summary

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 Criteria

Inclusion

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

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 Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Buprenorphine Transdermal Matrix Patch
Phase: 3
Study Start date:
November 27, 2023
Estimated Completion Date:
July 01, 2026

Connect with a study center

  • Washington University in St. Louis

    Saint Louis, Missouri 63124
    United States

    Active - Recruiting

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