Actively Recruiting

Phase 3
Age: 18Years - 110Years
FEMALE
NCT05790252

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Led by Washington University School of Medicine · Updated on 2025-10-14

40

Participants Needed

1

Research Sites

157 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Who Can Participate

Age: 18Years - 110Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Washington University in St. Louis

St Louis, Missouri, United States, 63124

Actively Recruiting

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Research Team

C

Cassandra J Trammel, MD, MBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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