Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Description

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

Opioid Use Disorder, Pregnancy Related, Pregnancy, High Risk, Pregnancy Complications, Buprenorphine Withdrawal

Study Overview

Study Details

Study 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.

Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Saint Louis

Washington University in St. Louis, Saint Louis, Missouri, United States, 63124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 110 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Washington University School of Medicine,

Jeannie C Kelly, MD, MS, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

2026-01-01