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Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)
Sponsor: Washington University School of Medicine
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.
Official title: Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)
Key Details
Gender
FEMALE
Age Range
18 Years - 110 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-11-27
Completion Date
2026-12-01
Last Updated
2025-10-14
Healthy Volunteers
No
Conditions
Interventions
Buprenorphine Transdermal Matrix Patch
Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.
Sham patch
Bandage applied at time of induction initiation and removed at 48 hours.
Locations (1)
Washington University in St. Louis
St Louis, Missouri, United States