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Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Study acronym: Patch BRIDGE
StatusRecruiting
PhasePhase 3
Started2023-11-27
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 14, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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.

Amendment record

Amended 5 times since 2023-03-27; most recent filed 2025-10-10. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2025-10-10
Amendment Study Status v5
2025-03-31
Amendment Study Status v4
2024-07-15
Amendment Study Status, Eligibility v3
2023-07-24
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v2
2023-04-24
Amendment Study Status v1
2023-03-27
Original filing
Trial Details
NCT Number NCT05790252
Lead Sponsor Washington University School of Medicine
Conditions Opioid Use Disorder, Pregnancy Related, Pregnancy, High Risk, Pregnancy Complications, Buprenorphine Withdrawal
Enrollment 40 participants
Start Date 2023-11-27
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-14