drugset / Trial / NCT05790252

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

NCT05790252

Phase 3 Recruiting 40 enrolled Washington University School of Medicine
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-11-27
Primary completion
2026-07-01
Completion
2026-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified Other