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RECRUITING
NCT05790252
PHASE3

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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

Interventions

DRUG

Buprenorphine Transdermal Matrix Patch

Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.

OTHER

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