Back to Trials
NCT05790252PHASE3Recruiting

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Washington University School of Medicine

Start Date

11/27/2023

Completion Date

12/1/2026

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.

Eligibility Criteria

Age Range: 18 years to 110 years

Inclusion 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 Exclusion Criteria: * 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

Interventions

DRUG

Buprenorphine Transdermal Matrix Patch

OTHER

Sham patch

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Opioid Use DisorderPregnancy RelatedPregnancy, High RiskPregnancy ComplicationsBuprenorphine Withdrawal

Locations

Washington University in St. Louis

St Louis, Missouri 63124

United States