RecruitingPhase 3NCT05790252

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)


Sponsor

Washington University School of Medicine

Enrollment

40 participants

Start Date

Nov 27, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 110 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

DRUGBuprenorphine Transdermal Matrix Patch

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

OTHERSham 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

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NCT05790252


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