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RECRUITINGPhase 3INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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