Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Buprenorphine Transdermal Matrix Patch, Sham patch.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder, Pregnancy Related, Pregnancy, High Risk, Pregnancy Complications. Basic parameters: 18 years — 110 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)
Overview
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.
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.
Primary outcome measures
- Induction withdrawal severity [Time frame: Days 0 through 4]
Secondary outcome measures (3)
- Induction success [Time frame: Days 0 through 7]
- Treatment adherence [Time frame: Days 0 through delivery]
- Recovery success [Time frame: Days 0 through delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Washington University in St. Louis — St Louis
Identifiers
NCT: NCT05790252 · 202209093