Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Study Overview
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Brief Summary
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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: Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder? 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
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Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)

Conditions
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Buprenorphine Withdrawal, Opioid Use Disorder, Pregnancy Related, Pregnancy, High Risk, Pregnancy Complications

Intervention / Treatment
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* Drug: Buprenorphine Transdermal Matrix Patch
* Other: Sham patch


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bridge Induction Arm<br> | Drug: Buprenorphine Transdermal Matrix Patch<br>* Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.<br>|
| Placebo Comparator: Standard Arm<br> | Other: Sham patch<br>* Bandage applied at time of induction initiation and removed at 48 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction withdrawal severity | Subjective Opioid Withdrawal Scale (SOWS) scores collected during buprenorphine induction. SOWS scores range from 0-64 with higher scores representing worse withdrawal. Mild withdrawal is defined as scores 0-10, moderate as 11-20, and severe as 21+. | Days 0 through 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction success | Induction success, a binary defined by fulling all of the following: attendance at 1 week follow up (yes/no) buprenorphine in urine at initial follow up (positive/negative on urine drug screening) and absence of precipitated withdrawal (yes/no) | Days 0 through 7 | 
| Treatment adherence | defined as percent of urine drug screens positive for buprenorphine throughout pregnancy | Days 0 through delivery | 
| Recovery success | defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care | Days 0 through delivery |