Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Phase 3

Recruiting

• Conditions: Pregnancy Complications; Buprenorphine Withdrawal; Opioid Use Disorder; Pregnancy Related; Pregnancy, High Risk
• Interventions: Drug: Buprenorphine Transdermal Matrix Patch; Other: Sham patch

• Registration Number: NCT05790252
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-03-30
• Study Start: 2023-11-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-12-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bridge Induction Arm	Buprenorphine Transdermal Matrix Patch	-
Standard Arm	Sham patch	-

Primary Outcome Measures

Name	Time	Method
Induction withdrawal severity	Days 0 through 4	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+.

Secondary Outcome Measures

Name	Time	Method
Induction success	Days 0 through 7	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)
Recovery success	Days 0 through delivery	defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care
Treatment adherence	Days 0 through delivery	defined as percent of urine drug screens positive for buprenorphine throughout pregnancy

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States