Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE) (Patch BRIDGE)

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

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Pregnancy Related; Pregnancy, High Risk; Opioid Use Disorder; Buprenorphine Withdrawal
• Intervention / Treatment: Drug: Buprenorphine Transdermal Matrix Patch; Other: Sham patch

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Cassandra J Trammel, MD, MBA; Phone Number: 314-121-1129; Email: cjtrammel@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63124
      • Recruiting
      • Washington University in St. Louis
      • Contact: Jeannie Kelly, MD; Email: jckelly@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Jeannie C Kelly, MD, MS, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Opioid-Related Disorders; Pregnancy Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 202209093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No