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

Primary Purpose

Opioid Use Disorder, Pregnancy Related, Pregnancy, High Risk

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine Transdermal Matrix Patch
Sham patch
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University in St. LouisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bridge Induction Arm

Standard Arm

Arm Description

Outcomes

Primary Outcome Measures

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+.

Secondary Outcome Measures

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)
Treatment adherence
defined as percent of urine drug screens positive for buprenorphine throughout pregnancy
Recovery success
defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care

Full Information

First Posted
March 13, 2023
Last Updated
July 24, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05790252
Brief Title
Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)
Acronym
Patch BRIDGE
Official Title
Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Pregnancy Related, Pregnancy, High Risk, Pregnancy Complications, Buprenorphine Withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bridge Induction Arm
Arm Type
Experimental
Arm Title
Standard Arm
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Buprenorphine Transdermal Matrix Patch
Intervention Description
Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.
Intervention Type
Other
Intervention Name(s)
Sham patch
Intervention Description
Bandage applied at time of induction initiation and removed at 48 hours.
Primary Outcome Measure Information:
Title
Induction withdrawal severity
Description
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+.
Time Frame
Days 0 through 4
Secondary Outcome Measure Information:
Title
Induction success
Description
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)
Time Frame
Days 0 through 7
Title
Treatment adherence
Description
defined as percent of urine drug screens positive for buprenorphine throughout pregnancy
Time Frame
Days 0 through delivery
Title
Recovery success
Description
defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care
Time Frame
Days 0 through delivery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassandra J Trammel, MD, MBA
Phone
314-121-1129
Email
cjtrammel@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannie C Kelly, MD, MS
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeannie Kelly, MD
Email
jckelly@wustl.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

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