Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Pregnancy Related Clinical Trial

— Patch BRIDGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05790252
• Other study ID #: 202209093
• Status: Recruiting
• Phase: Phase 3
• Start date: June 26, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Washington University School of Medicine
• Contact: Cassandra J Trammel, MD, MBA
• Phone: 314-121-1129
• Email: cjtrammel[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Pregnancy Complications
• Pregnancy Related
• Pregnancy, High Risk

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Treatment adherence	defined as percent of urine drug screens positive for buprenorphine throughout pregnancy	Days 0 through delivery
Secondary	Recovery success	defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care	Days 0 through delivery