Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

NCT05790252 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 202209093
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Induction success

  Days 0 through 7

• Treatment adherence

  Days 0 through delivery

• Recovery success

  Days 0 through delivery

Study Arms (2)

Bridge Induction Arm

EXPERIMENTAL

Drug: Buprenorphine Transdermal Matrix Patch

Standard Arm

PLACEBO COMPARATOR

Other: Sham patch

Interventions

Buprenorphine Transdermal Matrix Patch DRUG

Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.

Bridge Induction Arm

Sham patch OTHER

Bandage applied at time of induction initiation and removed at 48 hours.

Standard Arm

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63124, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Pregnancy Complications

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jeannie C Kelly, MD, MS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra J Trammel, MD, MBA

CONTACT

314-121-1129; cjtrammel@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 30, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)