RECRUITING

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-27
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05790252

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 110 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Viable pregnancy
  2. * Meet diagnostic criteria for opioid use disorder
  3. * Receive prenatal care through opioid use disorder specific clinic at our institution
  4. * Opioid use within 24 hours prior to presentation
  5. * Desire treatment with buprenorphine
  1. * Patients already receiving treatment for opioid use disorder
  2. * History of prior induction attempt with buprenorphine
  3. * Active withdrawal at time of presentation
  4. * Medical contraindication to buprenorphine
  5. * Requiring immediate hospitalization

Contacts and Locations

Study Contact

Cassandra J Trammel, MD, MBA
CONTACT
314-121-1129
cjtrammel@wustl.edu

Principal Investigator

Jeannie C Kelly, MD, MS
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University in St. Louis
Saint Louis, Missouri, 63124
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Jeannie C Kelly, MD, MS, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2023-11-27
Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

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