Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Between 18 Years and 110 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University in St. Louis
St Louis 4407066, Missouri 4398678 63124
Contact:
Jeannie Kelly, MD
jckelly@wustl.edu

More Details

NCT ID
NCT05790252
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

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