Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05790252
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • Buprenorphine Transdermal Matrix Patch — DRUG
    Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.
  • Sham patch — OTHER
    Bandage applied at time of induction initiation and removed at 48 hours.

Study Details

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.

Key Dates

Start date
Nov 27, 2023
Status verified
Oct 2025
Primary completion
Jul 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bridge Induction Arm
  • Placebo Comparator: Standard Arm

Primary Outcome Measure

Induction withdrawal severity [ Time Frame: Days 0 through 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in St. LouisSt LouisMissouri63124
Jeannie Kelly, MD
[email protected]

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