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NCT Number: NCT05790252

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

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.

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Key information

Conditions

Opioid Use Disorder Buprenorphine Withdrawal Chemically-Induced Disorders Female Urogenital Diseases and Pregnancy Complications Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Pregnancy Complications Pregnancy Related Pregnancy, High Risk Substance-Related Disorders Urogenital Diseases

Age range

18 year–110 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Washington University in St. Louis

St Louis, Missouri, 63124, United States

Location status: Recruiting

Location contact

Jeannie Kelly, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Induction withdrawal severity

    Time frame: Days 0 through 4

    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+.

Secondary outcomes

  1. Induction success

    Time frame: Days 0 through 7

    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)

  2. Treatment adherence

    Time frame: Days 0 through delivery

    defined as percent of urine drug screens positive for buprenorphine throughout pregnancy

  3. Recovery success

    Time frame: Days 0 through delivery

    defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care

Study contacts

Contact information is provided by the study sponsor or research team.

Cassandra J Trammel, MD, MBA

CONTACT

[email protected]

314-121-1129

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: Patch BRIDGE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2023
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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