Patch BRIDGE: Buprenorphine Induction During Pregnancy

This study is testing a buprenorphine transdermal matrix patch to help pregnant patients with opioid use disorder start buprenorphine treatment. Normally, patients need to be in withdrawal before starting buprenorphine by mouth. This study wants to see if the patch can reduce withdrawal symptoms and lead to more successful treatment. You might be able to join if you are pregnant, have opioid use disorder, receive prenatal care at the institution's clinic, have used opioids within 24 hours, and want buprenorphine treatment. The study aims to enroll 40 women.

Study design
This interventional study plans to enroll 40 women to compare a buprenorphine patch to a sham patch.
What's involved
Participants will have either a buprenorphine patch or a sham patch applied at the start of treatment and removed after 48 hours.
Compensation
Not stated in the trial record.
Follow-up
Withdrawal severity will be measured daily from Day 0 through Day 4.

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NCT05790252

Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Washington University School of Medicine
~40 participants
Updated 2025-10-14 on ClinicalTrials.gov
What's tested:Buprenorphine Transdermal Matrix PatchSham patch

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Induction withdrawal severity
Measured over Days 0 through 4
Opioid Use Disorder
Pregnancy Related
Pregnancy, High Risk
Pregnancy Complications
Buprenorphine Withdrawal
1 sites across 1 states
Missouri1
  • Jeannie C Kelly, MD, MS · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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Eligibility criteria

Inclusion

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

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
  • Induction withdrawal severityDays 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+.