Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

The Washington University

Status and phase: Enrolling; Phase 3

Conditions: Buprenorphine Withdrawal; Pregnancy Complications; Opioid Use Disorder; Pregnancy Related; Pregnancy, High Risk

Treatments: Other: Sham patch; Drug: Buprenorphine Transdermal Matrix Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT05790252

202209093

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Bridge Induction Arm

Experimental group

Treatment:

Drug: Buprenorphine Transdermal Matrix Patch

Standard Arm

Placebo Comparator group

Treatment:

Other: Sham patch