About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Buprenorphine Transdermal Matrix Patch
  • Sham patch

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

1
Washington University in St. Louis63124, St LouisMissouri, United States

Sponsors and collaborators

Washington University School of Medicine

Lead sponsor