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
Locations
1Sponsors and collaborators
Washington University School of Medicine
Lead sponsor