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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Buprenorphine Transdermal Matrix Patch
DrugBuprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.
Sham patch
Other interventionBandage applied at time of induction initiation and removed at 48 hours.
Treatment groups
Trial outcomes
Primary outcomes
Induction withdrawal severity
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
Induction success
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)
Treatment adherence
defined as percent of urine drug screens positive for buprenorphine throughout pregnancy
Recovery success
defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care
Sponsors and contacts
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