Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-110
SponsorWashington University School of Medicine

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 volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Buprenorphine Transdermal Matrix Patch

    Drug

    Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.

  • Sham patch

    Other intervention

    Bandage applied at time of induction initiation and removed at 48 hours.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Bridge Induction ArmExperimental treatment 1 intervention
Group B: Standard ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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+.

Time frame
Days 0 through 4

Secondary outcomes

1

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)

Time frame
Days 0 through 7
2

Treatment adherence

defined as percent of urine drug screens positive for buprenorphine throughout pregnancy

Time frame
Days 0 through delivery
3

Recovery success

defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care

Time frame
Days 0 through delivery

Other outcomes

Sponsors and contacts

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