NCT05790252 Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)
| NCT ID | NCT05790252 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Washington University School of Medicine |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2023-11-27 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Jeannie C Kelly, MD, MS
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT05790252 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 110 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05790252 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT05790252 currently recruiting?
Yes, NCT05790252 is actively recruiting participants. Contact the research team at cjtrammel@wustl.edu for enrollment information.
Where is the NCT05790252 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT05790252 clinical trial?
NCT05790252 is sponsored by Washington University School of Medicine. The principal investigator is Jeannie C Kelly, MD, MS at Washington University School of Medicine. The trial plans to enroll 40 participants.