Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05790252
Status:
RECRUITING
Last Update Posted:
2023-07-25
First Post:
2023-03-13
Brief Title:
Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy Patch BRIDGE
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy A Randomized Controlled Trial The Patch BRIDGE Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Patch BRIDGE
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None