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NCT05790252 · ClinicalTrials.gov registry record · Phase 3
Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)
A Phase 3 study of Opioid Use Disorder and Pregnancy Related, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05790252: Recruiting Phase 3 study of Opioid Use Disorder and Pregnancy Related, sponsored by Washington University School of Medicine.
NCT05790252 is a Phase 3 study of Opioid Use Disorder and Pregnancy Related that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 40 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05790252, a Phase 3 study of Opioid Use Disorder and Pregnancy Related, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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+.
Conditions Studied
Interventions
- DRUG Buprenorphine Transdermal Matrix Patch
- OTHER Sham patch
Study Locations (1)
Missouri
- Washington University in St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-11-27 |
| Est. Completion | 2026-12-01 |
| Phase | Phase 3 |
What NCT05790252 shows while recruiting
NCT05790252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Buprenorphine Transdermal Matrix Patch is the first listed.
NCT05790252 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05790252 about?
NCT05790252 is a clinical study titled "Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)". 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 withd...
What is the current status of trial NCT05790252?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2023-11-27. Estimated completion is 2026-12-01.
What conditions does trial NCT05790252 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk, Buprenorphine Withdrawal.
What interventions are being tested in trial NCT05790252?
The interventions under investigation include: Buprenorphine Transdermal Matrix Patch (DRUG), Sham patch (OTHER).
Who is sponsoring clinical trial NCT05790252?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05790252 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05790252's enrollment target sits among peer trials
40 183rd of 257 higher than 67 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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