Trials / Recruiting
RecruitingNCT05790252
Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)
Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- Female
- Age
- 18 Years – 110 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Opioid Use Disorder
- Pregnancy Related
- Pregnancy, High Risk
- Pregnancy Complications
- Buprenorphine Withdrawal
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Buprenorphine Transdermal Matrix Patch | Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours. |
| OTHER | Sham patch | Bandage applied at time of induction initiation and removed at 48 hours. |
Timeline
- Start date
- 2023-11-27
- Primary completion
- 2026-07-01
- Completion
- 2026-12-01
- First posted
- 2023-03-30
- Last updated
- 2025-10-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05790252. Inclusion in this directory is not an endorsement.