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Opioid Partial Agonist

Buprenorphine Patch for Opioid Addiction in Pregnancy (Patch BRIDGE Trial)

Phase 3
Recruiting
Led By Jeannie C Kelly, MD, MS
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0 through 7
Awards & highlights
Pivotal Trial

Summary

This trial will compare two ways of starting buprenorphine treatment for pregnant patients with opioid use disorder, to see which is safer and more effective.

Who is the study for?
This trial is for pregnant individuals who have opioid use disorder and want to start buprenorphine treatment. They must have used opioids within the last 24 hours, be receiving prenatal care at a specific clinic, and not have tried buprenorphine induction before or need immediate hospitalization.
What is being tested?
The study tests if a buprenorphine patch can help manage withdrawal symptoms better than no patch during the period before starting sublingual buprenorphine. Success of the treatment will be monitored through daily phone surveys and urine drug screens at prenatal visits.
What are the potential side effects?
Possible side effects include skin irritation where the patch is applied, typical opioid withdrawal symptoms such as nausea, vomiting, muscle aches, fever, and potential risks associated with any form of medication-assisted therapy during pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0 through 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0 through 7 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Induction withdrawal severity
Secondary study objectives
Induction success
Recovery success
Treatment adherence

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bridge Induction ArmExperimental Treatment1 Intervention
Group II: Standard ArmPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,825 Total Patients Enrolled
Jeannie C Kelly, MD, MSPrincipal InvestigatorWashington University School of Medicine

Media Library

Buprenorphine Transdermal Matrix Patch (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05790252 — Phase 3
Pregnancy Research Study Groups: Bridge Induction Arm, Standard Arm
Pregnancy Clinical Trial 2023: Buprenorphine Transdermal Matrix Patch Highlights & Side Effects. Trial Name: NCT05790252 — Phase 3
Buprenorphine Transdermal Matrix Patch (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05790252 — Phase 3
~20 spots leftby Dec 2025
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