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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 0 through 7

Awards & highlights

Patch BRIDGE 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.Check my eligibility

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.See study design

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.

Patch BRIDGE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 0 through 7

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Induction withdrawal severity

Secondary outcome measures

Induction success

Recovery success

Treatment adherence

Patch BRIDGE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bridge Induction ArmExperimental Treatment1 Intervention

Group II: Standard ArmPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,937 Previous Clinical Trials

2,299,655 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available in this experiment?

"As per information found on clinicaltrials.gov, this experiment is currently recruiting participants. Initially posted on June 26th 2023 and most recently edited on July 24th of the same year."

Answered by AI

What is the overall participant count of this investigation?

"Affirmative. Data published on clinicaltrials.gov confirms that the enrollment process for this medical trial is ongoing, having begun on June 26th 2023 and later updated on July 24th 2023. The study requires 40 participants from 1 singular site."

Answered by AI