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Opioid Partial Agonist

Sublingual Buprenorphine for Neonatal Abstinence Syndrome

Q: How many people are helping to test this new medical treatment?

Unfortunately, this trial is no longer recruiting patients. The study was originally posted on October 1st, 2014 but the most recent edit was on May 4th, 2016. There are presently 36 clinical trials actively admitting participants with passive <a href="https://www.withpower.com/clinical-trials/addiction">addiction</a> and 60 trials for BZDs + opiate exposure treated with BPN that are still looking for candidates.

Q: What do BZDs + opiate exposure patients usually take BPN for?

BZDs + opiate exposure treated with BPN is not only an effective treatment for opioids, but also useful in treating other conditions like pruritus, <a href="https://www.withpower.com/clinical-trials/pain">pain</a>, and septic shock.

Q: Are there other scientific research trials that have looked at the effects of BZDs + opiate exposure treated with BPN?

60 medical studies are currently underway that involve the exposure of BZDs and opiates to BPN. Of these, 14 are in Phase 3. The majority of locations conducting these trials are in White River Junction, <a href="https://www.withpower.com/clinical-trials/vermont">Vermont</a>; however, there are a total of 243 sites running clinical trials for this specific intervention.

Q: Are patients currently being sought for this clinical trial?

The clinical trial in question is not currently active, according to the website clinicaltrials.gov. This particular study was posted on October 1st, 2014 but has not seen any new updates since May 4th, 2016. Although this specific trial isn't looking for candidates, there are 96 other trials with open recruitment at this time.

Phase 1 & 2

Waitlist Available

Led By Estelle B Gauda, MD

Research Sponsored by Gauda, Estelle B., M.D.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newborns ≥ 35 0/7 wks. Gestation undelivered or < 12 hours of age at enrollment and within the 72 hrs. after birth at the time of transfer to ACH for pharmacologic treatment for moderate to severe NAS

Newborns ≥ 2 kg weight at birth (10th % for a 35 0/7 wk. newborn)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-8 weeks

Awards & highlights

Study Summary

This trial is studying whether buprenorphine is safe and effective in treating NAS in infants whose mothers are dependent on both opioids and benzodiazepines.

Who is the study for?

This trial is for newborns who are at least 35 weeks old, weigh over 2 kg, and show moderate to severe withdrawal symptoms from maternal drug use. They must be enrolled within the first 72 hours after birth. Infants with serious illnesses, on antibiotics for more than three days, or have received non-study drugs to treat their condition can't participate.Check my eligibility

What is being tested?

The study tests buprenorphine's effectiveness in treating withdrawal symptoms in infants exposed to opiates and benzodiazepines during pregnancy. It aims to determine if it's safe for those also exposed to benzodiazepines compared to just opiates.See study design

What are the potential side effects?

Potential side effects of buprenorphine treatment may include respiratory depression or other adverse events; however, the study anticipates that it will be safe for infants with opiate and benzodiazepine exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My newborn is over 35 weeks gestation, less than 12 hours old, and needs treatment for NAS.

Select...

My newborn weighed at least 2 kg at birth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assessment of vital signs

Secondary outcome measures

To determine BNP levels in blood, urine, and meconium(stool)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BZDs + opiate exposure treated with BPNExperimental Treatment1 Intervention

In-utero opiate and BZD exposed neonates + Buprenorphine sub-lingual administered in dose volumes greater than 0.5 mL will be given in 2 aliquots separated by 2 minutes allowing time for the drug to be absorbed.

Group II: Opiates exposure treated with BPNActive Control1 Intervention

In-utero opiate exposed neonates + Buprenorphine sub-lingual administered in dose volumes greater than 0.5 mL will be given in 2 aliquots separated by 2 minutes allowing time for the drug to be absorbed.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gauda, Estelle B., M.D.Lead Sponsor

Johns Hopkins UniversityOTHER

2,256 Previous Clinical Trials

14,820,031 Total Patients Enrolled

Johns Hopkins All Children's HospitalOTHER

43 Previous Clinical Trials

5,007,499 Total Patients Enrolled

Media Library

BPN (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02249026 — Phase 1 & 2

Neonatal Drug Withdrawal Research Study Groups: BZDs + opiate exposure treated with BPN, Opiates exposure treated with BPN

Neonatal Drug Withdrawal Clinical Trial 2023: BPN Highlights & Side Effects. Trial Name: NCT02249026 — Phase 1 & 2

BPN (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02249026 — Phase 1 & 2

Frequently Asked Questions

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

How many people are helping to test this new medical treatment?

"Unfortunately, this trial is no longer recruiting patients. The study was originally posted on October 1st, 2014 but the most recent edit was on May 4th, 2016. There are presently 36 clinical trials actively admitting participants with passive addiction and 60 trials for BZDs + opiate exposure treated with BPN that are still looking for candidates."

Answered by AI

What do BZDs + opiate exposure patients usually take BPN for?

"BZDs + opiate exposure treated with BPN is not only an effective treatment for opioids, but also useful in treating other conditions like pruritus, pain, and septic shock."

Answered by AI

Are there other scientific research trials that have looked at the effects of BZDs + opiate exposure treated with BPN?

"60 medical studies are currently underway that involve the exposure of BZDs and opiates to BPN. Of these, 14 are in Phase 3. The majority of locations conducting these trials are in White River Junction, Vermont; however, there are a total of 243 sites running clinical trials for this specific intervention."

Answered by AI

Are patients currently being sought for this clinical trial?

"The clinical trial in question is not currently active, according to the website clinicaltrials.gov. This particular study was posted on October 1st, 2014 but has not seen any new updates since May 4th, 2016. Although this specific trial isn't looking for candidates, there are 96 other trials with open recruitment at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sublingual Buprenorphine Treatment for Neonatal Abstinence Syndrome - Pilot Study

2014. "Sublingual Buprenorphine Treatment for Neonatal Abstinence Syndrome - Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02249026.

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