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Opioid Partial Agonist
Sublingual Buprenorphine for Neonatal Abstinence Syndrome
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)
Must not have
Infants requiring drug therapy with any high or moderate CYP3A4 inhibitor or inducer (Appendix A)
Any illness that precludes oral or sublingual medication use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-8 weeks
Awards & highlights
Summary
This study is evaluating whether buprenorphine is safe in infants born to mothers with co-dependence on an opiate and a benzodiazepine.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My infant is not on any strong or moderate drugs that affect enzyme levels.
Select...
I cannot take medications by mouth or under the tongue.
Select...
My infant needs medication to manage severe pain, such as from a fracture.
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My infant has not received any treatment for NAS other than the study drug.
Select...
My newborn is either less than 35 weeks old or was transferred for treatment after 72 hours of life.
Select...
I have a serious illness or have been on antibiotics for more than 3 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2-8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-8 weeks
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.
Find a Location
Who is running the clinical trial?
Gauda, Estelle B., M.D.Lead Sponsor
Johns Hopkins UniversityOTHER
2,285 Previous Clinical Trials
14,843,025 Total Patients Enrolled
Johns Hopkins All Children's HospitalOTHER
43 Previous Clinical Trials
5,007,499 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My newborn is over 35 weeks gestation, less than 12 hours old, and needs treatment for NAS.My newborn weighed at least 2 kg at birth.You are currently breastfeeding your baby.You were born with serious birth defects.My infant is not on any strong or moderate drugs that affect enzyme levels.I cannot take medications by mouth or under the tongue.My infant needs medication to manage severe pain, such as from a fracture.My infant has not received any treatment for NAS other than the study drug.My newborn is either less than 35 weeks old or was transferred for treatment after 72 hours of life.I have a serious illness or have been on antibiotics for more than 3 days.
Research Study Groups:
This trial has the following groups:- Group 1: BZDs + opiate exposure treated with BPN
- Group 2: Opiates exposure treated with BPN
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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