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Alpha-2 Adrenergic Agonist

Clonidine for Neonatal Abstinence Syndrome (No-POPPY Trial)

Phase 3

Waitlist Available

Led By Henrietta S Bada, MD MPH

Research Sponsored by Henrietta Bada

Eligibility Criteria Checklist

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

Must have

No morphine or clonidine dose before enrollment

Symptomatic with Finnegan scores (FS): 3 consecutive scores greater than or equal to 8, OR 2 consecutive scores greater than or equal to 12, and/or with attending decision to treat for NAS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years of life

Awards & highlights

No-POPPY Trial Summary

This trial is testing whether clonidine is an effective treatment for drug withdrawal in neonates. The hypothesis is that it will be effective.

Who is the study for?

This trial is for newborns up to 7 days old with Neonatal Abstinence Syndrome (NAS) due to prenatal opiate exposure. They must have specific withdrawal scores, no prior treatment with morphine or clonidine, and be born at a gestational age of 35 weeks or more. Babies exposed to cocaine prenatally, those with seizures, major malformations, blood pressure issues, or other serious medical conditions are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of clonidine compared to morphine in treating NAS symptoms in newborns. It's a randomized trial which means babies will be randomly assigned to receive either clonidine or morphine as part of their treatment plan.See study design

What are the potential side effects?

Possible side effects from clonidine may include low blood pressure, slow heart rate, drowsiness, and dry mouth. Morphine can cause slowed breathing rates, constipation, nausea and potential dependency issues.

No-POPPY Trial Eligibility Criteria

Inclusion Criteria

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

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I have not taken morphine or clonidine before joining.

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My baby has high Finnegan scores indicating they might need treatment for NAS.

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I am 7 days old or younger.

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I was exposed to opiates before birth.

No-POPPY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years of life

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years of life

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years of life for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Bayley Scales of Infant and Toddler Development Third Edition

Neurobehavioral Performance Summary Scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)

Secondary outcome measures

Duration of treatment

No-POPPY Trial Design

2Treatment groups

Active Control

Group I: ClonidineActive Control1 Intervention

Babies randomized to clonidine will receive 1mcg/kg/dose (with a dosing interval of 3 or 4 hours).

Group II: MorphineActive Control1 Intervention

Babies randomized to morphine will receive 0.06 mg/kg/dose (with a dosing interval of 3 or 4 hours).

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Henrietta BadaLead Sponsor

1 Previous Clinical Trials

31 Total Patients Enrolled

1 Trials studying Neonatal Abstinence Syndrome

31 Patients Enrolled for Neonatal Abstinence Syndrome

National Institute on Drug Abuse (NIDA)NIH

2,465 Previous Clinical Trials

2,618,513 Total Patients Enrolled

13 Trials studying Neonatal Abstinence Syndrome

1,178 Patients Enrolled for Neonatal Abstinence Syndrome

Henrietta S Bada, MD MPHPrincipal InvestigatorUniversity of Kentucky

Media Library

Clonidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03396588 — Phase 3

Neonatal Abstinence Syndrome Research Study Groups: Clonidine, Morphine

Neonatal Abstinence Syndrome Clinical Trial 2023: Clonidine Highlights & Side Effects. Trial Name: NCT03396588 — Phase 3

Clonidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03396588 — Phase 3

Frequently Asked Questions

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

What are the eligibility requirements to participate in this research?

"The requirements to take part in this clinical trial are that the participants must have neonatal abstinence syndrome, be between 12 hours and 7 days old, and have a passive addiction. Out of 200 total potential candidates, this many people fit the bill."

Answered by AI

How many people will be included in this trial at most?

"That is correct. The clinical trial is currently open and recruiting patients. According to the information available on clinicaltrials.gov, the trial was originally posted on December 7th, 2017 and last updated on July 27th, 2022. Up to 200 participants are needed at a single location."

Answered by AI

Does Clonidine put patients at risk for any adverse health effects?

"Clonidine's safety is well-documented, as this medication has been through Phase 3 trials. This means that there is data supporting both its efficacy and safety."

Answered by AI

For what conditions is Clonidine commonly prescribed?

"Clonidine is usually given to patients suffering from diabetic diarrhea. That said, it can also help those going through menopause, struggling with ADHD, and dealing with pheochromocytomas."

Answered by AI

What other medical studies have used Clonidine as a trial drug?

"Currently, there are 82 clinical trials for Clonidine with 22 of them in Phase 3. Many of these trials are based out of Boston, but there are a total of 212 research sites conducting these studies."

Answered by AI

Does this experiment only require participants who are 18 or older?

"According to the study's inclusion criteria, patients that fall between 12 hours and 7 days old are eligible for this trial. Out of the 93 total participants, 30 will be children and 63 will be adults over the age of 65."

Answered by AI

How can interested parties sign up for this experiment?

"That is correct, the clinical trial is still recruiting patients. According to the information on clinicaltrials.gov, the study was posted on December 7th, 2017 and updated on July 27th, 2020. They are looking for 200 patients at 1 site."

Answered by AI

Recent research and studies

PediatricsJournal

Morphine Versus Clonidine for Neonatal Abstinence Syndrome

Bada, Henrietta S., Thitinart Sithisarn, Julia Gibson, Karen Garlitz, Rhonda Caldwell, Gilson Capilouto, Yinglei Li, Markos Leggas, and Patrick Breheny. 2015. “Morphine Versus Clonidine for Neonatal Abstinence Syndrome”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2014-2377.

PediatricsJournal

Morphine Versus Clonidine for Neonatal Abstinence Syndrome

clinicaltrials.govStudy

Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain

Henrietta Bada 2017. "Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03396588.