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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
Must not have
Seizures
Blood pressure instability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years of life
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Pivotal 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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have seizures.
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My blood pressure frequently changes.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bayley Scales of Infant and Toddler Development Third Edition
Neurobehavioral Performance Summary Scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
Secondary study objectives
Duration of treatment

Awards & Highlights

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 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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).

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
2,568 Previous Clinical Trials
3,285,540 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
~6 spots leftby Mar 2025
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