← Back to Search

Alpha-2 Adrenergic Agonist

Clonidine vs Morphine for Neonatal Abstinence Syndrome

Phase 4
Waitlist Available
Led By Alla Kushnir, MD
Research Sponsored by The Cooper Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No congenital anomalies or neurologic condition (i.e. hypoxic-ischemic encephalopathy, seizures, meningitis etc.)
Greater than or equal to 35 weeks gestation age
Must not have
Blood pressure instability
Premature infants less than 35 week gestational age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 18-24 months corrected gestational age
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will compare the effects of Clonidine to those of Morphine in Neonatal Abstinence Syndrome.

Who is the study for?
This trial is for newborns born at Cooper University Hospital, who are at least 35 weeks gestational age and show withdrawal symptoms from substances their mothers used during pregnancy. These babies should not have congenital anomalies or major medical conditions like blood pressure instability.
What is being tested?
The study compares Clonidine with Morphine Sulfate to see if Clonidine can shorten the hospital stay and treatment duration for Neonatal Abstinence Syndrome (NAS), which affects babies withdrawing from exposure to drugs in the womb.
What are the potential side effects?
Clonidine may cause low blood pressure, slow heart rate, drowsiness, or dry mouth. Morphine's side effects include respiratory depression, constipation, sedation, and potential dependency issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have any birth defects or brain conditions.
Select...
I am at least 35 weeks into my pregnancy.
Select...
My baby is in the NICU or Transitional nursery.
Select...
My baby is starting medication for withdrawal symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My blood pressure frequently changes.
Select...
My baby was born before 35 weeks of pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 18-24 months corrected gestational age
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 18-24 months corrected gestational age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Length of treatment
Secondary study objectives
Length of stay
Other study objectives
Cognitive development

Side effects data

From 2009 Phase 4 trial • 12 Patients • NCT00370838
50%
Tired/sleepy
40%
Anxious
30%
Fatigue
30%
Aggression
20%
Stomache ache
20%
Lethargic
20%
Insomnia
20%
Irritability
10%
Dry mouth
10%
Dizzy
10%
Sleepwalking
10%
Sad/depressed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clonidine
Levetiracetam

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ClonidineExperimental Treatment1 Intervention
Clonidine at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours
Group II: MorphineActive Control1 Intervention
Morphine Sulfate at 0.03 mg/kg/dose every 3 hours or 0.04 mg/kg/dose every 4 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clonidine
2010
Completed Phase 4
~1890

Find a Location

Who is running the clinical trial?

The Cooper Health SystemLead Sponsor
81 Previous Clinical Trials
35,558 Total Patients Enrolled
Alla Kushnir, MD5.01 ReviewsPrincipal Investigator - The Cooper Health System
The Cooper Health System
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Clonidine (Alpha-2 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03092011 — Phase 4
Neonatal Abstinence Syndrome Research Study Groups: Clonidine, Morphine
Neonatal Abstinence Syndrome Clinical Trial 2023: Clonidine Highlights & Side Effects. Trial Name: NCT03092011 — Phase 4
Clonidine (Alpha-2 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03092011 — Phase 4
~9 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top