CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
Clonidine +1 moredrug
Likely dose
Clonidine 1mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03396588
NCT03396588Phase 3Completed
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Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain

Henrietta Bada·interventional·Posted Jan 11, 2018·Updated May 23, 2025

In Brief

A Phase 3 clinical trial evaluating Clonidine and Morphine for Neonatal Abstinence Syndrome. Completed, enrolled 120 participants across 1 site.

Detailed Summary

The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes. The objective of this application is to evaluate the effectiveness of clonidine as a treatment for neonates with NAS, in a randomized clinical trial. Our central hypothesis is that clonidine will effectively treat drug withdrawal manifestations in neonates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Abstinence Syndrome
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 11, 2018
Enrollment StartDec 7, 2017
Primary CompletionApr 10, 2024
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 8.5 years ago

Interventions

Clonidinedrug

1mcg/kg/dose (with a dosing interval of 3 or 4 hours), increases by 25% of initial dose every 12-24 hrs. Decrease by 10% of max dose every 24 hrs.

Morphinedrug

Starting dose is 0.06 mg/kg/dose (every 3 or 4 hours), increases by 25% of initial dose every 12-24 hrs. Decrease by 10% of max dose every 24 hrs.