CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Methadone +1 moredrug
Likely dose
Methadone 1mgfrom 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/NCT01723722
NCT01723722Phase 4Completed
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Treatment of Neonatal Abstinence Syndrome: Evaluation of Efficacy of Phenobarbital in Combination With Either Methadone or Diluted Deodorized Tincture of Opium as Stabilizing and Tapering Regiments

Eastern Maine Medical Center·interventional·Posted Nov 8, 2012·Updated Nov 27, 2013

In Brief

A Phase 4 clinical trial evaluating Methadone and Diluted Deodorized Tincture of Opium for Neonatal Abstinence Syndrome. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment. This is a randomized, open-label comparison of phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Abstinence Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 8, 2012
Enrollment StartJan 1, 2007
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.7 years ago

Interventions

Methadonedrug

Concentration is 1mg/mL administered every 12 hours given on sliding scale in response to last NAS score.

Diluted Deodorized Tincture of Opiumdrug

Concentration is 1:24 dilution for a concentration of 0.4%