CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 175 enrolled
Drug / intervention
Methadone +1 moredrug
Likely dose
Methadone 140 mgfrom 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/NCT00271219
NCT00271219Phase 3Completed
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Maternal Opioid Treatment: Human Experimental Research

Johns Hopkins University·interventional·Posted Dec 30, 2005·Updated Aug 5, 2015

In Brief

A Phase 3 clinical trial evaluating Methadone and Buprenorphine for Opioid Related Disorders and 2 related conditions. Completed, enrolled 175 participants across 8 sites in 3 countries.

Detailed Summary

Children born to women who abuse drugs have a high risk of being born with birth defects and developmental problems. Methadone is a drug that is commonly used for treating opioid dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a newborn because of the prenatal exposure. The purpose of this study is to evaluate the effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal symptoms in children born to opioid-dependent women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Related Disorders, Pregnancy, Opioid Dependence
CountriesAustria, Canada, United States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 30, 2005
Enrollment StartJul 1, 2005
Primary CompletionAug 1, 2009
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.5 years ago

Interventions

Methadonedrug

daily oral dosing 20-140 mg

Buprenorphinedrug

sl daily 2-32 mg