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RCT Comparing Methadone and Buprenorphine in Pregnant Women

NCT00271219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2015-08-05

Study results available
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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.

Conditions

  • Opioid Related Disorders
  • Pregnancy
  • Opioid Dependence

Interventions

DRUG

Methadone

daily oral dosing 20-140 mg

DRUG

Buprenorphine

sl daily 2-32 mg

Sponsors & Collaborators

Principal Investigators

  • Hendree E. Jones, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2009-08-31
Completion
2010-06-30

Countries

  • United States
  • Austria
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00271219 on ClinicalTrials.gov