RCT Comparing Methadone and Buprenorphine in Pregnant Women
Completed · Phase 3
Conditions studied: Opioid Related Disorders, Pregnancy, Opioid Dependence
In brief
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.
Key facts
- Study ID
- NCT00271219
- Run by
- Johns Hopkins University
- People needed
- 175
- Starts
- 2005-07-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2015-08-05
Who can join
Age: 18 and older, up to 41. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Current opioid dependence
- Current opioid use, as determined by a urine drug test
- Pregnant with a single child with a gestational age of 6 to 30 weeks, as determined by a sonogram
You may not qualify if…
- Current medical condition that would make study participation dangerous, as determined by study physician
- Diagnosed with an acute, severe psychiatric illness
- Current SCID I-E module diagnosis of benzodiazepine or alcohol abuse
- Use of alcohol or benzodiazepines in the 30 days prior to study entry, as determined by the Addiction Severity Index
- Pending legal action that may prohibit or interfere with study participation
Where it is running
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
- Wayne State University — Detroit, Michigan, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Brown University — Providence, Rhode Island, United States
- Vanderbilt University — Nashville, Tennessee, United States
- University of Vermont — Burlington, Vermont, United States
- Medical University of Vienna — Vienna, Austria
- St. Joseph's Health Centre — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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