Status:
COMPLETED
RCT Comparing Methadone and Buprenorphine in Pregnant Women
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Related Disorders
Pregnancy
Eligibility:
FEMALE
18-41 years
Phase:
PHASE3
Brief 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, ...
Detailed Description
Women who use drugs during pregnancy place their unborn children at high risk for being born addicted to drugs. Such children may also be born with birth defects and may experience learning and behavi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00271219
Start Date
July 1 2005
End Date
June 1 2010
Last Update
August 5 2015
Active Locations (8)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
2
Wayne State University
Detroit, Michigan, United States, 48207
3
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
4
Brown University
Providence, Rhode Island, United States, 02912