RCT Comparing Methadone and Buprenorphine in Pregnant Women

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Buprenorphine; Methadone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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