• Child's head circumference measurement (measured at birth) [ Time Frame: birth ] [ Designated as safety issue: Yes ]
  
• Child's length of hospital stay [ Time Frame: delivery until hospital d/c ] [ Designated as safety issue: Yes ]
  
• Number of children requiring treatment for Neonatal Abstinence Signs (NAS) [ Time Frame: from birth until no treatment ] [ Designated as safety issue: Yes ]
  
• Child's peak daily total NAS score [ Time Frame: from birth until NS no longer measured ] [ Designated as safety issue: Yes ]
  
• Total amount of withdrawal medication child receives [ Time Frame: from start of NAS treatment until discontinuation of NAS treatment ] [ Designated as safety issue: Yes ]
  

• Mother's self-report of drug use (measured monthly by Time Line Follow Back) [ Time Frame: course of study participations ] [ Designated as safety issue: No ]
  
• Mother's HIV risk behaviors (measured monthly by Risk Behavior Assessment) [ Time Frame: from start to end of study participation ] [ Designated as safety issue: Yes ]
  
• Mother's measures of dose adequacy and acceptance over time (measured weekly by Dose Adequacy Questionnaire) [ Time Frame: from start to end of study participation ] [ Designated as safety issue: No ]
  
• Mother's psychosocial functioning (measured monthly by Addiction Severity Index and SCID) [ Time Frame: measured at intake and monthly during study participation ] [ Designated as safety issue: No ]
  

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 behavioral problems. Methadone, a synthetic narcotic, is commonly prescribed to treat opioid addiction. It may not be an optimal solution for opioid-dependent pregnant women, however, because a large percentage of children born to women taking methadone experience severe drug withdrawal symptoms at birth that often require medical treatment. Common opioid withdrawal symptoms, described as neonatal abstinence syndrome (NAS) in babies, include tremors, irritability, sleep problems, seizures, dehydration, and fever. Buprenorphine is a medication that has been approved to treat opioid dependence in individuals who are not pregnant but has not been approved for pregnant individuals. Past research has shown that use of buprenorphine in pregnant women results in improved birth outcomes over methadone. The purpose of this study is to evaluate the effectiveness of buprenorphine versus methadone at reducing opioid withdrawal symptoms in babies born to opioid-dependent women.

This study will enroll opioid-dependent pregnant women who are 13 to 30 weeks pregnant and will follow each woman and her child throughout the pregnancy until 6 weeks postpartum. All participants will undergo an initial screening that will last several hours. Participants will then be randomly assigned to receive either methadone or buprenorphine on a daily basis, and will be required to visit the clinic each day to receive their medication. Outcome measurements will be assessed at weekly study visits throughout the pregnancy, and will include drug use, HIV risk behaviors, medication dose adequacy and safety, treatment retention, and psychosocial functioning. Urine samples will be collected 3 times a week, and blood will be drawn throughout the pregnancy for safety monitoring. Outcome measurements related to the baby will include head circumference measurement, length of hospital stay, severity and frequency of withdrawal symptoms, and amount of medication needed to control withdrawal symptoms.