Fetal and Infant Effects of Maternal Buprenorphine Treatment
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This research will track the longitudinal neurobehavioral development of the
      buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine
      the safety of this medication for use during gestation, the relationship between maternal
      physiologic changes due to buprenorphine administration and newborn functioning, and to
      determine potential fetal neurobehavioral markers that may predict Neonatal Abstinence
      Syndrome expression and infant neurobehavioral outcome. Comparisons to results from a similar
      project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way
      the investigators inform the treatment of the opioid dependent woman during pregnancy and her
      infant after birth.
    

Detailed description: 
      There is an increase in the prevalence of illicit opiate use among women of childbearing age
      in many countries today. Methadone is the treatment of choice for opioid dependency during
      pregnancy in the US because it markedly diminishes withdrawal symptoms and craving and blocks
      opioid effects, however, in utero exposure results in significant depression of fetal
      neurobehaviors such as fetal heart rate and heart rate variability and fetal motor activity,
      and significant neonatal abstinence syndrome (NAS) in the majority of exposed infants. Since
      its approval in 2002, the prescription of buprenorphine for opioid dependence has increased
      dramatically but, as with methadone, this mediation is not approved for use during pregnancy.
      Currently, women treated with buprenorphine prior to pregnancy are transitioned to methadone
      treatment due to a lack of information regarding the effects of buprenorphine on the
      developing fetus and infant. Pilot work by this research team suggests that buprenorphine- as
      compared to methadone-exposed fetuses display more optimal neurobehavioral functioning in the
      second and third trimesters of pregnancy. Although these results are encouraging, there is a
      critical need to explore fully the effects of this medication on the fetus and infant to
      adequately advise care providers and patients regarding its use. This is particularly true
      given the imminent publication of a pivotal study comparing buprenorphine to methadone
      treatment during pregnancy which has suggested the optimality of buprenorphine for the
      treatment of opioid dependence during pregnancy, and is likely to result in increasing
      numbers of women being treated with off-label buprenorphine during pregnancy. This proposal
      seeks to explore the effect of buprenorphine on maternal physiology and fetal neurobehavioral
      functioning longitudinally as a measure of the development of the fetal nervous system.
      Additionally, the neurobehavioral profile and NAS of the buprenorphine-exposed infant up to
      one month will be delineated in an effort to provide information necessary to provide optimal
      pharmacologic and non-pharmacologic treatment of NAS. Furthermore, this group has previously
      explored similar parameters in methadone-exposed fetuses and infants, and results of this
      study can be compared to those historical data. These parameters will advance our
      understanding of the way the investigators view and implement the future pharmacologic
      treatment of the opiate dependent woman during pregnancy and her infant after birth, and
      inform clinicians, health insurance companies and regulatory agencies in the provision of
      optimal care to the opioid dependent pregnant woman and her offspring before and after birth.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention description(s): Daily sublingual buprenorphine treatment of pregnant, opioid dependent women from up to 34 weeks gestation through one month of infant age.
Other intervention name(s): Subutex
Intervention MeSH terms: Buprenorphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Buprenorphine; Methadone; Fetal neurobehavior; Infant neurobehavior