Fetal and Infant Effects of Maternal Buprenorphine Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Lauren M. Jansson, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01561079
First received: March 19, 2012
Last updated: March 12, 2014
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Maternal Opioid Dependency
Drug: Buprenorphine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Fetal and Infant Effects of Maternal Buprenorphine Treatment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Longitudinal change in fetal neurobehaviors [ Time Frame: 24, 28, 32 and 36 weeks of gestation ] [ Designated as safety issue: No ]
    Fetal heart rate, fetal heart rate variability, fetal heart rate accelerations, fetal movement, fetal movement-fetal heart rate coupling


Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maternal buprenorphine treatment
Buprenorphine maintenance during pregnancy
Drug: Buprenorphine
Daily sublingual buprenorphine treatment of pregnant, opioid dependent women from up to 34 weeks gestation through one month of infant age.
Other Name: Subutex

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current opioid dependence as defined by DSM IV-R criteria
  • 18-40 years of age with uncomplicated singleton pregnancies
  • Accurate gestational age dating verified by ultrasound
  • Gestation of less than 34 weeks
  • Stabilization on buprenorphine for one week prior to study procedures

Exclusion Criteria:

  • Complications of pregnancy, including gestational diabetes, polyhydramnios, hypertension, placenta previa or significant risk of preterm delivery (i.e. incompetent cervix)
  • Evidence of fetal malformation detected by prenatal ultrasound
  • Significant general maternal health problems that can affect fetal functioning, including Type I or gestational diabetes, alterations in thyroid functioning, HIV infection or hypertension.
  • Significant maternal psychopathology that would preclude informed consent (i.e. schizophrenia)
  • Alcohol dependency per DSM IV R criteria (see ascertainment methods below)
  • Women stable on methadone maintenance (defined as more than 3 days of methadone dosing)
  • Women entering drug treatment reporting using "street" methadone (for more than 3 days)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561079

Contacts
Contact: Lauren M Jansson, MD 4105505438 ljansson@jhmi.edu
Contact: Martha L Velez, MD 4105503414 mvelez@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Krystle Green    410-550-8779    kgreen39@jhmi.edu   
Center for Addiction and Pregnancy Recruiting
Baltimore, Maryland, United States, 21224
Contact: Lauren M. Jansson, M.D.    410-550-5438    ljansson@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Lauren M Jansson, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Lauren M. Jansson, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01561079     History of Changes
Other Study ID Numbers: 00051600
Study First Received: March 19, 2012
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Buprenorphine
Methadone
Fetal neurobehavior
Infant neurobehavior

Additional relevant MeSH terms:
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 24, 2014