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Completed

NCT Number: NCT03291847

Maternal Buprenorphine-naloxone Treatment and the Infant

The purpose of this mechanistic study is to evaluate the effects that maternal buprenorphine-naloxone maintenance have on the neurobehavioral development of the fetus and infant. To accomplish this, the investigators will study a sample of 120 opioid dependent pregnant women that will receive buprenorphine-naloxone as part of substance abuse treatment at a comprehensive care treatment facility for pregnant and parenting women with substance use disorders. Fetal neurobehavior and maternal physiology will be assessed, via an established maternal-fetal data acquisition system, at 4 points during gestation: 24, 28, 32 and 36 weeks. Infant birth parameters and Neonatal Abstinence Syndrome (NAS) spectrum display will be evaluated at birth, and infant neurodevelopment will be assessed during the first month of life.

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Key information

Conditions

Maternal Opioid Use Disorder Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Neonatal Abstinence Syndrome Opioid Exposed Infant Substance-Related Disorders

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

About this study

The project population will be 40 pregnant women with opioid use disorder inducted as outpatients to buprenorphine-naloxone maintenance. Subject treatment data, including medical and obstetric histories, drug use histories, demographic information and psychosocial information will be extracted from patient charts. Weekly urine toxicology testing will provide information regarding other substance use/misuse during the time of study participation. Study participants will undergo 2 60 minute maternal and fetal neurophysiologic monitoring sessions on one day at 4 points during gestation: 24, 28, 32 and 36 weeks, at times of trough (just before sublingual buprenorphine-naloxone or methadone daily dose) and peak (2 1/2 hours after dosing) maternal drug levels. Fetal cardiac (heart rate, heart rate variability, heart rate accelerations) and movement (total fetal movement, number and duration of movement bouts) and the correlation between the two (fetal heart rate-movement coupling) will be determined. Maternal physiologic measures will include heart period and variability, vagal tone, skin conductance and respiratory data. All maternal and fetal measures, with the exception of blood pressure, will be computed in 1-minute intervals and averaged over the 60 min recording. Infant birth data and birth parameters, and neonatal abstinence syndrome scores will be extracted from patient charts. Infants will undergo neurobehavioral testing using the Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale, a 30 minute harmless assessment of infant functioning, on days 3, 14 and 30 of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current opioid use disorder (OUD) as defined by DSM V criteria
  • singleton pregnancies, generally uncomplicated by conditions that jeopardize pregnancy outcome
  • Gestation less than 24 weeks

Exclusion criteria

  • Complications of pregnancy, including gestational diabetes, polyhydramnios, hypertension, placenta previa or significant risk of preterm delivery;
  • 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;
  • Alcohol use disorder per DSM V criteria (see ascertainment methods below)
  • Women stable on methadone maintenance (defined as more than 3 consecutive days of dosing)
  • Women coming to treatment reporting "street" methadone use (for more than 3 consecutive days
  • Women not planning to receive obstetric care at the Center for Addiction and Pregnancy; - Women not planning to deliver their infants at Johns Hopkins Bayview Medical center
  • Women planning for adoption of their infant.

Treatment and study plan

fetal monitoring

Device

Maternal fetal monitoring

Other names: maternal physiology monitoring

Buprenorphine Naloxone

Drug

Treatment for opioid use disorder

Other names: Suboxone

Primary outcomes

  1. Fetal Heart Rate at 24 Weeks

    Time frame: 24 weeks of gestation

    Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate in msec at 24 weeks of gestation at times of peak maternal plasma drug concentrations

  2. Fetal Heart Rate at 28 Weeks Gestation

    Time frame: 28 weeks of gestation

    Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate at 28 weeks of gestation at times of tpeak maternal plasma drug concentrations.

  3. Fetal Heart Rate at 32 Weeks Gestation

    Time frame: 32 weeks of gestation

    Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 32 weeks of gestation at times of peak maternal plasma drug concentrations

  4. Fetal Heart Rate at 36 Weeks Gestation

    Time frame: 36 weeks of gestation

    Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 36 weeks of gestation at times of peak maternal plasma drug concentrations.

  5. Total Fetal Movement at 24 Weeks Gestation

    Time frame: 24 weeks of gestation

    Total fetal movement at 24 weeks of gestation. Total number of fetal moves over 60 minutes via fetal monitoring at time of peak maternal plasma drug concentrations at 24 weeks of gestation.

  6. Total Fetal Movement at 36 Weeks Gestation

    Time frame: 36 weeks of gestation

    Total fetal movement over 60 minutes via fetal monitoring at 36 weeks of gestation. Nimber of fetal movements over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 36 weeks of gestation.

  7. Total Fetal Movement at 28 Weeks Gestation

    Time frame: 28 weeks of gestation

    Total fetal movement over 60 minutes via fetal monitoring. Total fetal movement over 60 minutes via fetal monitoring at times of trough and peak maternal plasma drug concentrations at 28 weeks of gestation.

  8. Total Fetal Movement at 32 Weeks Gestation

    Time frame: 32 weeks of gestation

    Total fetal movement over 60 minutes via fetal monitoring at 32 weeks of gestation. Number of fetal moves over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 32 weeks of gestation.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Maternal Buprenorphine-naloxone Treatment During the Perinatal Period: Fetal and Infant Effects

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Sep 25, 2017
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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