Clinical trial NCT03291847: Maternal Buprenorphine-naloxone Treatment and the Infant
Official title: Maternal Buprenorphine-naloxone Treatment During the Perinatal Period: Fetal and Infant Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Maternal Opioid Use Disorder
Opioid Exposed Infant
Keywords: maternal opioid use
neonatal abstinence syndrome
buprenorphine-naloxone
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-09-25
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A group of n=40 study participants will receive buprenorphine-naloxone medication assisted therapy for the treatment of opioid use disorder during pregnancy. This group will undergo fetal monitoring at 24, 28, 32 and 36 weeks of gestation.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fetal Heart Rate at 24 Weeks
timeFrame: 24 weeks of gestation
measure: Fetal Heart Rate at 28 Weeks Gestation
timeFrame: 28 weeks of gestation
measure: Fetal Heart Rate at 32 Weeks Gestation
timeFrame: 32 weeks of gestation
measure: Fetal Heart Rate at 36 Weeks Gestation
timeFrame: 36 weeks of gestation
measure: Total Fetal Movement at 24 Weeks Gestation
timeFrame: 24 weeks of gestation
measure: Total Fetal Movement at 36 Weeks Gestation
timeFrame: 36 weeks of gestation
measure: Total Fetal Movement at 28 Weeks Gestation
timeFrame: 28 weeks of gestation
measure: Total Fetal Movement at 32 Weeks Gestation
timeFrame: 32 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lauren M Jansson, MD
role: PRINCIPAL_INVESTIGATOR
References: