Maternal Buprenorphine-naloxone Treatment and the Infant

The project population will be 80 pregnant women with opioid use disorder, 40 inducted as
outpatients to buprenorphine-naloxone maintenance, and 40 matched methadone controls. 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.

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.