| Eligibility |
Specific Aim 1:
Inclusion Criteria:
1. Singleton gestation between 14-35 weeks
2. On a stable BUP dose (for at least 2 weeks) through a MAT program or just starting BUP
therapy through a MAT program.
3. Willingness to consent to the study and for those on a stable BUP dose, willingness to
experience mild, temporary withdrawal symptoms
Exclusion Criteria:
1. Multifetal gestation, major fetal malformation
2. Urine drug screen results positive for benzodiazepines, cocaine, heroin, barbiturates,
phencyclidine (PCP), or opioids other than BUP
1. Subjects already enrolled in a MAT program must have negative urine drug screens
at the Pre-Study Screening and again on the day of the PD study.
2. Subjects initiating BUP therapy will have a comprehensive drug screen performed
on the day of the PD study. Results that are positive for the presence of
cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP) or opioids
other than BUP will be documented, but will not be used to determine eligibility
for the study.
3. Currently taking more than one mental health medication
4. Active moderately severe depression (PHQ-9 score =15 or suicidal ideation)
5. Clinical signs of intoxication or mental disorientation at time of study
6. Uncontrolled hypertension
7. HIV or AIDS
8. Diagnosis of schizoaffective disorder or psychosis
Specific Aim 2:
Inclusion Criteria:
1. Singleton gestation greater than 37 0/7 weeks
2. Mother on BUP for at least 8 weeks prior to delivery.
3. Mother in a MAT program.
4. Infant with 5 minute Apgar scores >/= 6.
5. No maternal cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP), or
opioids other than BUP in last 8 weeks of pregnancy, based on the urine drug screen
results from the MAT clinic.
Exclusion Criteria:
1. Major fetal/neonatal malformation.
2. Delivery at non-study hospital.
3. Fetal growth restriction - BW < 10th percentile
4. Known fetal renal or hepatic disease that affects drug metabolism or elimination
5. Infant on ventilator support
6. HIV or AIDS
Specific Aim 3:
Part 1:
Inclusion Criteria:
1. Singleton gestation greater than 37 0/7 weeks
2. Mother on BUP for at least 12 weeks prior to delivery and compliant with clinic
policies
3. Willingness to consent to the collection of biological samples; at a minimum, she must
consent to a maternal hair sample, as well as a neonate hair sample and/or meconium.
4. Availability of prenatal records from Ob care provider and BUP dosing records
5. Infant with 5 minute Apgar scores = 6
Exclusion Criteria:
1. Multifetal gestation
2. Major fetal malformation
3. HIV or AIDS
4. Planned delivery at another institution
5. Medical or obstetrical complications in current pregnancy including: preeclampsia,
poorly controlled diabetes or hypertension, or fetal growth restriction
6. Use of cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP), or opioids
other than BUP in the last 12 weeks of pregnancy, based on urine drug screen results
from the MAT clinic
7. Currently taking more than one mental health medication
8. Active moderately severe depression (PHQ-9 score =15 or suicidal ideation)
9. Alcohol abuse anytime during the current pregnancy
Specific Aim 3:
Part 2:
Inclusion Criteria
1. Single gestation between 35 0/7 and 38 0/7 weeks at the time of fetal imaging
2. Mother on BUP or methadone for at least 12 weeks prior to delivery and compliant with
clinic policies
3. Willingness to consent to study requirements; at a minimum, she must consent to a
fetal and neonatal MRI, maternal hair sample, as well as a neonate hair sample and/or
meconium.
4. Availability of prenatal records from Ob care provider and BUP or methadone dosing
records
Exclusion Criteria
1. Multifetal gestation
2. Major fetal malformation
3. HIV or AIDS
4. Medical or obstetrical complications in current pregnancy including: preeclampsia,
poorly controlled diabetes or hypertension, or fetal growth restriction
5. Current use of cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP), or
opioids other than BUP or methadone based on the comprehensive urine drug screen
performed within 1-2 weeks prior to the fetal MRI exam.
Use of cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP), or opioids
other than BUP or methadone in last 12 weeks prior to the fetal MRI exam, based on
urine drug screen results from the MAT clinic
6. Currently taking more than one mental health medication
7. Active moderately severe depression (PHQ-9 score =15 or suicidal ideation)
8. Alcohol abuse anytime during the current pregnancy
9. Any contraindication to MRI such as a pacemaker, claustrophobia, or any metallic
implant
10. Current or recent (last 2 years) history of incarceration
Specific Aim 4:
Inclusion Criteria:
1. On a stable BID, TID or QID dosing regimen of BUP for at least 2 weeks as part of an
established medication- assisted treatment (MAT) program.
2. Willingness to undergo supervised dose reduction
3. Subjects on BID, TID or QID dosing, willingness to be assigned to either the
Magnitude, Interval/Frequency, or Dosing group, depending on their current dosing.
4. Single gestation between 14-30 weeks at the initiation of the dose reduction
5. On a BUP dose between 6- 24 mg daily (lower doses will not provide sufficient data
points)
6. Willingness to have urine samples tested for drugs of abuse and blood samples tested
for BUP+M concentrations during the Medical Supervised Withdrawal (MSW) clinic
appointments
7. Willingness to attend weekly or biweekly MSW clinic appointments and to have daily
contact via text messaging and to complete daily logs of sleep quality, withdrawal
symptoms and symptoms of craving.
8. Willingness to attend psychosocial support meetings as needed.
Exclusion Criteria:
1. Current use of cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP), or
opioids other than BUP.
2. Currently taking more than two mental health medications
3. Active moderately severe depression (PHQ-9 score =15 or suicidal ideation)
4. Current incarceration
5. Lack of a phone or transportation to and from clinic
6. Major fetal malformation
7. Mother with significant vaginal bleeding or serious medical or obstetrical
complication that could adversely affect the study
8. Planned delivery at another institution
9. HIV or AIDS
10. Diagnosis of schizoaffective disorder or psychosis
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