Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy
Opiate Addiction, Pregnancy
About this trial
This is an interventional treatment trial for Opiate Addiction focused on measuring Buprenorphine, medication-assisted treatment (MAT) programs
Eligibility Criteria
Specific Aim 1:
Inclusion Criteria:
- Singleton gestation between 14-35 weeks
- On a stable BUP dose (for at least 2 weeks) through a MAT program or just starting BUP therapy through a MAT program.
- Willingness to consent to the study and for those on a stable BUP dose, willingness to experience mild, temporary withdrawal symptoms
Exclusion Criteria:
- Multifetal gestation, major fetal malformation
Urine drug screen results positive for benzodiazepines, cocaine, heroin, barbiturates, phencyclidine (PCP), or opioids other than BUP
- 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.
- 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.
- Currently taking more than one mental health medication
- Active moderately severe depression (PHQ-9 score ≥15 or suicidal ideation)
- Clinical signs of intoxication or mental disorientation at time of study
- Uncontrolled hypertension
- HIV or AIDS
- Diagnosis of schizoaffective disorder or psychosis
Specific Aim 2:
Inclusion Criteria:
- Singleton gestation greater than 37 0/7 weeks
- Mother on BUP for at least 8 weeks prior to delivery.
- Mother in a MAT program.
- Infant with 5 minute Apgar scores >/= 6.
- 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:
- Major fetal/neonatal malformation.
- Delivery at non-study hospital.
- Fetal growth restriction - BW < 10th percentile
- Known fetal renal or hepatic disease that affects drug metabolism or elimination
- Infant on ventilator support
- HIV or AIDS
Specific Aim 3:
Part 1:
Inclusion Criteria:
- Singleton gestation greater than 37 0/7 weeks
- Mother on BUP for at least 12 weeks prior to delivery and compliant with clinic policies
- 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.
- Availability of prenatal records from Ob care provider and BUP dosing records
- Infant with 5 minute Apgar scores ≥ 6
Exclusion Criteria:
- Multifetal gestation
- Major fetal malformation
- HIV or AIDS
- Planned delivery at another institution
- Medical or obstetrical complications in current pregnancy including: preeclampsia, poorly controlled diabetes or hypertension, or fetal growth restriction
- 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
- Currently taking more than one mental health medication
- Active moderately severe depression (PHQ-9 score ≥15 or suicidal ideation)
- Alcohol abuse anytime during the current pregnancy
Specific Aim 3:
Part 2:
Inclusion Criteria
- Single gestation between 35 0/7 and 38 0/7 weeks at the time of fetal imaging
- Mother on BUP or methadone for at least 12 weeks prior to delivery and compliant with clinic policies
- 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.
- Availability of prenatal records from Ob care provider and BUP or methadone dosing records
Exclusion Criteria
- Multifetal gestation
- Major fetal malformation
- HIV or AIDS
- Medical or obstetrical complications in current pregnancy including: preeclampsia, poorly controlled diabetes or hypertension, or fetal growth restriction
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
- Currently taking more than one mental health medication
- Active moderately severe depression (PHQ-9 score ≥15 or suicidal ideation)
- Alcohol abuse anytime during the current pregnancy
- Any contraindication to MRI such as a pacemaker, claustrophobia, or any metallic implant
- Current or recent (last 2 years) history of incarceration
Specific Aim 4:
Inclusion Criteria:
- 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.
- Willingness to undergo supervised dose reduction
- 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.
- Single gestation between 14-30 weeks at the initiation of the dose reduction
- On a BUP dose between 6- 24 mg daily (lower doses will not provide sufficient data points)
- 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
- 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.
- Willingness to attend psychosocial support meetings as needed.
Exclusion Criteria:
- Current use of cocaine, heroin, benzodiazepines, barbiturates, phencyclidine (PCP), or opioids other than BUP.
- Currently taking more than two mental health medications
- Active moderately severe depression (PHQ-9 score ≥15 or suicidal ideation)
- Current incarceration
- Lack of a phone or transportation to and from clinic
- Major fetal malformation
- Mother with significant vaginal bleeding or serious medical or obstetrical complication that could adversely affect the study
- Planned delivery at another institution
- HIV or AIDS
- Diagnosis of schizoaffective disorder or psychosis
Sites / Locations
- Univerity of Pittsburgh Magee-Womens HospitalRecruiting
- High Risk Obstetrical Consultants
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Buprenorphine Magnitude Group
Buprenorphine Frequency Group
Buprenorphine Dosing Group
Subjects will receive alternating reductions of 1 mg and then 2 mg weekly. Subjects on thrice daily (TID) or four times daily (QID) dosing, as prescribed by their MAT provider, will be assigned to either the Magnitude or Frequency group (n=10).
Subjects will receive dose reductions of 2 mg on alternating intervals of 1 and 2 weeks. Subjects on TID or QID dosing, as prescribed by their MAT provider, will be assigned to either the Magnitude or Frequency group (n=10).
Subjects will receive dose reductions identical to either the Magnitude (alternating 1 and 2 mg reductions) or Frequency (2 mg reductions on alternating 1 and 2 week intervals) groups. Subjects on BID dosing, as prescribed by their MAT provider, will be assigned to the Dosing group (n=10).