This study will assesses the efficacy of buprenorphine/naloxone vs buprenorphine on maternal withdrawal symptoms and drug cravings. This is a randomized controlled trial to a cohort of pregnant women seeking medication-assisted treatment for opioid use disorders. Half of participants will receive buprenorphine, while the other half of participants receive a combination of buprenorphine/naloxone
Buprenorphine and Buprenorphine/naloxone each are used to treat opioid use disorders in pregnancy. Buprenorphine has many preferential characteristics over methadone including decreased risk of maternal overdose, lower incidence of preterm labor, less frequent clinical visits, shorter duration of neonatal hospital stay and treatment for neonatal abstinence syndrome. Recent studies have found that increasing the dosing frequencies of buprenorphine is more efficacious to prevent maternal withdrawal symptoms, improve compliance, and theoretically produce better pregnancy outcomes. Buprenorphine/naloxone, a combination opioid of buprenorphine and naloxone, has also been investigated as an alternative to treatment and maintenance for opioid use disorder. The advantage of the combination of buprenorphine with naloxone is that it reduces the potential for abuse. As a partial mu opioid agonist, buprenorphine alone has the capacity to induce typical opioid effects such as euphoria, which are enhanced when the drug is taken intravenously. By combining buprenorphine with naloxone, an opioid antagonist, the capacity for buprenorphine to be abused is reduced.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Buprenorphine/naloxone tablet or film
Buprenorphine tablet
Compliance antepartum
To compare compliance with buprenorphine versus buprenorphine/naloxone medication-assisted treatment (MAT) in pregnant women. Compliance will include the incidence of urine toxicology testing positive for illicit substances during prenatal care and at the time of admission for delivery.
Time frame: From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)
Compliance postpartum
To compare compliance with buprenorphine versus buprenorphine/naloxone medication-assisted treatment (MAT) in the postpartum period. Compliance will include the incidence of urine toxicology testing positive for illicit substances from the time of discharge from the hospital following the delivery over a 2 month period postpartum (postpartum period).
Time frame: 2 month period postpartum
Dosing antepartum
Evaluate all women for the need a significant dosing change in buprenorphine or buprenorphine/naloxone (\>50% increase or decrease) during pregnancy.
Time frame: From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)
Dosing postpartum
Evaluate all women for the need a significant dosing change in buprenorphine or buprenorphine/naloxone (\>50% increase or decrease) from the hospital following the delivery over a 2 month period postpartum (postpartum period).
Time frame: 2 month period postpartum
Maternal Outcomes Withdraw Scoring
Prenatal Clinical Opioid Withdraw Scale (COWS) score and drug cravings score (0 to 48 score) Score interpretation: 5-12 = Mild 13-24 = Moderate 25-36 = Moderately Severe More than 36 = Severe Withdrawal
Time frame: Duration of pregnancy and 2 months of postpartum period
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Maternal Outcome Metabolites
Umbilical cord blood levels of metabolites of buprenorphine (norbuprenorphine, buprenorphine glucuronide, and norbuprenorphine glucuronide) which are obtained from the umbilical cord after delivery of the baby (one time specimen for evaluation)
Time frame: At delivery of newborn
Placental dysmaturity
Placental histology (obtained at delivery - pathology specimen)
Time frame: At delivery of newborn
Neonatal Outcomes
Neonatal Abstinence Syndrome (NAS) rate
Time frame: Birth until discharge from hospital (performed during hospitalization of newborn from 0 to 30 days of life)
Neonatal stay
Duration of newborn inpatient hospital stay
Time frame: Birth to newborn discharge home (from day 0 through 120 days of life)
Newborn
Gestational age at birth (range 23 to 43 weeks)
Time frame: At birth