Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

Phase 4

Withdrawn

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
buprenorphine/naloxone	Buprenorphine/naloxone	Buprenorphine/naloxone 4 mg/1 mg daily once daily or twice daily (BID): Light to moderate history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 5-24 Buprenorphine/naloxone 8 mg/2 mg daily once daily or twice daily (BID): Heavy history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 25-36+
buprenorphine	Buprenorphine	Buprenorphine 2 mg to 8 mg daily: Light to moderate history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 5-24 Buprenorphine 8 mg to 16 mg daily: Heavy history of opioid use (heroin, oxycodone, etc.) and/or Clinical Opioid Withdraw Scale (COWS) scores 25-36+

Primary Outcome Measures

Name	Time	Method
Compliance antepartum	From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)	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.
Compliance postpartum	2 month period 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).
Dosing antepartum	From entry into the study until delivery (through study completion, an average of 9 months which is duration of the pregnancy)	Evaluate all women for the need a significant dosing change in buprenorphine or buprenorphine/naloxone (\>50% increase or decrease) during pregnancy.
Dosing postpartum	2 month period 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).

Secondary Outcome Measures

Name	Time	Method
Maternal Outcomes Withdraw Scoring	Duration of pregnancy and 2 months of postpartum period	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
Maternal Outcome Metabolites	At delivery of newborn	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)
Placental dysmaturity	At delivery of newborn	Placental histology (obtained at delivery - pathology specimen)
Neonatal Outcomes	Birth until discharge from hospital (performed during hospitalization of newborn from 0 to 30 days of life)	Neonatal Abstinence Syndrome (NAS) rate
Neonatal stay	Birth to newborn discharge home (from day 0 through 120 days of life)	Duration of newborn inpatient hospital stay
Newborn	At birth	Gestational age at birth (range 23 to 43 weeks)