MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study

Boston Medical Center (BMC)

Status: Completed

Conditions: Opioid-use Disorder; Pregnancy, High Risk; Neonatal Abstinence Syndrome; Alcohol Use Disorder

Treatments: Genetic: Genetic and epigenetic analysis; Other: Safety and Efficacy; Other: Breast milk analysis; Other: Pharmacokinetic analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03718104

R01HD096798-01 (U.S. NIH Grant/Contract)

H-37773

Details and patient eligibility

About

This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared with a cohort treated with buprenorphine/naloxone.

Full description

Fifty pregnant women stabilized pre-pregnancy on oral or extended-release naltrexone (XR-NTX) and 50 comparison women on buprenorphine/naloxone (BPH) from Boston Medical Center and the University of North Carolina will be enrolled in this multi-center prospective comparative cohort study. The specific aims of this project are: 1) Safety and Efficacy: To compare maternal outcomes (safety, relapse, retention in care), fetal outcomes (growth, fetal distress), and infant outcomes (neonatal abstinence syndrome, growth, neurodevelopment) during pregnancy until 12 months post- delivery; An exploratory part of this aim is to collect safety and efficacy data on women receiving NTX for alcohol use disorder (AUD). We will collect maternal, fetal and infant outcomes related to prenatal alcohol exposure. 2) Pharmacokinetics: To determine the pharmacokinetics of NTX in pregnant and postpartum women; 3) Genetics and Epigenetics: To examine the association between genetic variants and epigenetic modification in the mu-opioid receptor (OPRM1) gene, as well as global DNA methylation changes after treatment with NTX and BPH within the mother, placenta, and infant; and 4) Breast milk: To measure breast milk concentrations of NTX and corresponding infant relative dose to determine safety for lactating women.

Enrollment: 46 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women between 6 - 30 6/7 weeks gestation, receiving prenatal care at Boston Medical Center (BMC) or the University of North Carolina (UNC)
• Plan to deliver infant at BMC or UNC
• Diagnosis of opioid use disorder (OUD) or alcohol use disorder (AUD) in the current pregnancy on prescribed oral or extended-release naltrexone; or buprenorphine/naloxone for the treatment of OUD
• English speaking
• Singleton pregnancy

Exclusion criteria

• OUD on prescribed methadone, or no maintenance medication
• OUD on Subutex formulation of buprenorphine
• Severe psychiatric illness or cognitively impairing ability to provide informed consent
• Current maternal incarceration
• Women who present for care >31 0/7 weeks
• Multiple gestation pregnancy

Trial design

46 participants in 3 patient groups

Naltrexone

Description:

Pregnant women with opioid use disorder on prescribed oral or extended-release naltrexone and their infants. Biospecimens collected from this group will undergo pharmacokinetic analysis, genetic and epigenetic analysis, and breast milk analysis. This group will also receive safety and efficacy interventions.

Treatment:

Other: Pharmacokinetic analysis

Other: Breast milk analysis

Other: Safety and Efficacy

Genetic: Genetic and epigenetic analysis

Buprenorphine/Naloxone

Description:

Pregnant women with opioid use disorder on prescribed buprenorphine/naloxone and their infants. Biospecimens collected from this group will undergo genetic and epigenetic analysis and the group will also receive safety and efficacy interventions.

Treatment:

Other: Safety and Efficacy

Genetic: Genetic and epigenetic analysis

Naltrexone - alcohol use disorder

Description:

Pregnant women with alcohol use disorder on prescribed naltrexone (oral or extended-release) and their infants. Biospecimens collected from this group will undergo pharmacokinetic analysis, genetic and epigenetic analysis, and breast milk analysis. This exploratory group will also receive safety and efficacy interventions.

Treatment:

Other: Pharmacokinetic analysis

Other: Breast milk analysis

Genetic: Genetic and epigenetic analysis