MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study

Summary

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.

Conditions

• Opioid-use Disorder
• Neonatal Abstinence Syndrome
• Pregnancy, High Risk
• Alcohol Use Disorder

Interventions

OTHER

Pharmacokinetic analysis

Pharmacokinetic analysis of maternal blood, maternal urine, cord blood, infant blood and urine for dyads in the naltrexone group at various time points in the pregnancy, at delivery, and 4 weeks postpartum.

OTHER

Safety and Efficacy

Examination of the safety and efficacy of naltrexone and comparison of outcomes with the buprenorphine/naloxone cohort. Outcomes examined will include: 1) maternal outcomes (relapse, retention in care, preterm labor); 2) fetal outcomes (growth, fetal anomalies, fetal distress, cortisol levels); and 3) infant outcomes (NAS, growth, neurodevelopment via NNNS exam at 4 weeks and Bayley exam at 12 months of age).

GENETIC

Genetic and epigenetic analysis

Maternal blood and saliva DNA samples will be genotyped for single nucleotide polymorphisms in the mu opioid receptor gene (OPRM1) to look for associations with effectiveness of NTX and BPH. In addition, DNA methylation levels in the OPRM1 promoter within maternal and infant saliva and placenta at delivery and 4 weeks postpartum will be examined. Lastly, we will compare genome-wide DNA methylation levels at delivery and 4 weeks postpartum in mother-infant dyads.

OTHER

Breast milk analysis

Mothers in the naltrexone group will have their breast milk analyzed at 4 weeks post-delivery for naltrexone levels, with corresponding maternal and infant plasma levels.

Sponsors & Collaborators

• University of North Carolina

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Boston University

  collaborator OTHER

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Boston Medical Center

  lead OTHER

Principal Investigators

• Elisha Wachman, MD · Boston Medical Center

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-01

Primary Completion

2024-05-08

Completion

2024-05-08

Countries

• United States

Study Locations