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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03718104




Registration number
NCT03718104
Ethics application status
Date submitted
19/10/2018
Date registered
24/10/2018

Titles & IDs
Public title
MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study
Scientific title
Safety, Efficacy, Pharmacokinetics, and Pharmacogenomics of Extended-Release Naltrexone in Pregnant Women
Secondary ID [1] 0 0
R01HD096798-01
Secondary ID [2] 0 0
H-37773
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid-use Disorder 0 0
Neonatal Abstinence Syndrome 0 0
Pregnancy, High Risk 0 0
Alcohol Use Disorder 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Pharmacokinetic analysis
Other interventions - Safety and Efficacy
Treatment: Other - Genetic and epigenetic analysis
Other interventions - Breast milk analysis

Naltrexone - 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.

Buprenorphine/Naloxone - 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.

Naltrexone - alcohol use disorder - 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.


Other interventions: 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 interventions: 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).

Treatment: Other: 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 interventions: 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.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maternal drug use relapse
Timepoint [1] 0 0
up to 12 months post-delivery
Secondary outcome [1] 0 0
Naltrexone side effects or adverse events
Timepoint [1] 0 0
up to 12 months post-delivery
Secondary outcome [2] 0 0
Fetal heart rate monitoring from NST
Timepoint [2] 0 0
27- 41 weeks gestation
Secondary outcome [3] 0 0
Biophysical profile score calculated from NST
Timepoint [3] 0 0
27 - 41 weeks gestation
Secondary outcome [4] 0 0
Maternal hair cortisol levels
Timepoint [4] 0 0
Birth and 4 weeks post-delivery
Secondary outcome [5] 0 0
Infant hair cortisol levels
Timepoint [5] 0 0
Birth and 4 weeks post-delivery
Secondary outcome [6] 0 0
Fetal growth based on ultrasound measurements
Timepoint [6] 0 0
18 - 41 weeks gestation
Secondary outcome [7] 0 0
Congenital fetal anomalies by ultrasound
Timepoint [7] 0 0
18 - 41 weeks gestation
Secondary outcome [8] 0 0
Congenital anomalies by physical examination
Timepoint [8] 0 0
Birth
Secondary outcome [9] 0 0
Diagnosis of Neonatal Abstinence Syndrome (NAS)
Timepoint [9] 0 0
From birth to 30 days
Secondary outcome [10] 0 0
Infant need for pharmacologic treatment
Timepoint [10] 0 0
From birth to 30 days
Secondary outcome [11] 0 0
Infant need for adjunctive agent
Timepoint [11] 0 0
From birth to 30 days
Secondary outcome [12] 0 0
Infant opioid replacement pharmacologic treatment
Timepoint [12] 0 0
From birth to 30 days
Secondary outcome [13] 0 0
Infant birth hospitalization length of stay
Timepoint [13] 0 0
From birth to 30 days
Secondary outcome [14] 0 0
Infant weight
Timepoint [14] 0 0
Birth, 4 weeks, and 12 months
Secondary outcome [15] 0 0
Infant length
Timepoint [15] 0 0
Birth, 4 weeks, and 12 months
Secondary outcome [16] 0 0
Infant head circumference
Timepoint [16] 0 0
Birth, 4 weeks, and 12 months
Secondary outcome [17] 0 0
Infant neurobehavior-function assessed by the NNNS
Timepoint [17] 0 0
4 weeks of age
Secondary outcome [18] 0 0
Infant neurodevelopment assessed by Bayley III
Timepoint [18] 0 0
12 months of age
Secondary outcome [19] 0 0
Pharmacokinetic analysis of maternal naltrexone levels
Timepoint [19] 0 0
2nd trimester, 3rd trimester, delivery, 2-4 days after delivery, 4 weeks post-delivery
Secondary outcome [20] 0 0
Pharmacokinetic analysis of infant naltrexone levels
Timepoint [20] 0 0
Delivery, 2-4 days after delivery, 4 weeks post-delivery

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina

Funding & Sponsors
Primary sponsor type
Other
Name
Boston Medical Center
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of North Carolina
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of California, San Diego
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Boston University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elisha Wachman, MD
Address 0 0
Boston Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Elisha Wachman, MD
Address 0 0
Country 0 0
Phone 0 0
617-414-3690
Fax 0 0
Email 0 0
Elisha.Wachman@bmc.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03718104