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NCT03718104 · ClinicalTrials.gov registry record
MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study
A clinical trial of Opioid Use Disorder and Alcohol Use Disorder, sponsored by Boston Medical Center.
- Completed
- Registry status
- 46
- Enrollment target
- 2
- Study locations
NCT03718104 is a study of Opioid Use Disorder and Alcohol Use Disorder that has completed, run by Boston Medical Center. The registered enrollment target is 46 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT03718104, a study of Opioid Use Disorder and Alcohol Use Disorder, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- 46 participants
- Enrollment target
- 2
- Study locations
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 Studied
Interventions
- OTHER Pharmacokinetic analysis
- OTHER Safety and Efficacy
- GENETIC Genetic and epigenetic analysis
- OTHER Breast milk analysis
Study Locations (2)
Massachusetts
- Boston Medical Center - Boston
North Carolina
- University of North Carolina Chapel Hill - Carrboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-12-01 |
| Est. Completion | 2024-05-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03718104
The ClinicalTrials.gov registry entry for NCT03718104 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 4 interventions - of which Pharmacokinetic analysis is the first listed.
NCT03718104 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03718104 about?
NCT03718104 is a clinical study titled "MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study". 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...
What is the current status of trial NCT03718104?
This trial is currently completed. The enrollment target is 46 participants. The study started on 2018-12-01. Estimated completion is 2024-05-08.
What conditions does trial NCT03718104 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Alcohol Use Disorder, Pregnancy, High Risk, Neonatal Abstinence Syndrome.
What interventions are being tested in trial NCT03718104?
The interventions under investigation include: Pharmacokinetic analysis (OTHER), Safety and Efficacy (OTHER), Genetic and epigenetic analysis (GENETIC), Breast milk analysis (OTHER).
Who is sponsoring clinical trial NCT03718104?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03718104 being conducted?
This trial has 2 study locations across Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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