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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: Completed study of Opioid Use Disorder and Alcohol Use Disorder, sponsored by Boston Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Maternal relapse of illicit and/or unprescribed drug use from maternal/provider report and or from urine toxicology testing at any point during the pregnancy and up to 12 months after delivery
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 |
What the finished NCT03718104 record still lists
NCT03718104 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03718104's enrollment target sits among peer trials
46 180th of 257 higher than 77 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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