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NCT03291847 · ClinicalTrials.gov registry record · Phase 2
Maternal Buprenorphine-naloxone Treatment and the Infant
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT03291847: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT03291847 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03291847, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of this mechanistic study is to evaluate the effects that maternal buprenorphine-naloxone maintenance have on the neurobehavioral development of the fetus and infant. To accomplish this, the investigators will study a sample of 120 opioid dependent pregnant women that will receive buprenorphine-naloxone as part of substance abuse treatment at a comprehensive care treatment facility for pregnant and parenting women with substance use disorders. Fetal neurobehavior and maternal physiology will be assessed, via an established maternal-fetal data acquisition system, at 4 points during gestation: 24, 28, 32 and 36 weeks. Infant birth parameters and Neonatal Abstinence Syndrome (NAS) spectrum display will be evaluated at birth, and infant neurodevelopment will be assessed during the first month of life.
Primary Outcome
Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate in msec at 24 weeks of gestation at times of peak maternal plasma drug concentrations
Interventions
- DRUG Buprenorphine Naloxone
- DEVICE fetal monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2023-12-15 |
| Phase | Phase 2 |
What the finished NCT03291847 record still lists
NCT03291847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Buprenorphine Naloxone is the first listed.
NCT03291847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03291847 about?
NCT03291847 is a clinical study titled "Maternal Buprenorphine-naloxone Treatment and the Infant". The purpose of this mechanistic study is to evaluate the effects that maternal buprenorphine-naloxone maintenance have on the neurobehavioral development of the fetus and infant. To accomplish this, the investigators will study a sample of 120 opioid dependent pregnant women that will receive bupren...
What is the current status of trial NCT03291847?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2018-06-01. Estimated completion is 2023-12-15.
What interventions are being tested in trial NCT03291847?
The interventions under investigation include: Buprenorphine Naloxone (DRUG), fetal monitoring (DEVICE).
Who is sponsoring clinical trial NCT03291847?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03291847's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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