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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03291847
The ClinicalTrials.gov registry entry for NCT03291847 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Buprenorphine Naloxone is the first listed.
NCT03291847 reports 0 study locations.
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.
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