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NCT01561079 · ClinicalTrials.gov registry record · Phase 2
Fetal and Infant Effects of Maternal Buprenorphine Treatment
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 127
- Enrollment target
NCT01561079: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT01561079 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 127 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01561079, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 127 participants
- Enrollment target
Study Summary
This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation, the relationship between maternal physiologic changes due to buprenorphine administration and newborn functioning, and to determine potential fetal neurobehavioral markers that may predict Neonatal Abstinence Syndrome expression and infant neurobehavioral outcome. Comparisons to results from a similar project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way the investigators inform the treatment of the opioid dependent woman during pregnancy and her infant after birth.
Interventions
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01561079
The ClinicalTrials.gov registry entry for NCT01561079 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 127 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 1 intervention - of which Buprenorphine is the first listed.
NCT01561079 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01561079 about?
NCT01561079 is a clinical study titled "Fetal and Infant Effects of Maternal Buprenorphine Treatment". This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation, the relationship between maternal physiologic changes due to buprenorphin...
What is the current status of trial NCT01561079?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2012-02. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01561079?
The interventions under investigation include: Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01561079?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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