Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01671410 · ClinicalTrials.gov registry record · Phase 1
Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines
A Phase 1 study of Neonatal Abstinence Syndrome, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT01671410: Completed Phase 1 study of Neonatal Abstinence Syndrome, sponsored by Thomas Jefferson University.
NCT01671410 is a Phase 1 study of Neonatal Abstinence Syndrome that has completed, run by Thomas Jefferson University. The registered enrollment target is 11 participants, below the 66-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01671410, a Phase 1 study of Neonatal Abstinence Syndrome, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.
Primary Outcome
This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.
Conditions Studied
Interventions
- DRUG oral morphine
- DRUG sublingual buprenorphine
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
What the finished NCT01671410 record still lists
NCT01671410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 66-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 2 interventions - of which oral morphine is the first listed.
NCT01671410 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01671410 about?
NCT01671410 is a clinical study titled "Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines". The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioid...
What is the current status of trial NCT01671410?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2012-08. Estimated completion is 2016-09.
What conditions does trial NCT01671410 study?
This clinical trial studies the following conditions: Neonatal Abstinence Syndrome.
What interventions are being tested in trial NCT01671410?
The interventions under investigation include: oral morphine (DRUG), sublingual buprenorphine (DRUG).
Who is sponsoring clinical trial NCT01671410?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01671410 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neonatal Abstinence Syndrome
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 NCT01671410's enrollment target sits among peer trials
11 18th of 17 the lowest of 17 other Neonatal Abstinence Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neonatal Abstinence Syndrome 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
-
Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
COMPLETED · Phase 1
-
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
RECRUITING · NA
-
MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome
RECRUITING
-
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants
ACTIVE NOT RECRUITING · NA
-
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
ACTIVE NOT RECRUITING · NA
-
Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
ACTIVE NOT RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03114462 · 11 participants · Phase 1
Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
- NCT06039709 · 11 participants · Phase 1
Sonodynamic Therapy in Patients With Recurrent GBM
- NCT06425380 · 11 participants · NA
Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy
- NCT06472661 · 11 participants · Early Phase 1
FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia