MedTrace Logo

Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines

NCT01671410 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-10-14

No results posted yet for this 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.

Conditions

  • Neonatal Abstinence Syndrome

Interventions

DRUG

oral morphine

Oral morphine for the treatment of neonatal abstinence syndrome

DRUG

sublingual buprenorphine

Sublingual buprenorphine for the treatment of neonatal abstinence syndrome

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Walter K Kraft, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01671410 on ClinicalTrials.gov