NCT01671410

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

A Randomized, Open Label Clinical Trial of Buprenorphine in the Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines or Are Breastfeeding

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Infants with in utero exposure to opioids often require therapy with morphine for an extended period. In a clinical trial, sublingual buprenorphine reduced this treatment period by \~30%. However, infants with both opioid and benzodiazepine exposure were not included in the trial. This study will test the safety and tolerability of sublingual buprenorphine in infants with in utero exposure to benzodiazepines or who are breastfeeding.

Conditions

• Neonatal Abstinence Syndrome

Interventions

Type	Name	Description
DRUG	oral morphine	Oral morphine for the treatment of neonatal abstinence syndrome
DRUG	sublingual buprenorphine	Sublingual buprenorphine for the treatment of neonatal abstinence syndrome

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2012-08-23
• Last updated: 2016-10-14

Locations

1 site across 1 country: United States