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

Neonatal Abstinence Syndrome Clinical Trial

— MOPPlus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671410
• Other study ID #: 12D.398
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2012
• Last updated: October 13, 2016
• Start date: August 2012
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. = 37 weeks gestation

2. Exposure to opioids in utero

3. Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment

4. Exposure to benzodiazepines in utero and/or receiving breast milk. Benzodiazepine use is defined as maternal use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth.

Exclusion Criteria:

1. Major congenital malformations and/or intrauterine growth retardation defined as birth weight <2200 gm

2. Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.

3. Hypoglycemia requiring treatment with intravenous dextrose

4. Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)

5. Seizure activity or other neurologic abnormality

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

Drug:
• oral morphine
Oral morphine for the treatment of neonatal abstinence syndrome
• sublingual buprenorphine
Sublingual buprenorphine for the treatment of neonatal abstinence syndrome

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feeding patterns	To compare the feeding patterns, weight gain, and incidence of feeding dysfunction in infants treated with sublingual buprenorphine and oral morphine for NAS	Patients will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Other	Respiratory Patterns	To compare the respiratory patterns of infants receiving sublingual buprenorphine or morphine solution for the pharmacologic treatment of NAS after in utero exposure to opioids and benzodiazepines and/or postnatal breast milk.	Patients will be followed for the duration of hospital stay, an expected average of 5 weeks	Yes
Primary	Length of treatment	This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.	Patients will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Secondary	Length of hospitalization	This endpoint will compare length of stay (in days) using sublingual buprenorphine or oral morphine	Patients will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Secondary	Number of patients requiring supplemental phenobarbital treatment	This endpoint will compare requirement number of patients who require use of supplemental phenobarbital for treatment of NAS	Patients will be followed for the duration of hospital stay, an expected average of 5 weeks	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability	Adverse events will be collected, graded by severity, and assessed for causality referent to study drug.	Patients will be followed for the duration of hospital stay, an expected average of 5 weeks	Yes