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

NCT01671410 | Completed Phase 1 DMC

• 1 other identifier: 12D.398
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neonatal Abstinence Syndrome; buprenorphine; morphine; benzodiazepine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Length of hospitalization

  Patients will be followed for the duration of hospital stay, an expected average of 5 weeks

• Number of patients requiring supplemental phenobarbital treatment

  Patients will be followed for the duration of hospital stay, an expected average of 5 weeks

• Number of participants with adverse events as a measure of safety and tolerability

  Patients will be followed for the duration of hospital stay, an expected average of 5 weeks

Other Outcomes (2)

• Feeding patterns

  Patients will be followed for the duration of hospital stay, an expected average of 5 weeks

• Respiratory Patterns

  Patients will be followed for the duration of hospital stay, an expected average of 5 weeks

Study Arms (2)

sublingual buprenorphine

EXPERIMENTAL

Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose

Drug: sublingual buprenorphine

oral morphine

ACTIVE COMPARATOR

Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours

Drug: oral morphine

Interventions

oral morphine DRUG

Oral morphine for the treatment of neonatal abstinence syndrome

Also known as: morphine

oral morphine

sublingual buprenorphine DRUG

Sublingual buprenorphine for the treatment of neonatal abstinence syndrome

Also known as: buprenex

sublingual buprenorphine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 37 weeks gestation
• Exposure to opioids in utero
• Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment
• 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.

You may not qualify if:

• Major congenital malformations and/or intrauterine growth retardation defined as birth weight \<2200 gm
• Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.
• Hypoglycemia requiring treatment with intravenous dextrose
• Seizure activity or other neurologic abnormality

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Morphine; Buprenorphine

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Walter K Kraft, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 23, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

US (1)