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NCT Number: NCT01671410

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 opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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.

Exclusion criteria

  • 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
  • Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)
  • Seizure activity or other neurologic abnormality

Treatment and study plan

Oral morphine

Drug

Oral morphine for the treatment of neonatal abstinence syndrome

Other names: morphine

sublingual buprenorphine

Drug

Sublingual buprenorphine for the treatment of neonatal abstinence syndrome

Other names: buprenex

Primary outcomes

  1. Length of treatment

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

    This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.

Secondary outcomes

  1. Length of hospitalization

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

    This endpoint will compare length of stay (in days) using sublingual buprenorphine or oral morphine

  2. Number of patients requiring supplemental phenobarbital treatment

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

    This endpoint will compare requirement number of patients who require use of supplemental phenobarbital for treatment of NAS

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

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

    Adverse events will be collected, graded by severity, and assessed for causality referent to study drug.

Other outcomes

  1. Feeding patterns

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

    To compare the feeding patterns, weight gain, and incidence of feeding dysfunction in infants treated with sublingual buprenorphine and oral morphine for NAS

  2. Respiratory Patterns

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

    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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study 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

Acronym: MOPPlus

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Aug 23, 2012
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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