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

Primary Purpose

Neonatal Abstinence Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oral morphine
sublingual buprenorphine
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Abstinence Syndrome focused on measuring Neonatal Abstinence Syndrome, buprenorphine, morphine, benzodiazepine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sublingual buprenorphine

oral morphine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2012
Last Updated
October 13, 2016
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT01671410
Brief Title
Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome
Keywords
Neonatal Abstinence Syndrome, buprenorphine, morphine, benzodiazepine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sublingual buprenorphine
Arm Type
Experimental
Arm Description
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
Arm Title
oral morphine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
oral morphine
Other Intervention Name(s)
morphine
Intervention Description
Oral morphine for the treatment of neonatal abstinence syndrome
Intervention Type
Drug
Intervention Name(s)
sublingual buprenorphine
Other Intervention Name(s)
buprenex
Intervention Description
Sublingual buprenorphine for the treatment of neonatal abstinence syndrome
Primary Outcome Measure Information:
Title
Length of treatment
Description
This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary Outcome Measure Information:
Title
Length of hospitalization
Description
This endpoint will compare length of stay (in days) using sublingual buprenorphine or oral morphine
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Title
Number of patients requiring supplemental phenobarbital treatment
Description
This endpoint will compare requirement number of patients who require use of supplemental phenobarbital for treatment of NAS
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Title
Number of participants with adverse events as a measure of safety and tolerability
Description
Adverse events will be collected, graded by severity, and assessed for causality referent to study drug.
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Other Pre-specified Outcome Measures:
Title
Feeding patterns
Description
To compare the feeding patterns, weight gain, and incidence of feeding dysfunction in infants treated with sublingual buprenorphine and oral morphine for NAS
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
Title
Respiratory Patterns
Description
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.
Time Frame
Patients will be followed for the duration of hospital stay, an expected average of 5 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter K Kraft, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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