Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal

NCT01804075 | Completed Phase 4 Results

• 1 other identifier: 10-1-M-185
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter duration of opiate medication treatment and fewer infants treated with a second drug.

Conditions

Neonatal Abstinence Syndrome

Keywords

NAS; NICU; EMMC

Outcome Measures

Primary Outcomes (1)

• Days of Treatment With Opioid Medication

  The length of time in days that the treatment opioid was used on a measured taper to ameliorate withdrawal signs

  From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcomes (1)

• Second Drug for Withdrawal

  From date of randomization until the date of last opioid dose or date of death from any cause or date of discharge, whichever came first, assessed up to 12 months

Study Arms (2)

methadone

ACTIVE COMPARATOR

Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide: NAS Score Methadone 8-12 0.05 mg/kg/dose \>=13 0.1 mg/kg/dose 1. Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax) 2. Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently \<8 for 48 hours. 3. If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.

Drug: Methadone

morphine

ACTIVE COMPARATOR

Morphine (1 mg/mL) administered orally every 4 hours. The following is a dosing guide: NAS Score Morphine 8-12 0.05 mg/kg/dose \>=13 0.1 mg/kg/dose 1. Maximum dose of morphine will be 0.2 mg/kg/dose. (NeoFax) 2. Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 6 hours, until NAS scores are consistently \<8 for 48 hours. 3. If the maximum dose of morphine is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.

Drug: Morphine

Interventions

Methadone DRUG

To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.

Also known as: see arm/group descriptions

methadone

Morphine DRUG

To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.

Also known as: see arm/group descriptions

morphine

Eligibility Criteria

• Age: 2 Hours - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• i. Evidence of opioid withdrawal clinically defined by at least 2 NAS scores \> 8 in an 8 hour time period, AND
• ii. Gestation =\> 35 weeks at entry defined by best obstetrical and physical exam criteria, AND
• iii. Medically stable condition in the opinion of the attending neonatologist, other than opiate withdrawal, AND
• iv. Mother on opiate replacement treatment therapy - methadone or buprenorphine.

You may not qualify if:

• i. Gestation \< 35 weeks at entry defined by best obstetrical and physical exam criteria.
• ii. Hypoglycemia, hypomagnesaemia, or hypocalcemia until corrected,
• iii. Serious medical illness such as sepsis, pneumonia, thyroid dysfunction, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU.
• iv. Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course
• v. Mother consistently taking prescribed benzodiazepine at the time of delivery

Sponsors & Collaborators

• Eastern Maine Medical Center: lead

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Methadone; Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; 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

Results Point of Contact

• Title: Dr. Mark Brown
• Organization: Eastern Maine Medical Center

mbrown@emh.org

207-973-9503

Study Officials

• Mark Brown, MD

  Eastern Maine Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pediatric Service, Neonatalogy

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: March 5, 2013
• Study Start: January 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 28, 2017
• Results First Posted: August 30, 2017

Record last verified: 2017-08