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Treatment of Neonatal Abstinence Syndrome (HOMENOW)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01723722
First Posted: November 8, 2012
Last Update Posted: November 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark S Brown, MD, Eastern Maine Medical Center
  Purpose
This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment. This is a randomized, open-label comparison of phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.

Condition Intervention Phase
Neonatal Abstinence Syndrome Drug: Methadone Drug: Diluted Deodorized Tincture of Opium Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Neonatal Abstinence Syndrome: Evaluation of Efficacy of Phenobarbital in Combination With Either Methadone or Diluted Deodorized Tincture of Opium as Stabilizing and Tapering Regiments

Resource links provided by NLM:


Further study details as provided by Mark S Brown, MD, Eastern Maine Medical Center:

Primary Outcome Measures:
  • Length of Treatment With Opioid Medication [ Time Frame: Up to 12 months ]
    Up to 12 months


Enrollment: 40
Study Start Date: January 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 (Phenobarbital and Methadone)

The following is a dosing guide for methadone:

  1. The neonatal concentration is 1 mg/ml of methadone. It is administered orally every 12 hours.
  2. For the first 24 hours, doses will be prescribed every 6 hours using a sliding scale in response to the last NAS score:

    NAS Score Methadone dose 8-11 0.05 mg/kg/dose 12-15 0.1 mg/kg/dose

    ≥16 0.15 mg/kg/dose

  3. Maximum dose of methadone will be 0.15 mg/kg/dose.
  4. After the first 24 hours of treatment, the total methadone dose will be summed and that dose divided into two doses, given 12 hours apart. For the following 24 hours, additional doses may be given every 6 hours as needed and added to the next 24 hour's doses divided every 12 hours, until NAS scores are consistently <8 for 48 hours.
  5. If at any pointthe maximum dose of methadone is reached and withdrawal is not controlled, then in the opinion of two neonatologists the patient can be crossed-over to the dDTO arm.
Drug: Methadone
Concentration is 1mg/mL administered every 12 hours given on sliding scale in response to last NAS score.
Other Name: Dolophine
Active Comparator: 2 (Phenobarbital and Diluted Deodorized Tincture of Opium)

The following is a dosing guide for dDTO:

  1. The neonatal concentration is 1:24 dilution for a concentration of 0.4%, equivalent to 0.4 mg/ml of morphine. It is administered orally every 4 hours.
  2. The starting dose will be determined using a sliding scale in response to the last NAS score before starting.

    NAS Score Starting dDTO dose 8-11 0.4 mg/kg/day 12-15 0.6 mg/kg/day

    ≥16 0.8 mg/kg/day

  3. The maximum dose of DTO will be 0.8 mg/kg/day.
  4. After the first 24 hours of treatment, if the NAS scores are still ≥8, the dose will be increased to the next level.
  5. If at any point the maximum dose of methadone is reached and withdrawal is not controlled, then in the opinion of two neonatologists the patient can be crossed-over to the methadone arm.
Drug: Diluted Deodorized Tincture of Opium
Concentration is 1:24 dilution for a concentration of 0.4%
Other Name: Laudanum

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   up to 6 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Evidence of opioid withdrawal clinically as defined by 2 NAS scores >8 or 1 NAS score >12 over a 4 to 8 hour time period, AND
  • Gestation >=35 weeks at entry defined by best obstetrical and physical exam criteria, AND
  • Medically stable condition, other than in opioid withdrawal, in the opinion of the attending neonatologist, AND EITHER,
  • Meconium or urine drug screen positive for opioids on mother or newborn, OR
  • Known maternal prescription of opioids for chronic pain management during at least the last trimester of pregnancy, OR
  • Known maternal prescription of opioids for treatment of addiction, OR
  • Suspected or admitted abuse with opioid drugs
  • Infants of mothers with a medical or psychiatric diagnosis will not be excluded, unless the maternal diagnosis precludes informed consent

Exclusion Criteria:

  • Gestation <35 weeks at entry defined by best obstetrical and physical exam criteria.
  • Hypoglycemia, hypomagnesaemia, or hypocalcaemia until corrected.
  • Serious medical illness such as sepsis, pneumonia, hyperthyroidism, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU.
  • Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723722


Locations
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Sponsors and Collaborators
Eastern Maine Medical Center
Investigators
Principal Investigator: Mark S. Brown, MD Eastern Maine Medical Center
  More Information

Responsible Party: Mark S Brown, MD, Chief of Pediatric Service, Neonatalogy, Eastern Maine Medical Center
ClinicalTrials.gov Identifier: NCT01723722     History of Changes
Other Study ID Numbers: 07-2-M-107
First Submitted: January 27, 2011
First Posted: November 8, 2012
Results First Submitted: March 1, 2013
Results First Posted: November 27, 2013
Last Update Posted: November 27, 2013
Last Verified: November 2013

Keywords provided by Mark S Brown, MD, Eastern Maine Medical Center:
Neonatal Abstinence Syndrome
Methadone
Diluted Deodorized Tincture of Opium
dDTO
Phenobarbital

Additional relevant MeSH terms:
Syndrome
Neonatal Abstinence Syndrome
Disease
Pathologic Processes
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Opium
Phenobarbital
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Anticonvulsants
Hypnotics and Sedatives
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers