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Can Ondansetron Prevent Neonatal Abstinence Syndrome (NAS) in Babies Born to Narcotic-dependent Women (AIM2NAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Stanford University
Sponsor:
Collaborators:
Santa Clara Valley Medical Center
University of California, San Francisco
Information provided by (Responsible Party):
David R. Drover, Stanford University
ClinicalTrials.gov Identifier:
NCT01965704
First received: October 15, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

The Investigators hope to learn if they can prevent or lessen the symptoms of neonatal abstinence syndrome (NAS) in babies born to narcotic-dependent mothers by using the drug ondansetron in the mothers prior to delivery and their babies after delivery.

The study is a randomized, double-blind, placebo-controlled study with one half the mother-baby pairs to receive ondansetron and the other half of the mother-baby pairs to receive placebo. The pregnant narcotic-dependent mothers will receive an intravenous dose of study medication prior to delivery; the neonates, after their birth, will receive the same study medication the mother received every 24 hours for up to 5 days.

The Investigators will follow up with the mother-baby pairs for 10 days after study drug has stopped and one last follow up, about 30 days after stopping study drug, to learn if the baby had any symptoms of NAS in that time period.


Condition Intervention Phase
Narcotic Addiction
Neonatal Abstinence Syndrome
Drug: Ondansetron
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: AIM 2- Prevention of Neonatal Abstinence Syndrome

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Incidence of neonatal abstinence syndrome [ Time Frame: 35 days ] [ Designated as safety issue: No ]
    The incidence of neonatal abstinence syndrome (NAS) will be measured by the need for pharmacologic treatment for the symptoms of NAS while the neonates are receiving study medication and for the 30 days after stopping the study medication.


Secondary Outcome Measures:
  • Severity of neonatal abstinence syndrome [ Time Frame: 35 days ] [ Designated as safety issue: No ]
    Severity of NAS will be measured by: the length of hospital stay (birth to discharge); the total dose of narcotic required to treat the symptoms of NAS; and the need to include barbiturates in the treatment of the symptoms of NAS.


Estimated Enrollment: 90
Study Start Date: December 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ondansetron
Pregnant Women: ondansetron 8mg intravenously (IV) within 4 hours of delivery. Neonates: ondansetron 0.07 mg/kg given orally every 24 hours starting 4-8 hours after delivery, for up to 5 days (if IV line available in neonate, ondansetron 0.04 mg/kg IV every 24 hours for up to 5 days).
Drug: Ondansetron
Pregnant women may receive a second dose of IV ondansetron if they have not delivered within 4 hours of receiving the IV study medication. 50% of the 90 mother/baby pairs will receive ondansetron; the baby will always get the same study medication as the mother.
Other Name: Zofran
Placebo Comparator: Placebo

Pregnant Women: placebo given intravenously prior to delivery (volume to mimic the IV volume of the ondansetron group).

Neonates: placebo given orally every 24 hours, starting 4-8 hours after delivery, for up to 5 days with volume to mimic the oral volume of the ondansetron group (if IV line available, placebo may be given IV).

Drug: Placebo
All doses of placebo, whether IV or oral, will mimic the same volume as the ondansetron group to maintain the blind. Pregnant women may receive a second dose of IV placebo if they have not delivered within 4 hours of being given the IV study medication. 50% of the 90 mother/baby pairs will receive placebo; the baby will always receive the same study medication as the mother.
Other Name: IV Normal saline; oral simple syrup

Detailed Description:

All neonates will have a screening 12-lead EKG prior to their first dose of study medication to determine if QTc prolongation is present. A repeat 12-lead EKG will be done after each dose of study medication, approximately 2-5 hours post dose; if a neonate has prolonged QTc the study drug will be stopped.

Investigators may obtain up to 9 pharmacokinetic (PK) blood samples from the neonates over 5 days when standard of care blood samples are drawn. These samples will consist of 1 to 2 drops of blood collected on filter paper and sent to Stanford for PK analysis.

The modified Finnegan scoring system will be used to evaluate neonates for symptoms of NAS at each site and it is considered standard-of-care for babies at risk of NAS. Morphine will be the first treatment choice before other treatment medication choices (opioid or non-opioid) for NAS symptoms. Each site involved has established guidelines for starting, advancing and weaning treatment for NAS. Any medication used to treat NAS will be recorded.

Interim analysis: will be performed after the first 20 pregnant women and their neonates have been enrolled and dosed with study drug.

To protect the confidentiality of the patients (study subjects), the lead site, Stanford University, received a Certificate of Confidentiality from the NIH.

  Eligibility

Ages Eligible for Study:   up to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult female, pregnant with one fetus
  • adult female, opioid-dependent for at least 3 weeks prior to delivery
  • adult female, otherwise healthy
  • adult female, age 18-45 years inclusive
  • adult female, signed consent to participate for self and neonate
  • neonate, gestational age 37 weeks through 41 weeks and 6 days at birth
  • neonate, corrected QT interval (QTc) from 12-lead electrocardiogram (ECG) less than or equal to 440 milliseconds (ms).

Exclusion Criteria:

  • adult female, pregnant with more than one fetus
  • adult female, not dependent on opioids for at least 3 weeks prior to delivery
  • adult female, generally not healthy
  • adult female, age 17 years or less or 46 years of age and older
  • adult female, unwilling to sign consent for self or neonate
  • neonate, preterm or post-term gestational age at delivery
  • neonate, QTc showing results greater than 440 ms.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965704

Contacts
Contact: Carol A Cohane, RN 650-736-8231 cohane@stanford.edu

Locations
United States, California
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Carol A Cohane, RN       cohane@stanford.edu   
Principal Investigator: David R Drover, MD         
Sponsors and Collaborators
Stanford University
Santa Clara Valley Medical Center
University of California, San Francisco
Investigators
Principal Investigator: David R Drover, MD Stanford University
  More Information

No publications provided

Responsible Party: David R. Drover, Associate Professor of Anesthesia, Stanford School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01965704     History of Changes
Other Study ID Numbers: Aim 2_RO1-HD-070795-01A1, NAS2
Study First Received: October 15, 2013
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Stanford University:
Narcotic addiction during pregnancy
Neonatal abstinence syndrome
NAS

Additional relevant MeSH terms:
Neonatal Abstinence Syndrome
Behavior, Addictive
Opioid-Related Disorders
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Narcotics
Ondansetron
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on August 20, 2014