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Completed

NCT Number: NCT00521248

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual (under the tongue) buprenorphine is able to be used safely and easily in newborns with the neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine is associated shorter stays in the hospital and fewer days of treatment than the use of standard therapy. Another secondary goal will be to understand buprenorphine concentration in the blood of babies treated with the drug (this is called "pharmacokinetics").

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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

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 opiates in utero
  • demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment

Exclusion criteria

  • major congenital malformations and/or intrauterine growth retardation
  • medical illness requiring intensification of medical therapy
  • concomitant benzodiazepine or severe alcohol abuse, self-report of regular use of alcohol or of benzodiazepines use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother during pregnancy,
  • concomitant use of CYP 3A inhibitors (erythromycin, clarithromycin, ketoconazole, itraconazole, HIV protease inhibitors) or inducers (rifampin, carbamazepine, phenobarbital) prior to initiation of NAS treatment
  • seizure activity or other neurologic abnormality
  • breast feeding
  • inability of mother to give informed consent due to co-morbid psychiatric diagnosis
  • hypoglycemia requiring treatment with intravenous glucose

Treatment and study plan

buprenorphine

Drug

sublingual buprenorphine administered every 8 hours, titrated to control of abstinence symptoms

Other names: Buprenex (buprenorphine)

Oral morphine solution

Drug

0.4 mg/kg/day morphine every 4 hours

Other names: morphine

Primary outcomes

  1. Sublingual Buprenorphine safety and tolerability in the neonate

    Time frame: Index hospitalization

Secondary outcomes

  1. Buprenorphine Pharmacokinetics

    Time frame: Index hospitalization

  2. Efficacy: Length of treatment

    Time frame: Index hospitalization

  3. Efficacy: Length of hospitalization

    Time frame: Index hospitalization

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Aug 27, 2007
Registry last updated
Jan 12, 2017

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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