Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Information source: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neonatal Abstinence Syndrome
Intervention: buprenorphine (Drug); Oral morphine solution (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Thomas Jefferson University Official(s) and/or principal investigator(s): Walter K Kraft, MD, MS, Principal Investigator, Affiliation: Thomas Jefferson University
Summary
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").
Clinical Details
Official title: Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Sublingual Buprenorphine safety and tolerability in the neonate
Secondary outcome: Buprenorphine PharmacokineticsEfficacy: Length of treatment Efficacy: Length of hospitalization
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107, United States
Additional Information
Starting date: April 2004
Last updated: October 20, 2011
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