Clinical trial NCT00521248: Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Official title: Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neonatal Abstinence Syndrome
Keywords: Neonatal Abstinence Syndrome
buprenorphine
neonatal
opioid withdrawal
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-08-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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").


Eligibility 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

Primary outcomes:
measure: Sublingual Buprenorphine safety and tolerability in the neonate
timeFrame: Index hospitalization
Secondary outcomes:
measure: Buprenorphine Pharmacokinetics
timeFrame: Index hospitalization
measure: Efficacy: Length of treatment
timeFrame: Index hospitalization
measure: Efficacy: Length of hospitalization
timeFrame: Index hospitalization
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Walter K Kraft, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kraft WK, Gibson E, Dysart K, Damle VS, Larusso JL, Greenspan JS, Moody DE, Kaltenbach K, Ehrlich ME. Sublingual buprenorphine for treatment of neonatal abstinence syndrome: a randomized trial. Pediatrics. 2008 Sep;122(3):e601-7. doi: 10.1542/peds.2008-0571. Epub 2008 Aug 11.
citation: Kraft WK, Dysart K, Greenspan JS, Gibson E, Kaltenbach K, Ehrlich ME. Revised dose schema of sublingual buprenorphine in the treatment of the neonatal opioid abstinence syndrome. Addiction. 2011 Mar;106(3):574-80. doi: 10.1111/j.1360-0443.2010.03170.x. Epub 2010 Oct 6.