Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Thomas Jefferson University

Status and phase: Completed; Phase 1

Conditions: Neonatal Abstinence Syndrome

Treatments: Drug: Oral morphine solution; Drug: buprenorphine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00521248

R21DA018207-01 (U.S. NIH Grant/Contract)

DPMC

Details and patient eligibility

About

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").

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Oral morphine solution

Active Comparator group

Description:

Oral morphine solution

Treatment:

Drug: Oral morphine solution

Buprenorphine

Experimental group

Description:

Sublingual buprenorphine

Treatment:

Drug: buprenorphine