Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2010-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Neonatal Abstinence Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral morphine solution

Group Type ACTIVE_COMPARATOR

Oral morphine solution

Intervention Type DRUG

0.4 mg/kg/day morphine every 4 hours

Buprenorphine

Sublingual buprenorphine

Group Type EXPERIMENTAL

buprenorphine

Intervention Type DRUG

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

Interventions

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buprenorphine

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

Intervention Type DRUG

Oral morphine solution

0.4 mg/kg/day morphine every 4 hours

Intervention Type DRUG

Other Intervention Names

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Buprenex (buprenorphine) morphine

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No