Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Study Overview
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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).

Official Title
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Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Conditions
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Neonatal Abstinence Syndrome

Intervention / Treatment
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* Drug: buprenorphine
* Drug: Oral morphine solution


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral morphine solution<br>Oral morphine solution | Drug: Oral morphine solution<br>* 0.4 mg/kg/day morphine every 4 hours<br>* Other names: morphine;|
| Experimental: Buprenorphine<br>Sublingual buprenorphine | Drug: buprenorphine<br>* sublingual buprenorphine administered every 8 hours, titrated to control of abstinence symptoms<br>* Other names: Buprenex (buprenorphine);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sublingual Buprenorphine safety and tolerability in the neonate |  | Index hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Buprenorphine Pharmacokinetics |  | Index hospitalization | 
| Efficacy: Length of treatment |  | Index hospitalization | 
| Efficacy: Length of hospitalization |  | Index hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal Abstinence Syndrome, buprenorphine, neonatal, opioid withdrawal