Neonatal Abstinence Syndrome
Conditions
Keywords
Neonatal Abstinence Syndrome, buprenorphine, neonatal, opioid withdrawal
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).
Interventions
DRUGbuprenorphine
sublingual buprenorphine administered every 8 hours, titrated to control of abstinence symptoms
DRUGOral morphine solution
0.4 mg/kg/day morphine every 4 hours
Sponsors
National Institute on Drug Abuse (NIDA)
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sublingual Buprenorphine safety and tolerability in the neonate | Index hospitalization |
Secondary
| Measure | Time frame |
|---|---|
| Buprenorphine Pharmacokinetics | Index hospitalization |
| Efficacy: Length of treatment | Index hospitalization |
| Efficacy: Length of hospitalization | Index hospitalization |
Countries
United States
Outcome results
None listed