Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

NCT00521248 | Completed Phase 1 DMC

• 2 other identifiers: R21DA018207-01DPMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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").

Conditions

Neonatal Abstinence Syndrome

Keywords

Neonatal Abstinence Syndrome; buprenorphine; neonatal; opioid withdrawal

Outcome Measures

Primary Outcomes (1)

• Sublingual Buprenorphine safety and tolerability in the neonate

  Index hospitalization

Secondary Outcomes (3)

• Buprenorphine Pharmacokinetics

  Index hospitalization

• Efficacy: Length of treatment

  Index hospitalization

• Efficacy: Length of hospitalization

  Index hospitalization

Study Arms (2)

Oral morphine solution

ACTIVE COMPARATOR

Oral morphine solution

Drug: Oral morphine solution

Buprenorphine

EXPERIMENTAL

Sublingual buprenorphine

Drug: buprenorphine

Interventions

buprenorphine DRUG

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

Also known as: Buprenex (buprenorphine)

Buprenorphine

Oral morphine solution DRUG

0.4 mg/kg/day morphine every 4 hours

Also known as: morphine

Oral morphine solution

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 37 weeks gestation
• exposure to opiates in utero
• demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• 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.

  PMID: 18694901 RESULT

• 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.

  PMID: 20925688 RESULT

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Buprenorphine; Morphine

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Morphine Derivatives

Study Officials

• Walter K Kraft, MD, MS

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 27, 2007
• Study Start: April 1, 2004
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 12, 2017

Record last verified: 2009-12

Locations

US (1)