Back to results

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Primary Purpose

Neonatal Abstinence Syndrome

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

buprenorphine

Oral morphine solution

About this trial

This is an interventional treatment trial for Neonatal Abstinence Syndrome focused on measuring Neonatal Abstinence Syndrome, buprenorphine, neonatal, opioid withdrawal

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oral morphine solution

Buprenorphine

Arm Description

Oral morphine solution

Sublingual buprenorphine

Outcomes

Primary Outcome Measures

Sublingual Buprenorphine safety and tolerability in the neonate

Secondary Outcome Measures

Buprenorphine Pharmacokinetics

Efficacy: Length of treatment

Efficacy: Length of hospitalization

Full Information

NCT ID

NCT00521248

First Posted

August 23, 2007

Last Updated

January 11, 2017

Sponsor

Thomas Jefferson University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00521248

Brief Title

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Official Title

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Thomas Jefferson University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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").

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neonatal Abstinence Syndrome

Keywords

Neonatal Abstinence Syndrome, buprenorphine, neonatal, opioid withdrawal

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral morphine solution

Arm Type

Active Comparator

Arm Description

Oral morphine solution

Arm Title

Buprenorphine

Arm Type

Experimental

Arm Description

Sublingual buprenorphine

Intervention Type

Drug

Intervention Name(s)

buprenorphine

Other Intervention Name(s)

Buprenex (buprenorphine)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oral morphine solution

Other Intervention Name(s)

morphine

Intervention Description

0.4 mg/kg/day morphine every 4 hours

Primary Outcome Measure Information:

Title

Sublingual Buprenorphine safety and tolerability in the neonate

Time Frame

Index hospitalization

Secondary Outcome Measure Information:

Title

Buprenorphine Pharmacokinetics

Time Frame

Index hospitalization

Title

Efficacy: Length of treatment

Time Frame

Index hospitalization

Title

Efficacy: Length of hospitalization

Time Frame

Index hospitalization

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walter K Kraft, MD, MS

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Jefferson University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18694901

Citation

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.

Results Reference

result

PubMed Identifier

20925688

Citation

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.

Results Reference

result

Learn more about this trial

Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

We'll reach out to this number within 24 hrs