Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines

NCT ID: NCT01671410

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-09-30

Brief Summary

The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.

Detailed Description

Infants with in utero exposure to opioids often require therapy with morphine for an extended period. In a clinical trial, sublingual buprenorphine reduced this treatment period by ~30%. However, infants with both opioid and benzodiazepine exposure were not included in the trial. This study will test the safety and tolerability of sublingual buprenorphine in infants with in utero exposure to benzodiazepines or who are breastfeeding.

Conditions

Neonatal Abstinence Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sublingual buprenorphine

Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose

Group Type: EXPERIMENTAL

sublingual buprenorphine

Intervention Type: DRUG

Sublingual buprenorphine for the treatment of neonatal abstinence syndrome

oral morphine

Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours

Group Type: ACTIVE_COMPARATOR

oral morphine

Intervention Type: DRUG

Oral morphine for the treatment of neonatal abstinence syndrome

Interventions

oral morphine

Oral morphine for the treatment of neonatal abstinence syndrome

Intervention Type: DRUG

sublingual buprenorphine

Sublingual buprenorphine for the treatment of neonatal abstinence syndrome

Intervention Type: DRUG

Other Intervention Names

morphine; buprenex

Eligibility Criteria

Inclusion Criteria

1. ≥ 37 weeks gestation

2. Exposure to opioids in utero

3. Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment

4. Exposure to benzodiazepines in utero and/or receiving breast milk. Benzodiazepine use is defined as maternal use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth.

Exclusion Criteria

1. Major congenital malformations and/or intrauterine growth retardation defined as birth weight <2200 gm

2. Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.

3. Hypoglycemia requiring treatment with intravenous dextrose

4. Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)

5. Seizure activity or other neurologic abnormality

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter K Kraft, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

12D.398

Identifier Type: -

Identifier Source: org_study_id