Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)
|ClinicalTrials.gov Identifier: NCT01708707|
Recruitment Status : Active, not recruiting
First Posted : October 17, 2012
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Abstinence Syndrome Neonatal Withdrawal Syndrome||Drug: Buprenorphine Drug: Morphine Sulfate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Comparison of Sublingual Buprenorphine to Morphine Sulfate in the Treatment of Neonatal Abstinence Syndrome (NAS)|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||April 2018|
Active Comparator: Oral morphine sulfate
Oral morphine sulfate 0.4 mg/kg/day morphine every 3-4 hours as needed for Finnegan scores suggestive of Neonatal Abstinence Syndrome Other Name: morphine
Drug: Morphine Sulfate
Oral Morphine Sulfate Dosage: Morphine Sulfate Oral Solution 100mg/5mL Initially dosed at 0.4mg/kg per day in six daily doses Duration of medication administration dependent upon infant symptoms of neonatal withdrawal, with mean duration of use at Banner Good Samaritan Hospital currently averaging 25 days.
Sublingual Buprenorphine 15.9 µg/kg per day in 3 divided doses, titrated up or escalated down based upon standardized scoring for neonatal abstinence syndrome
The injectable formulation of buprenorphine (Buprenex; Reckitt Benckiser) will be prepared to a final concentration of 0.075 mg/mL in 100% ethanol and simple syrup USP to create a sublingual preparation.
Infants initial dose: 15.9 µg/kg per day in 3 divided doses with escalation/weaning based upon standardized scoring of NAS symptoms, using standardized Finnegan scoring Maximum dosage: 60 µg/kg per day Duration: Infants will receive buprenorphine until they are successfully weaned off of opioids and no longer show withdrawal symptoms, evidenced by low Finnegan scores. Mean use in other investigations was 24 days.
- Hospital length of stay [ Time Frame: Up to hospital discharge, an anticipated average of 4 weeks ]Number of days of hospital admission
- Number of adverse or serious adverse events [ Time Frame: Up to hospital discharge, with length of stay currently averaging approximately 4 weeks ]
- Cost efficiency of buprenorphine [ Time Frame: At least 48 prior to hospital discharge, with anticipated discharge averaging to be 4 weeks ]Cost of buprenorphine as a product of number of days of administration
- Withdrawal symptoms [ Time Frame: Up to hospital discharge, usually occuring on average 4 weeks ]Finnegan methodology to score withdrawal symptoms every four hours of medication administration
- Rescue dosage administration [ Time Frame: Up to hospital discharge, anticipating an average of 4 weeks ]Number of rescue doses of additional medication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708707
|United States, Arizona|
|Banner - University Medical Center Phoenix|
|Phoenix, Arizona, United States, 85006|
|Principal Investigator:||Gregory Martin, MD||Banner - University Medical Center Phoenix|