Trial Outcomes & Findings for Treatment of Neonatal Abstinence Syndrome (NCT NCT01723722)

NCT ID: NCT01723722

Last Updated: 2013-11-27

Results Overview

Up to 12 months

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2013-11-27

Participant Flow

Recruitment period 11/15/2007 through 9/1/2009; location Eastern Maine Medical Center NICU

Exclusion for other medical conditions causing withdrawal symptoms, gestation less than 35 weeks

Participant milestones

Measure	Methadone After Phenobarbital for Withdrawal for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone	Deodorized Tincture Opium After Phenobarbital for Withdrawal for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Neonatal Abstinence Syndrome

Baseline characteristics by cohort

Measure	Methadone After Phenobarbital for Withdrawal n=20 Participants for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone	DTO After Phenobarbital for Withdrawal n=20 Participants for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	0.005 years STANDARD_DEVIATION 0 • n=5 Participants	0.005 years STANDARD_DEVIATION 0 • n=7 Participants	0.005 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Completion of treatment

Up to 12 months

Outcome measures

Measure	Deodorized Tincture Opium After Phenobarbital for Withdrawal n=20 Participants for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium	Methadone After Phenobarbital for Withdrawal n=20 Participants for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
Length of Treatment With Opioid Medication	19.1 days Standard Deviation 8.8	17.7 days Standard Deviation 10

Adverse Events

Methadone After Phenobarbital for Withdrawal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DTO After Phenobarbital for Withdrawal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Mark S Brown

Eastern Maine Medical Center

Phone: 207-973-8670

Email: mbrown@emh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place