Trial Outcomes & Findings for Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal (NCT NCT01804075)

Results Overview

The length of time in days that the treatment opioid was used on a measured taper to ameliorate withdrawal signs

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months

Results posted on

2017-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Methadone Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide: NAS Score Methadone 8-12 0.05 mg/kg/dose \>=13 0.1 mg/kg/dose 1. Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax) 2. Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently \<8 for 48 hours. 3. If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment. Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.	Morphine Morphine (1 mg/mL) administered orally every 4 hours. The following is a dosing guide: NAS Score Morphine 8-12 0.05 mg/kg/dose \>=13 0.1 mg/kg/dose 1. Maximum dose of morphine will be 0.2 mg/kg/dose. (NeoFax) 2. Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 6 hours, until NAS scores are consistently \<8 for 48 hours. 3. If the maximum dose of morphine is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment. Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.
Overall Study STARTED	15	16
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Morphine Treated n=16 Participants infants randomized to receive morphine as their primary treatment for withdrawal	Methadone Treated n=15 Participants infants randomized to receive methadone as their primary treatment for withdrawal	Total n=31 Participants Total of all reporting groups
Age, Continuous	2.1 days STANDARD_DEVIATION 1 • n=5 Participants	2.3 days STANDARD_DEVIATION 1.2 • n=7 Participants	2.2 days STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months

The length of time in days that the treatment opioid was used on a measured taper to ameliorate withdrawal signs

Outcome measures

Outcome measures
Measure	Methadone-treated n=15 Participants group of infants randomized to receive methadone treatment for their withdrawal	Morphine-treated n=16 Participants Group randomized to receive morphine treatment for their withdrawal
Days of Treatment With Opioid Medication	13.9 days Standard Deviation 4.6	22.9 days Standard Deviation 9.7

SECONDARY outcome

Timeframe: From date of randomization until the date of last opioid dose or date of death from any cause or date of discharge, whichever came first, assessed up to 12 months

Number of infants treated with a second drug to treat their withdrawal

Outcome measures

Outcome measures
Measure	Methadone-treated n=15 Participants group of infants randomized to receive methadone treatment for their withdrawal	Morphine-treated n=16 Participants Group randomized to receive morphine treatment for their withdrawal
Second Drug for Withdrawal	5 Participants	9 Participants

Adverse Events

Methadone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Morphine

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 Brown

Eastern Maine Medical Center

Phone: 207-973-9503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place