Trial Outcomes & Findings for A Study of Breastfeeding in Buprenorphine Maintained Women (NCT NCT01806389)

NCT ID: NCT01806389

Last Updated: 2017-06-15

Results Overview

Maternal plasma will be obtained at the time of peak buprenorphine levels on days 2,3,4,14 and 30

• Recruitment status: COMPLETED
• Target enrollment: 10 participants
• Primary outcome timeframe: Days 2,3,4,14 and 30 after delivery
• Results posted on: 2017-06-15

Participant Flow

Subjects were recruited from a study evaluating fetal and infant effects of maternal buprenorphine treatment

Fourteen women were consented for this protocol but 4 were withdrawn for various reasons, i.e. inability to provide samples, changed mind about breastfeeding.

Participant milestones

Measure	Buprenorphine Maintained Lactating Women Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria
Overall Study STARTED	14
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Buprenorphine Maintained Lactating Women Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria
Overall Study Withdrawal by Subject	4

Baseline Characteristics

A Study of Breastfeeding in Buprenorphine Maintained Women

Baseline characteristics by cohort

Measure	Buprenorphine Maintained Lactating Women n=10 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	26.1 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Days 2,3,4,14 and 30 after delivery

Maternal plasma will be obtained at the time of peak buprenorphine levels on days 2,3,4,14 and 30

Outcome measures

Measure	PLASMA Buprenorphine Maintained Lactating Women Day 2 n=10 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 2	PLASMA Buprenorphine Maintained Lactating Women Day 3 n=10 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 3	PLASMA Buprenorphine Maintained Lactating Women Day 4 n=9 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 4	PLASMA Buprenorphine Maintained Lactating Women Day 14 n=9 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 14	PLASMA Buprenorphine Maintained Lactating Women Day 30 n=8 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 30
Maternal Plasma Concentrations of Buprenorphine	1.2 ug/mL Interval 0.4 to 6.1	1.7 ug/mL Interval 0.7 to 7.0	2.0 ug/mL Interval 0.5 to 5.9	2.4 ug/mL Interval 0.7 to 3.3	2.2 ug/mL Interval 1.2 to 6.1

PRIMARY outcome

Timeframe: Days 2,3,4,14 and 30 after delivery

Breast milk will be obtained on these days at the time of peak plasma levels of buprenoprhine

Outcome measures

Measure	PLASMA Buprenorphine Maintained Lactating Women Day 2 n=10 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 2	PLASMA Buprenorphine Maintained Lactating Women Day 3 n=10 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 3	PLASMA Buprenorphine Maintained Lactating Women Day 4 n=8 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 4	PLASMA Buprenorphine Maintained Lactating Women Day 14 n=9 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 14	PLASMA Buprenorphine Maintained Lactating Women Day 30 n=7 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 30
Maternal Breast Milk Concentrations of Buprenorphine	2.3 ug/mL Interval 0.2 to 4.2	1.5 ug/mL Interval 0.2 to 5.0	1.4 ug/mL Interval 0.3 to 5.2	4.8 ug/mL Interval 1.0 to 10.5	3.3 ug/mL Interval 2.2 to 20.8

PRIMARY outcome

Timeframe: Day 14 of life

Infant plasma concentrations of buprenoprhine obtained on day 14 of life

Outcome measures

Measure	PLASMA Buprenorphine Maintained Lactating Women Day 2 n=9 Participants Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 2	PLASMA Buprenorphine Maintained Lactating Women Day 3 Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 3	PLASMA Buprenorphine Maintained Lactating Women Day 4 Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 4	PLASMA Buprenorphine Maintained Lactating Women Day 14 Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 14	PLASMA Buprenorphine Maintained Lactating Women Day 30 Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 30
Infant Plasma Concentrations of Buprenorphine	0 ug/mL Interval 0.0 to 2.9	—	—	—	—

Adverse Events

Buprenorphine

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. Lauren Jansson

Johns Hopkins University School of Medicine

Phone: 410-550-5438

Email: ljansson@jhmi.edu

Results disclosure agreements

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