Clinical trial NCT00218010: Methadone Levels in Breast Milk of Women Taking Methadone for Opiate Addiction - 2
Official title: Breastfeeding Among Methadone Maintained Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Feeding
Opioid-Related Disorders
Keywords: methadone
lactation
breastfeeding
maternal opioid dependency
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Johns Hopkins University
First posted: 2005-09-22
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lactating women

Brief summary: Methadone is a drug that offers significant therapeutic benefits to opiate dependent women who are pregnant. Currently, it is the treatment of choice for this group of people. The purpose of this study is to determine the amount of methadone in the breast milk of women who are breastfeeding and taking methadone for opiate addiction. In addition, this study will evaluate the effects of methadone on infant neurobehavior.

Detailed description: Methadone is a drug that is commonly used to treat opiate addiction, usually as part of a detoxification and maintenance program. Methadone offers significant therapeutic benefits to pregnant women who are opiate dependent, and it is currently the treatment of choice for this group of people. In general, breast milk is beneficial for infants. However, there is some concern as to whether it is safe for women who are taking methadone to breastfeed their babies. The purpose of this study is to determine the amount of methadone in the breast milk of women who are breastfeeding and taking methadone for opiate addiction. In addition, this study will evaluate the effects of methadone on infant neurobehavior.

Participants will be assigned to one of two groups: women taking methadone who will breastfeed their babies or women taking methadone who will bottle-feed their babies. On Days 1, 2, 3, 4, 14, and 30, following infant delivery, plasma will be collected from both groups and breast milk will be collected from the breastfeeding group. These samples will be quantitatively analyzed for methadone. Infants will undergo neurobehavioral assessments on Days 3, 14, and 30, following birth. Rates and severity of neonatal abstinence syndrome will also be evaluated.

Eligibility criteria: Inclusion Criteria:

* Generally healthy methadone-maintained women electing to either exclusively breastfeed or bottle-feed their infants for 1 month after delivery

Exclusion Criteria:

* Relapse to illicit drugs or alcohol at any time during the study
* Positive maternal or infant urine toxicology test at birth
* Serious medical or psychiatric illness requiring medication or medical intervention
* HIV infected
* Currently dependent on alcohol
* Major birth defect in the infant
* Significant medical problems in the infant, including premature birth, sepsis, or other infections

Primary outcomes:
measure: methadone concentrations in breast milk
timeFrame: 1-30 days after delivery
measure: methadone concentrations in maternal plasma
timeFrame: 1-30 days after delivery
Secondary outcomes:
measure: methadone concentrations in infant plasma
timeFrame: 1-30 days after delivery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University (BPRU) Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lauren M. Jansson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jansson LM, Velez M, Harrow C. Methadone maintenance and lactation: a review of the literature and current management guidelines. J Hum Lact. 2004 Feb;20(1):62-71. doi: 10.1177/0890334403261027.
citation: Jansson LM, Choo R, Velez ML, Lowe R, Huestis MA. Methadone maintenance and long-term lactation. Breastfeed Med. 2008 Mar;3(1):34-7. doi: 10.1089/bfm.2007.0032.
citation: Jansson LM, Choo R, Velez ML, Harrow C, Schroeder JR, Shakleya DM, Huestis MA. Methadone maintenance and breastfeeding in the neonatal period. Pediatrics. 2008 Jan;121(1):106-14. doi: 10.1542/peds.2007-1182.
citation: Jansson LM, Choo RE, Harrow C, Velez M, Schroeder JR, Lowe R, Huestis MA. Concentrations of methadone in breast milk and plasma in the immediate perinatal period. J Hum Lact. 2007 May;23(2):184-90. doi: 10.1177/0890334407300336.