Methadone Levels in Breast Milk of Women Taking Methadone for Opiate Addiction - 2

Breastfeeding Among Methadone Maintained Women

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.

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders; Breast Feeding

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224 6823
      • Johns Hopkins University (BPRU) Bayview Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

lactating women

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Methadone maintained lactating women; Methadone maintained women who chose to breastfeed their infants provided breast milk and plasma samples for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
methadone concentrations in breast milk	1-30 days after delivery
methadone concentrations in maternal plasma	1-30 days after delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
methadone concentrations in infant plasma	1-30 days after delivery

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Lauren M. Jansson, MD, Johns Hopkins University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2000
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: breastfeeding; lactation; methadone; maternal opioid dependency
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: NIDA-00495-2