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

NCT ID: NCT00218010

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2005-09-30

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.

Conditions

Breast Feeding; Opioid-Related Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Methadone maintained lactating women

Methadone maintained women who chose to breastfeed their infants provided breast milk and plasma samples for this study.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren M. Jansson, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University (BPRU) Bayview Campus

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 14974702 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18333767 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18166563 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17478871 (View on PubMed)

Other Identifiers

NIDA-00495-2

Identifier Type: -

Identifier Source: org_study_id