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

Opioid-Related Disorders Clinical Trial

Official title:

Breastfeeding Among Methadone Maintained Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218010
• Other study ID #: NIDA-00495-2
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: January 11, 2017
• Start date: November 2000
• Est. completion date: September 2005

Study information

• Verified date: April 2015
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Feeding
• Opioid-Related Disorders

Locations

Country	Name	City	State
United States	Johns Hopkins University (BPRU) Bayview Campus	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	methadone concentrations in breast milk		1-30 days after delivery	No
Primary	methadone concentrations in maternal plasma		1-30 days after delivery	No
Secondary	methadone concentrations in infant plasma		1-30 days after delivery	No