Methadone Levels in Breast Milk of Women Taking Methadone... | NCT00218010

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

NCT00218010

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 12, 2017Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Breast Feeding
Opioid-Related Disorders

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2000

Primary Completion Date

Aug 2005Actual

Completion Date

Sep 2005Actual

First Submitted Date

Sep 16, 2005

First Submission Date that Met QC Criteria

Sep 16, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Name	Class
Johns Hopkins University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Methadone maintained lactating women		Methadone maintained women who chose to breastfeed their infants provided breast milk and plasma samples for this study.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

lactating women

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lauren M. Jansson, MD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University (BPRU) Bayview Campus		Baltimore	Maryland	21224 6823	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14974702	Background	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.
18333767	Result	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.

ID	Term
D005247	Feeding Behavior
D001519	Behavior
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders