Interest of Concentrations in Meconium of Buprenorphine and Methadone as a Prognostic Factor of NAS Outcome (SUBOPGEST)

November 3, 2017 updated by: University Hospital, Caen

Interest of Concentrations in Meconium of Drugs Used for Treatment of Pregnant Opioid-dependent Woman as a Prognostic Factor of Time, Severity and Duration of Neonatal Abstinence Syndrome

The aim of this study is to characterize the interest of concentrations in meconium of drugs used for treatment of pregnant opioid-dependent woman as a prognostic factor of time, severity and duration of neonatal abstinence syndrome (NAS). 43 women treated with buprenorphine, 49 with methadone, and their newborns, were included. NAS is assessed by Lipsitz scale. Buprenorphine, norbuprenorphine, methadone, EDDP and morphine are quantified in meconium (one collected immediately after birth, another for 24 to 48 h) by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, developed and validated for this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • CAEN university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Newborns and mothers under opioid replacement therapy during pregnancy

Description

Inclusion Criteria:

  • Aged over 18 years
  • pregnant women
  • Having agreed to participate in the study after information
  • Under opioid replacement therapy during pregnancy, in combination or not with other psychotropic drugs or legal or illegal substances.
  • Delivery after more than 34 weeks of amenorrhea

Exclusion Criteria:

  • Pregnant women not receiving substitution treatment (methadone or buprenorphine).
  • Patient under substitution treatment delivering before 34 weeks of amenorrhea
  • Patient aged under 18 yrs old
  • Patient unable to understand the study (mental deficiency, impairment of consciousness, not French) or not accepting to answer the questionnaires.
  • Severe malformation syndrome or chromosomal abnormality in newborn discovered during pregnancy.
  • mother's death or newborn's death

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
exposed mother and child
mother and child who have been exposed to methadone or to buprenorphine during pregnancy
Procedure: Concentrations in Meconium of Buprenorphine and Methadone
buprenorphine or methadone concentration measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
meconium concentration of buprenorphine
Time Frame: variation over time at baseline and 24hrs to 48hrs after birth
variation over time at baseline and 24hrs to 48hrs after birth
meconium concentration of methadone
Time Frame: variation over time at baseline and 24hrs to 48hrs after birth
variation over time at baseline and 24hrs to 48hrs after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urine concentration of buprenorphine or methadone
Time Frame: baseline and 24hrs to 48hrs after birth
baseline and 24hrs to 48hrs after birth
by the score of Lipsitz,
Time Frame: 4 times a day when the newborn is awake from baseline to 48hrs
Clinical evaluation of the newborn
4 times a day when the newborn is awake from baseline to 48hrs
screening of other drugs in mother's urine and meconium
Time Frame: baseline and 24hrs to 48hrs after birth
baseline and 24hrs to 48hrs after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

November 3, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 3, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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