Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Variance of Oral Methadone Dosage: Description of Implicated Factors (METHADOSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00894452
First received: March 31, 2009
Last updated: January 20, 2015
Last verified: January 2015

March 31, 2009
January 20, 2015
December 2008
April 2013   (final data collection date for primary outcome measure)
Functional activity CYP3A4 [ Time Frame: Day15 ] [ Designated as safety issue: No ]
Functional activity CYP3A4 as measured by the ratio of metabolite / parent drug provided by the functional test the oral midazolam.
Not Provided
Complete list of historical versions of study NCT00894452 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Variance of Oral Methadone Dosage: Description of Implicated Factors
Factors Associated With the Variance of Oral Methadone Dosage at Steady State of Maintenance Treatment: Description of Bio-markers of Phenotype and Genotype.

The purpose of this study is to describe clinical, pharmacokinetic and genetic factors associated with the variance of oral methadone dosage for patients at the steady state of heroin dependence maintenance treatment. The hypothesis is that the investigators can predict 70% of the variance with few factors, including CYP 3A4 function measured with oral midazolam challenge.

Patients at the steady state of methadone maintenance treatment may receive oral dosage ranging from 5 to 130 mg per day in our clinical practice. This study is aimed at providing a comprehensive cross-sectional description of factors involved in this variance:

  • comorbidity with addictive and psychiatric disorders
  • severity of pre-existing heroin dependence
  • function of CYP 3A4 enzyme assessed with oral midazolam challenge
  • genetic polymorphisms of enzymes implicated in methadone pharmacokinetic and pharmacodynamic (CYPs, MDR1, OPRM1, COMT)

The expected result is a predictive equation of oral methadone dosage at steady state.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

serum: orosomucoid, methadone dosage, OH midazolam/midazola ratio

DNA: CYPs, MDR1, OPRM1, COMT

Non-Probability Sample

Defined population: participants or population are selected based on predefined criteria

Heroin Dependence
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
May 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • heroin dependence
  • under maintenance treatment with methadone
  • at steady state: stable oral methadone dosage since 3 months at least

Exclusion Criteria:

  • current heroin dependence or abuse
  • current cocaine and/or alcohol and/or sedatives dependence
  • pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00894452
P070603
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Florence VORSPAN, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP