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Variance of Oral Methadone Dosage: Description of Implicated Factors

Information source: Assistance Publique - H˘pitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heroin Dependence

Phase: N/A

Status: Completed

Sponsored by: Assistance Publique - H˘pitaux de Paris

Official(s) and/or principal investigator(s):
Florence VORSPAN, MD, Principal Investigator, Affiliation: Assistance Publique - H├┤pitaux de Paris


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.

Clinical Details

Official title: Factors Associated With the Variance of Oral Methadone Dosage at Steady State of Maintenance Treatment: Description of Bio-markers of Phenotype and Genotype.

Study design: Observational Model: Case-Only, Time Perspective: Cross-Sectional

Primary outcome: Functional activity CYP3A4

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

hospital Lariboisi├Ęre-Fernand-WidalCity: PARIS, Paris 75010, France
Additional Information

Starting date: December 2008
Last updated: January 20, 2015

Page last updated: August 23, 2015

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