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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00894452

Acronym

METHADOSE

Enrollment

210

Registered

2009-05-07

Start date

2008-12-31

Completion date

2013-05-31

Last updated

2016-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heroin Dependence

Keywords

Methadone, CYP, OPRM1, MDR1, COMT, Midazolam challenge

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Functional activity CYP3A4	Day15	Functional activity CYP3A4 as measured by the ratio of metabolite / parent drug provided by the functional test the oral midazolam.

Countries

France

Outcome results