Variance of Oral Methadone Dosage: Description of Implicated Factors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heroin Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

hospital Lariboisière-Fernand-WidalCity: PARIS

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Functional activity CYP3A4

Time frame: Day15

Functional activity CYP3A4 as measured by the ratio of metabolite / parent drug provided by the functional test the oral midazolam.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: METHADOSE

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: May 7, 2009
Registry last updated: Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed