Variance of Oral Methadone Dosage: Description of Implicated Factors

Completed

• Conditions: Heroin Dependence

• Registration Number: NCT00894452
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-05-06
• Study First Posted: 2009-05-07
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

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

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Exclusion Criteria

• current heroin dependence or abuse
• current cocaine and/or alcohol and/or sedatives dependence
• pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

hospital Lariboisière-Fernand-WidalCity: PARIS; 🇫🇷 Paris, France