Clinical Trial: Variance of Oral Methadone Dosage: Description of Implicated Factors

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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.

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 Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: March 31, 2009
Date Started: December 2008
Date Completion:
Last Updated: September 28, 2016
Last Verified: September 2016