Variance of Oral Methadone Dosage: Description of Implicated Factors
Information source: Assistance Publique - Hôpitaux 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 - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Florence VORSPAN, MD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 Lariboisière-Fernand-WidalCity: PARIS, Paris 75010, France
Additional Information
Starting date: December 2008
Last updated: January 20, 2015
|
