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Variance of Oral Methadone Dosage: Description of Implicated Factors (METHADOSE)

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ClinicalTrials.gov Identifier: NCT00894452
Recruitment Status : Completed
First Posted : May 7, 2009
Last Update Posted : September 29, 2016
Information provided by (Responsible Party):
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.

Condition or disease
Heroin Dependence

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 Type : Observational
Actual Enrollment : 210 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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 Start Date : December 2008
Primary Completion Date : April 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin
U.S. FDA Resources

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA

serum: orosomucoid, methadone dosage, OH midazolam/midazola ratio


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Defined population: participants or population are selected based on predefined 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894452

hospital Lariboisière-Fernand-WidalCity: PARIS
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Florence VORSPAN, MD Assistance Publique - Hôpitaux de Paris


Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00894452     History of Changes
Other Study ID Numbers: P070603
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Midazolam challenge

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents