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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00894452
First received: March 31, 2009
Last updated: December 2, 2009
Last verified: April 2009
  Purpose

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
Heroin Dependence

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Biospecimen Retention:   Samples With DNA

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

DNA: CYPs, MDR1, OPRM1, COMT


Estimated Enrollment: 200
Study Start Date: December 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Defined population: participants or population are selected based on predefined criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894452

Contacts
Contact: Florence VORSPAN, MD 33-1-40 05 42 75 florence.vorspan@lrb.aphp.fr

Locations
France
hospital Lariboisière-Fernand-WidalCity: PARIS Recruiting
Paris, France, 75010
Contact: Florence VORSPAN, MD    33-1-40-05-42-75    florence.vorspan@lrb.aphp.fr   
Principal Investigator: Florence VORSPAN, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Florence VORSPAN, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Myriem TOUHAMI-CARRIER, Department of clinical research and development
ClinicalTrials.gov Identifier: NCT00894452     History of Changes
Other Study ID Numbers: P070603
Study First Received: March 31, 2009
Last Updated: December 2, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Methadone
CYP
OPRM1
MDR1
COMT
Midazolam challenge

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014