Variance of Oral Methadone Dosage: Description of Implicated Factors (METHADOSE)
Recruitment status was Recruiting
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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. |
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) |
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 |
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
Contacts and Locations| Contact: Florence VORSPAN, MD | 33-1-40 05 42 75 | florence.vorspan@lrb.aphp.fr |
| 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 | |
| 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 May 22, 2013