Variation of COMT Val158Met Polymorphism Between COM-ON Patients and METHADOSE Patients

NCT ID: NCT01570699

Last Updated: 2016-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-06-30

Brief Summary

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The main objective is to compare the genotypes of the COMT Val158Met polymorphism between opiate-users and opiate-dependent subjects. The secondary objective is to constitute a sample of opiate-users without any lifetime opiate dependence.

Detailed Description

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The COMT enzyme enables the degradation of brain monoamines such as Dopamine and is encoded by a single gene for which several polymorphisms are known, including the Val158Met polymorphism which has been widely studied in various psychiatric disorders, including addictions, as well as in impulsivity. In most studies it is the Val allele which is found to be associated with addictive behaviors. The study METHADOSE, which began in 2009, includes opiate-dependent patients substituted by methadone. The preliminary analysis of this study shows a genotype distribution different from that of general population samples, with a greater prevalence of Val / Val and Val / Met genotypes. Will be included in the COM ON study subjects who have consumed illicit opiates (heroin, methadone, buprenorphine or morphine) more than 10 times in their life, without ever having the DSM-IV criteria for opiate dependence or abuse. The study will compare, by means of saliva samples, Val / Val and Val / Met genotypes between the subjects recruited in COM ON and those recruited in METHADOSE. Will also be included auto-questionnaires to identify psychological factors that may constitute risk or protective factors vis-à-vis the development of dependence.

Conditions

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Opioid-related Disorders Opiate Dependence Opiate Addiction Opiate Abuse

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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2: patients included in METHADOSE study

includes opiate-dependent patients substituted by methadone

COMT polymorphism

Intervention Type GENETIC

The COMT enzyme enables the degradation of brain monoamines such as Dopamine and is encoded by a single gene for which several polymorphisms are known, including the Val158Met polymorphism which has been widely studied in various psychiatric disorders including addictions, as well as in impulsivity

1: opiate-non dependent patients

Will be included in the COM ON study subjects who have consumed illicit opiates (heroin, methadone, buprenorphine or morphine) more than 10 times in their life, without ever having the DSM-IV criteria for opiate dependence or abuse

COMT polymorphism

Intervention Type GENETIC

The COMT enzyme enables the degradation of brain monoamines such as Dopamine and is encoded by a single gene for which several polymorphisms are known, including the Val158Met polymorphism which has been widely studied in various psychiatric disorders including addictions, as well as in impulsivity

Interventions

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COMT polymorphism

The COMT enzyme enables the degradation of brain monoamines such as Dopamine and is encoded by a single gene for which several polymorphisms are known, including the Val158Met polymorphism which has been widely studied in various psychiatric disorders including addictions, as well as in impulsivity

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Patient over 18 years old
* Caucasian patients
* Clinical diagnosis of lifetime opiate-using disorder (consumption over 10 times of illicit opiates (heroin, buprenorphine, methadone or morphine))
* Not lifetime history of opioid dependence (DSMIV)
* Patients with health insurance coverage
* Patient was treated with opioids analgesics to alleviate 2 or 3 in their lives

Exclusion Criteria

* Non-Caucasian patients
* Patients who cannot give their consent and/or who refuse the collection of genetic data
* Patients with no health insurance coverage
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence VORSPAN, MD, MSC

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Espace Murger, Consultation toxicomanie, Fernand-Widal Hospital (AP-HP)

Paris, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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2011-A00623-38

Identifier Type: OTHER

Identifier Source: secondary_id

CRC10 073

Identifier Type: -

Identifier Source: org_study_id

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