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

September 28, 2016 updated by: Assistance Publique - Hôpitaux de Paris

COMT Val158Met Polymorphism in Opiate-using Subjects Without Lifetime Opiate Dependence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75010
        • Espace Murger, Consultation toxicomanie, Fernand-Widal Hospital (AP-HP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2: patients included in METHADOSE study
includes opiate-dependent patients substituted by methadone
Genetic: 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
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
Genetic: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with each COMT genotype (Val/Val, Val/Met and Met/Met) in the opiate-users' group and in the opiate-dependent subjects' group
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Score on the M.I.N.I. (Mini-International Neuropsychiatric Interview) on the day of the inclusion
Time Frame: Day 0
Day 0
Score on the BIS (Barratt Impulsivity Scale) on the day of the inclusion
Time Frame: Day 0
Day 0
Score on the TCI (Cloninger's Temperament and Character Inventory) on the day of the inclusion
Time Frame: Day 0
Day 0
Score on the WURS (Wender Utah Rating Scale) on the day of the inclusion
Time Frame: Day 0
Day 0
Score on the ASRS(Self-Report Scale) on the day of the inclusion
Time Frame: Day 0
Day 0
Score on the MOPS (Measure Of Parental Style) on the day of the inclusion
Time Frame: Day 0
Day 0
Score on the Questionnaire of family breakdowns on the day of the inclusion
Time Frame: Day 0
Day 0
Score on the CD-RISC (Connor-Davidson Resilience scale) on the day of the inclusion
Time Frame: Day 0
Day 0
Score on the CTQ (Childhood trauma questionnaire) on the day of the inclusion
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Florence VORSPAN, MD, MSC, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 2, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC10 073
  • 2011-A00623-38 (Other Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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