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Completed

NCT Number: NCT01570699

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

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Paris, Île-de-France Region, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COMT polymorphism

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Score on the M.I.N.I. (Mini-International Neuropsychiatric Interview) on the day of the inclusion

    Time frame: Day 0

  2. Score on the BIS (Barratt Impulsivity Scale) on the day of the inclusion

    Time frame: Day 0

  3. Score on the TCI (Cloninger's Temperament and Character Inventory) on the day of the inclusion

    Time frame: Day 0

  4. Score on the WURS (Wender Utah Rating Scale) on the day of the inclusion

    Time frame: Day 0

  5. Score on the ASRS(Self-Report Scale) on the day of the inclusion

    Time frame: Day 0

  6. Score on the MOPS (Measure Of Parental Style) on the day of the inclusion

    Time frame: Day 0

  7. Score on the Questionnaire of family breakdowns on the day of the inclusion

    Time frame: Day 0

  8. Score on the CD-RISC (Connor-Davidson Resilience scale) on the day of the inclusion

    Time frame: Day 0

  9. Score on the CTQ (Childhood trauma questionnaire) on the day of the inclusion

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: COM-ON

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2012
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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