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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01570699
Acronym
COM-ON
Enrollment
87
Registered
2012-04-04
Start date
2012-12-31
Completion date
2016-06-30
Last updated
2016-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Abuse, Opiate Addiction, Opiate Dependence, Opioid-related Disorders

Keywords

Cross-sectional observational study, COMT polymorphism, Opiate-users, Opiate dependence

Brief summary

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

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.

Interventions

GENETICCOMT 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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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' groupDay 0

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026