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

Completed

• Conditions: Opiate Abuse; Opioid-related Disorders; Opiate Dependence; Opiate Addiction
• Interventions: Genetic: COMT polymorphism

• Registration Number: NCT01570699
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Study Start: 2012-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2: patients included in METHADOSE study	COMT polymorphism	includes opiate-dependent patients substituted by methadone
1: opiate-non dependent patients	COMT polymorphism	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

Primary Outcome Measures

Name	Time	Method
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	Day 0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Espace Murger, Consultation toxicomanie, Fernand-Widal Hospital (AP-HP); 🇫🇷 Paris, Ile de France, France