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

Opioid-related Disorders Clinical Trial

— COM-ON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570699
• Other study ID #: CRC10 073
• Secondary ID: 2011-A00623-38
• Status: Completed
• Phase: N/A
• First received: February 2, 2012
• Last updated: September 28, 2016
• Start date: December 2012
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
France	Espace Murger, Consultation toxicomanie, Fernand-Widal Hospital (AP-HP)	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Score on the M.I.N.I. (Mini-International Neuropsychiatric Interview) on the day of the inclusion		Day 0	No
Secondary	Score on the BIS (Barratt Impulsivity Scale) on the day of the inclusion		Day 0	No
Secondary	Score on the TCI (Cloninger's Temperament and Character Inventory) on the day of the inclusion		Day 0	No
Secondary	Score on the WURS (Wender Utah Rating Scale) on the day of the inclusion		Day 0	No
Secondary	Score on the ASRS(Self-Report Scale) on the day of the inclusion		Day 0	No
Secondary	Score on the MOPS (Measure Of Parental Style) on the day of the inclusion		Day 0	No
Secondary	Score on the Questionnaire of family breakdowns on the day of the inclusion		Day 0	No
Secondary	Score on the CD-RISC (Connor-Davidson Resilience scale) on the day of the inclusion		Day 0	No
Secondary	Score on the CTQ (Childhood trauma questionnaire) on the day of the inclusion		Day 0	No