Clinical trial NCT01570699: Variation of COMT Val158Met Polymorphism Between COM-ON Patients and METHADOSE Patients
Official title: COMT Val158Met Polymorphism in Opiate-using Subjects Without Lifetime Opiate Dependence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-related Disorders
Opiate Dependence
Opiate Addiction
Opiate Abuse
Keywords: Cross-sectional observational study
COMT polymorphism
Opiate-users
Opiate dependence
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 87
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Day 0
Secondary outcomes:
measure: Score on the M.I.N.I. (Mini-International Neuropsychiatric Interview) on the day of the inclusion
timeFrame: Day 0
measure: Score on the BIS (Barratt Impulsivity Scale) on the day of the inclusion
timeFrame: Day 0
measure: Score on the TCI (Cloninger's Temperament and Character Inventory) on the day of the inclusion
timeFrame: Day 0
measure: Score on the WURS (Wender Utah Rating Scale) on the day of the inclusion
timeFrame: Day 0
measure: Score on the ASRS(Self-Report Scale) on the day of the inclusion
timeFrame: Day 0
measure: Score on the MOPS (Measure Of Parental Style) on the day of the inclusion
timeFrame: Day 0
measure: Score on the Questionnaire of family breakdowns on the day of the inclusion
timeFrame: Day 0
measure: Score on the CD-RISC (Connor-Davidson Resilience scale) on the day of the inclusion
timeFrame: Day 0
measure: Score on the CTQ (Childhood trauma questionnaire) on the day of the inclusion
timeFrame: Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Espace Murger, Consultation toxicomanie, Fernand-Widal Hospital (AP-HP)
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Florence VORSPAN, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References: