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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT01570699
• Date of registration: 02/02/2012
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Variation of COMT Val158Met Polymorphism Between COM-ON Patients and METHADOSE Patients COM-ON
• Scientific title: COMT Val158Met Polymorphism in Opiate-using Subjects Without Lifetime Opiate Dependence
• Date of first enrolment: December 2012
• Target sample size: 87
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01570699
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Cross-Sectional
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Florence VORSPAN, MD, MSC
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 35 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Opiate Addiction

Opiate Dependence

Opioid-related Disorders

Opiate Abuse

Intervention(s)

Genetic: COMT polymorphism

Primary Outcome(s)

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 Outcome(s)

Score on the CD-RISC (Connor-Davidson Resilience scale) on the day of the inclusion [Time Frame: Day 0]

Score on the Questionnaire of family breakdowns on the day of the inclusion [Time Frame: Day 0]

Score on the TCI (Cloninger's Temperament and Character Inventory) on the day of the inclusion [Time Frame: Day 0]

Score on the CTQ (Childhood trauma questionnaire) on the day of the inclusion [Time Frame: Day 0]

Score on the WURS (Wender Utah Rating Scale) on the day of the inclusion [Time Frame: Day 0]

Score on the BIS (Barratt Impulsivity Scale) on the day of the inclusion [Time Frame: Day 0]

Score on the M.I.N.I. (Mini-International Neuropsychiatric Interview) on the day of the inclusion [Time Frame: Day 0]

Score on the MOPS (Measure Of Parental Style) on the day of the inclusion [Time Frame: Day 0]

Score on the ASRS(Self-Report Scale) on the day of the inclusion [Time Frame: Day 0]

Secondary ID(s)

2011-A00623-38

CRC10 073

Source(s) of Monetary Support

Please refer to primary and secondary sponsors