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

This study is currently recruiting participants.
Verified December 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01570699
First received: February 2, 2012
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Opioid-related Disorders
Opiate Dependence
Opiate Addiction
Opiate Abuse
 Genetic: COMT polymorphism

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: COMT Val158Met Polymorphism in Opiate-using Subjects Without Lifetime Opiate Dependence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

Biospecimen Retention:   Samples With DNA

We will compare polymorphism COMT between COM-ON patients and METHADOSE patients. Samples may be blood sample or salivary sample.


Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
2: patients included in METHADOSE study
includes opiate-dependent patients substituted by methadone
 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
1: opiate-non dependent patients
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
 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

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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • Patient over 35 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570699

Contacts
Contact: Florence VORSPAN, MD, MSC +33 (0) 1 40 05 42 75 florence.vorspan@lrb.aphp.fr

Locations
France
Espace Murger, Consultation toxicomanie, Fernand-Widal Hospital (AP-HP) Recruiting
Paris, Ile de France, France, 75010
Principal Investigator: Florence VORSPAN, MD, MSC            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Florence VORSPAN, MD, MSC Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01570699     History of Changes
Other Study ID Numbers: CRC10 073, 2011-A00623-38
Study First Received: February 2, 2012
Last Updated: December 20, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cross-sectional observational study
COMT polymorphism
Opiate-users
Opiate dependence

Additional relevant MeSH terms:
Opioid-Related Disorders
Behavior, Addictive
Substance-Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on May 22, 2013