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A Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction : a Case Control Study (CRACK-ANT)

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ClinicalTrials.gov Identifier: NCT01025219
Recruitment Status : Unknown
Verified March 2011 by University Hospital Center of Martinique.
Recruitment status was:  Recruiting
First Posted : December 3, 2009
Last Update Posted : March 22, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to assess the phenotypic candidates symptoms, in patients with crack/cocaine addiction, in terms of clinical comorbidities, dimensions of personality, and neuropsychological evaluations apt to be associated with genetic and genotypic characterisations, notably on the polymorphisms of the genes coding or regulating dopaminergic, norepinephrine and serotoninergic systems.

Condition or disease Intervention/treatment
Dependence, Cocaine Genetic: Collect 10 ml of Saliva for DNA extraction

Detailed Description:
Genetic studies show an association between drug addiction and the dopaminergic system and its modulators. Nonetheless, results are contradictory, partially due to the heterogeneity of the phenotype addiction. Placed on the trafficking route of cocaine, and homogeneously populated, Martinique is of particular interest for the study of the vulnerability of the crack/cocaine addiction. In a precedent study, supported by a grant MILDT / INSERM 2000, on 155 men dependent to crack/cocaine and characterised with three clinical dimensions -sensation seeking, impulsivity and childhood ADHD- we found an association between each dimension and polymorphisms of DRD2 and DRD4 genes.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Case Control Study on Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction
Study Start Date : December 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Genetic: Collect 10 ml of Saliva for DNA extraction
    After signed written informed consent, all patients and controls have clinical and neuropsychological evaluations (DIGS, WURS, BROWN, BIS, SSS and IGT) for phenotypic diagnosis and collection of saliva for DNA extraction and genotyping diagnosis.

Outcome Measures

Primary Outcome Measures :
  1. The specific measure that will be related to core objectives of the study is to constitute a sample collection from saliva. [ Time Frame: The saliva will be collect at the end of the first visit ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of cocaine abuse/dependence according to DSM-IV-TR criteria
  • Come from French West Indies (3 grandparents are African-Caribbean)
  • Sign a written informed consent

Exclusion Criteria:

  • Minor
  • Men with no cocaine abuse/dependence according to DSM-IV-TR criteria

For the control:

Inclusion Criteria:

  • Platelets donor
  • No substance abuse/dependence according to DSM-IV-TR criteria
  • Come from French West Indies (3 grandparents are African-Caribbean)
  • Sign a written informed consent

Exclusion Criteria:

  • Minor
  • Men refusing a genetic study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025219


Contacts
Contact: Jérôme LACOSTE, MD 596 55 20 44 ext +596 jerome.lacoste@chu-fortdefrance.fr
Contact: Jocelyne CRASPAG, Master 596 59 26 98 ext +596 jocelyne.craspag@chu-fortdefrance.fr

Locations
France
Service de psychiatrie et addictologie - CHU de Fort-de-France Recruiting
Fort-de-France, Martinique, France, 97261
Contact: Jocelyne CRASPAG, Master    596 59 26 98 ext +596    jocelyne.craspag@chu-fortdefrance.fr   
Contact: Mickaëlle ROSE, Master    596 59 26 98 ext +596    mickaelle.rose@chu-fortdefrance.fr   
Principal Investigator: Jérôme LACOSTE, MD         
Sponsors and Collaborators
University Hospital Center of Martinique
Investigators
Principal Investigator: Jérôme LACOSTE, MD CHU de Fort-de-France
More Information

Responsible Party: RIAM Daniel, CHU de Fort-de-France
ClinicalTrials.gov Identifier: NCT01025219     History of Changes
Other Study ID Numbers: 09/B/01
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: March 22, 2011
Last Verified: March 2011

Keywords provided by University Hospital Center of Martinique:
Diagnosis of dependence on cocaine according to DSM-IV-TR criteria

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents