A Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction : a Case Control Study (CRACK-ANT)
Primary Purpose
Dependence, Cocaine
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collect 10 ml of Saliva for DNA extraction
Sponsored by
About this trial
This is an interventional diagnostic trial for Dependence, Cocaine focused on measuring Diagnosis of dependence on cocaine according to DSM-IV-TR criteria
Eligibility 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
Sites / Locations
- Service de psychiatrie et addictologie - CHU de Fort-de-FranceRecruiting
Outcomes
Primary Outcome Measures
The specific measure that will be related to core objectives of the study is to constitute a sample collection from saliva.
Secondary Outcome Measures
Full Information
NCT ID
NCT01025219
First Posted
December 1, 2009
Last Updated
March 21, 2011
Sponsor
University Hospital Center of Martinique
1. Study Identification
Unique Protocol Identification Number
NCT01025219
Brief Title
A Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction : a Case Control Study
Acronym
CRACK-ANT
Official Title
A Case Control Study on Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Center of Martinique
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dependence, Cocaine
Keywords
Diagnosis of dependence on cocaine according to DSM-IV-TR criteria
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
Collect 10 ml of Saliva for DNA extraction
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérôme LACOSTE, MD
Phone
596 55 20 44
Ext
+596
Email
jerome.lacoste@chu-fortdefrance.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyne CRASPAG, Master
Phone
596 59 26 98
Ext
+596
Email
jocelyne.craspag@chu-fortdefrance.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme LACOSTE, MD
Organizational Affiliation
CHU de Fort-de-France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de psychiatrie et addictologie - CHU de Fort-de-France
City
Fort-de-France
State/Province
Martinique
ZIP/Postal Code
97261
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyne CRASPAG, Master
Phone
596 59 26 98
Ext
+596
Email
jocelyne.craspag@chu-fortdefrance.fr
First Name & Middle Initial & Last Name & Degree
Mickaëlle ROSE, Master
Phone
596 59 26 98
Ext
+596
Email
mickaelle.rose@chu-fortdefrance.fr
First Name & Middle Initial & Last Name & Degree
Jérôme LACOSTE, MD
12. IPD Sharing Statement
Learn more about this trial
A Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction : a Case Control Study
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