A Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction : a Case Control Study

Dependence, Cocaine Clinical Trial

— CRACK-ANT  

Official title:

A Case Control Study on Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01025219
• Other study ID #: 09/B/01
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2009
• Last updated: March 21, 2011
• Start date: December 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2011
• Source: Centre Hospitalier Universitaire de Fort-de-France
• Contact: Jérôme LACOSTE, MD
• Phone: 596 55 20 44
• Email: jerome.lacoste[@]chu-fortdefrance.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dependence, Cocaine

Intervention

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.

Locations

Country	Name	City	State
France	Service de psychiatrie et addictologie - CHU de Fort-de-France	Fort-de-France	Martinique

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Fort-de-France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The specific measure that will be related to core objectives of the study is to constitute a sample collection from saliva.		The saliva will be collect at the end of the first visit	No