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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01455207
Other study ID # 2011-A00495-36
Secondary ID 11-050
Status Recruiting
Phase N/A
First received October 18, 2011
Last updated April 8, 2014
Start date January 2012
Est. completion date January 2015

Study information

Verified date April 2014
Source University Hospital, Caen
Contact Julien Chavant, MA
Phone 2 31 06 54 95
Email memoire-recherche.caen@inserm.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

This research project aims to identify factors that contribute to the heterogeneity observed in neuroradiological and neuropsychological signs of chronic alcoholism. The investigators overarching hypothesis is that the heterogeneity of alcoholic consequences on brain structure and metabolism, and cognition is mainly related to individual differences in pattern of alcohol use, gene pool, nutritional status and history of withdrawal symptoms.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 70 Years
Eligibility Inclusion Criteria:

- Completed at least 8 years of education (primary school equivalent)

- Age-normal corrected hearing and visual acuity

Exclusion Criteria:

- documented loss of consciousness of over 30 minutes, documented compound skull fracture, or clear neurological sequelae of head trauma

- history of medical or neurological illness or trauma potentially affecting the CNS, e.g., stroke, multiple sclerosis, epilepsy, psychosurgery, insulin coma.

- active tuberculosis or history of or any malignancy requiring chemotherapy

- history of schizophrenia or bipolar disorder

- metal implantation (e.g., pacemakers) or other factors that preclude MRI scanning for subjects selected for the neuroimaging examination

- meet DSM-IV criteria for current (past 3 months) other Substance Abuse

- met DSM-IV criteria for other Substance Dependence

- Have used other substances more than 5 times in the past month

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Neuropsychological testing
assessment of memory, executive functions and ataxia
Biological:
blood draw
hepatic markers, red blood markers and vitamin markers
Genetic:
genetic testing
genes coding for thiamine enzymes (a-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)
Other:
Brain imaging examination
MRI, DTI and PET examinations

Locations

Country Name City State
France Caen University Hospital Caen

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Caen Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET) one year Yes
Secondary treatment outcomes (sobriety or relapse) one year Yes
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