Alcoholism Clinical Trial
— ALCOBRAINOfficial title:
From Uncomplicated Alcoholism to Korsakoff's Syndrome: Clinical, Genetic, Neuropsychological and Brain Examinations
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.
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 |
Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Caen University Hospital | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen | Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France |
France,
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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