- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02108054
Cognitive and Behavioral Task Development for Alcohol Use Disorder Research
This clinical trial focuses on developing and testing behavioral and functional tasks to better understand cognitive, motivational, and decision-making processes in individuals with alcohol use disorders. The study aims to create reliable measurement tools for both traditional laboratory settings and advanced neuroimaging environments.
Study Objectives:
- Develop non-imaging cognitive/behavioral assessment tasks
- Adapt tasks for fMRI compatibility while maintaining measurement validity
- Explore alternative neuroimaging methods (EEG/fNIRS) for participants who cannot undergo MRI
Participant Groups: The study includes two parallel groups - healthy volunteers and individuals with alcohol dependence (DSM-IV-TR or DSM-5 criteria). Approximately 400 participants aged 18-65 will be enrolled.
Methodology Highlights:
- Pilot testing of novel or modified behavioral tasks
- Validation using 7T MRI technology for high-resolution functional brain imaging
- Comparative assessment of EEG and fNIRS as alternative neuroimaging modalities
The exclusion criteria are particularly important for MRI safety, prohibiting participants with metal implants, pregnancy, left-handedness, or claustrophobia. Alcohol-dependent inpatients must show no active withdrawal symptoms (CIWA ≤ 8).
This NIAAA-sponsored study represents an important step toward developing standardized neurobehavioral assessment tools for alcohol research. The ongoing nature of task development (through 2025) allows for iterative refinement of measurement approaches across multiple neuroimaging platforms.
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