An interventional study of Retrieval-Extinction Learning in Alcoholism, sponsored by Gabriel Rubio Valladolid, MD. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-08.
Sponsored by Gabriel Rubio Valladolid, MD · Not applicable, Interventional, and Treatment
This is an experimental study in which the efficacy of three psychophysiological intervention modalities based on retrieval-extinction procedures is analyzed.
Behavioral inhibition processes are a particularly relevant in relapses of patients with alcohol dependence. One of the current behavioral techniques to improve inhibitory abilities of these patients is the alcohol Approach Avoidance Task (AAT). However, this technique could be more efficient if patients, before training in this task, were exposed to a variety of alcohol-conditioned stimuli (retrieval) and take advantage of the window period of reconsolidation of these memories to carry out this task (extinction training). This project will attempt to show the pattern of brain connectivity underlying retrieval-extinction learning, its relationship with markers such as Brain-Derived Neurotrophic Factor (BDNF) and their usefulness to reduce relapses of individual with alcohol dependence. To carry out this study 115 patients with alcohol dependence who will be randomized into three groups: Group 1 (N = 35) where the extinction training is performed within the window period (10 minutes); Group 2 (N = 35) extinction will take place outside the time window (6 hours); Group 3 (N = 35), these subjects will be exposed to "non-retrieval" but with extinction-training within the window period. Changes in connectivity will be assessed with Electroencephalogram (EEG) at baseline and after 4 training sessions, using the HERMES platform. BDNF levels will be determined as peripheral markers of neurogenesis. These changes will be are correlated with relapses in the 12 weeks of follow-up.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 115 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →This is the only study on the registry with Gabriel Rubio Valladolid, MD as lead sponsor.
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Exclusion Criteria:
Exposure to video on alcohol (update phase) followed (10 minutes) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.
Behavioral: Retrieval-Extinction Learning
Exposure to a video of alcohol consumption (update phase) followed (6 hours) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.
Behavioral: Retrieval-Extinction Learning
Exposure to a video of neutral situations (update phase) followed (10 minutes) by the task of approach-avoidance of alcohol (extinction phase) (Retrieval-Extinction Learning), during 4 days of training.
Behavioral: Retrieval-Extinction Learning
The intervention consists of the accomplishment of the task of approach-avoidance of alcohol during 4 days of training. Subjects are instructed to respond with an approach movement (pulling a lever) to neutral images and to respond with avoidance movement (pushing the lever) to images of alcohol.
Difference between pattern of brain connectivity after training-extinction and basal level
Time frame: 2 days
Number of relapses during 3 months after training-extinction
Time frame: 3 months
Difference between plasma levels of BDNF after training-extinction and basal level
Time frame: 2 days
Difference between attentional bias toward alcohol after training-extinction and basal level
Time frame: 2 days
Difference between behavioral inhibition after training-extinction and basal level
Time frame: 2 days
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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