New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

Study Overview
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Brief Summary
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This is an experimental study in which the efficacy of three psychophysiological intervention modalities based on retrieval-extinction procedures is analyzed.

Detailed Description
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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.

Official Title
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New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

Conditions
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Alcoholism

Intervention / Treatment
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* Behavioral: Retrieval-Extinction Learning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alcohol-dependent patients who have been detoxified and abstinent take 10-14 days. Exclusion Criteria: Patients who do not sign the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate exposure<br>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<br>* 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.<br>|
| Active Comparator: Delayed exposure<br>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<br>* 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.<br>|
| Active Comparator: No exposure<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between pattern of brain connectivity after training-extinction and basal level |  | 2 days | 
| Number of relapses during 3 months after training-extinction |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between plasma levels of BDNF after training-extinction and basal level |  | 2 days | 
| Difference between attentional bias toward alcohol after training-extinction and basal level |  | 2 days | 
| Difference between behavioral inhibition after training-extinction and basal level |  | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Dependence, Brain Connectivity, Inhibition