New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

Gabriel Rubio Valladolid, MD

Status: Completed

Conditions: Alcoholism

Treatments: Behavioral: Retrieval-Extinction Learning

Study type: Interventional

Funder types: Other

Identifiers

NCT03028662

2015-00463

Details and patient eligibility

About

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

Full description

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.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 3 patient groups

Immediate exposure

Experimental group

Description:

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.

Treatment:

Behavioral: Retrieval-Extinction Learning

Delayed exposure

Active Comparator group

Description:

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.

Treatment:

Behavioral: Retrieval-Extinction Learning

No exposure

Active Comparator group

Description:

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.

Treatment:

Behavioral: Retrieval-Extinction Learning