Clinical Trials Directory

Trials / Completed

CompletedNCT03028662

New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
115 (actual)
Sponsor
Gabriel Rubio Valladolid, MD · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALRetrieval-Extinction LearningThe 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.

Timeline

Start date
2016-01-01
Primary completion
2020-09-01
Completion
2020-12-01
First posted
2017-01-23
Last updated
2023-03-08

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03028662. Inclusion in this directory is not an endorsement.