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OpenTrials
Completed

NCT Number: NCT03028662

New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Retrieval-Extinction Learning

Behavioral

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.

Primary outcomes

  1. Difference between pattern of brain connectivity after training-extinction and basal level

    Time frame: 2 days

  2. Number of relapses during 3 months after training-extinction

    Time frame: 3 months

Secondary outcomes

  1. Difference between plasma levels of BDNF after training-extinction and basal level

    Time frame: 2 days

  2. Difference between attentional bias toward alcohol after training-extinction and basal level

    Time frame: 2 days

  3. Difference between behavioral inhibition after training-extinction and basal level

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Gabriel Rubio Valladolid, MD

Other

Collaborators

  • Hospital Universitario 12 de Octubre
  • Instituto de Salud Carlos III

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2017
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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