New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

NCT ID: NCT03028662

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2020-12-31

Brief 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

Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate exposure

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.

Group Type: EXPERIMENTAL

Retrieval-Extinction Learning

Intervention Type: 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.

Delayed exposure

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.

Group Type: ACTIVE_COMPARATOR

Retrieval-Extinction Learning

Intervention Type: 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.

No exposure

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.

Group Type: ACTIVE_COMPARATOR

Retrieval-Extinction Learning

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role: collaborator

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Gabriel Rubio Valladolid, MD

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Rubio Valladolid, MD

Psychiatrist, MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gabriel Rubio Valladolid, Psychiatrist

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre

Locations

Hospital Universitario 12 de Octubre

Madrid, , Spain

Countries

Spain

References

Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.

Reference Type: BACKGROUND

PMID: 21389338 (View on PubMed)

Other Identifiers

2015-00463

Identifier Type: -

Identifier Source: org_study_id