New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

Not Applicable

Completed

• Conditions: Alcoholism
• Interventions: Behavioral: Retrieval-Extinction Learning

• Registration Number: NCT03028662
• Lead Sponsor: Gabriel Rubio Valladolid, MD

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Primary Completion: 2020-09
• Study Completion: 2020-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed exposure	Retrieval-Extinction Learning	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.
Immediate exposure	Retrieval-Extinction Learning	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.
No exposure	Retrieval-Extinction Learning	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.

Primary Outcome Measures

Name	Time	Method
Number of relapses during 3 months after training-extinction	3 months
Difference between pattern of brain connectivity after training-extinction and basal level	2 days

Secondary Outcome Measures

Name	Time	Method
Difference between attentional bias toward alcohol after training-extinction and basal level	2 days
Difference between plasma levels of BDNF after training-extinction and basal level	2 days
Difference between behavioral inhibition after training-extinction and basal level	2 days

Trial Locations

Locations (1)

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain