New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

February 20, 2019 updated by: Gabriel Rubio Valladolid, MD
This is an experimental study in which the efficacy of three psychophysiological intervention modalities based on retrieval-extinction procedures is analyzed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: 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.
ACTIVE_COMPARATOR: 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.
Behavioral: 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.
ACTIVE_COMPARATOR: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between pattern of brain connectivity after training-extinction and basal level
Time Frame: 2 days
2 days
Number of relapses during 3 months after training-extinction
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference between plasma levels of BDNF after training-extinction and basal level
Time Frame: 2 days
2 days
Difference between attentional bias toward alcohol after training-extinction and basal level
Time Frame: 2 days
2 days
Difference between behavioral inhibition after training-extinction and basal level
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gabriel Rubio Valladolid, MD

Collaborators

Instituto de Salud Carlos III
Hospital Universitario 12 de Octubre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

January 19, 2017

First Posted (ESTIMATE)

January 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-00463

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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