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New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Retrieval-Extinction Learning
Sponsored by
Gabriel Rubio Valladolid, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcohol Dependence, Brain Connectivity, Inhibition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Immediate exposure

Delayed exposure

No exposure

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Difference between pattern of brain connectivity after training-extinction and basal level
Number of relapses during 3 months after training-extinction

Secondary Outcome Measures

Difference between plasma levels of BDNF after training-extinction and basal level
Difference between attentional bias toward alcohol after training-extinction and basal level
Difference between behavioral inhibition after training-extinction and basal level

Full Information

First Posted
October 11, 2016
Last Updated
March 7, 2023
Sponsor
Gabriel Rubio Valladolid, MD
Collaborators
Hospital Universitario 12 de Octubre, Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT03028662
Brief Title
New Therapeutic Strategies for the Treatment of Alcohol Use Disorders
Official Title
New Therapeutic Strategies for the Treatment of Alcohol Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gabriel Rubio Valladolid, MD
Collaborators
Hospital Universitario 12 de Octubre, Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcohol Dependence, Brain Connectivity, Inhibition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate exposure
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed exposure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No exposure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Retrieval-Extinction Learning
Intervention Description
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 Outcome Measure Information:
Title
Difference between pattern of brain connectivity after training-extinction and basal level
Time Frame
2 days
Title
Number of relapses during 3 months after training-extinction
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Difference between plasma levels of BDNF after training-extinction and basal level
Time Frame
2 days
Title
Difference between attentional bias toward alcohol after training-extinction and basal level
Time Frame
2 days
Title
Difference between behavioral inhibition after training-extinction and basal level
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Rubio Valladolid, Psychiatrist
Organizational Affiliation
Hospital Universitario 12 de Octubre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21389338
Citation
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.
Results Reference
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New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

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