New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

Alcoholism Clinical Trial

Official title:

New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028662
• Other study ID #: 2015-00463
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: March 2023
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholism

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Gabriel Rubio Valladolid, MD	Hospital Universitario 12 de Octubre, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between pattern of brain connectivity after training-extinction and basal level		2 days
Primary	Number of relapses during 3 months after training-extinction		3 months
Secondary	Difference between plasma levels of BDNF after training-extinction and basal level		2 days
Secondary	Difference between attentional bias toward alcohol after training-extinction and basal level		2 days
Secondary	Difference between behavioral inhibition after training-extinction and basal level		2 days