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New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

New Therapeutic Strategies for the Treatment of Alcohol Use Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03028662
Enrollment
115
Registered
2017-01-23
Start date
2016-01-31
Completion date
2020-12-31
Last updated
2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism

Keywords

Alcohol Dependence, Brain Connectivity, Inhibition

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.

Interventions

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.

Sponsors

Hospital Universitario 12 de Octubre
CollaboratorOTHER
Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Gabriel Rubio Valladolid, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Difference between pattern of brain connectivity after training-extinction and basal level2 days
Number of relapses during 3 months after training-extinction3 months

Secondary

MeasureTime frame
Difference between plasma levels of BDNF after training-extinction and basal level2 days
Difference between attentional bias toward alcohol after training-extinction and basal level2 days
Difference between behavioral inhibition after training-extinction and basal level2 days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026