Clinical trial NCT03028662: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Keywords: Alcohol Dependence
Brain Connectivity
Inhibition
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
name: Instituto de Salud Carlos III
First posted: 2017-01-23
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Difference between pattern of brain connectivity after training-extinction and basal level
timeFrame: 2 days
measure: Number of relapses during 3 months after training-extinction
timeFrame: 3 months
Secondary outcomes:
measure: Difference between plasma levels of BDNF after training-extinction and basal level
timeFrame: 2 days
measure: Difference between attentional bias toward alcohol after training-extinction and basal level
timeFrame: 2 days
measure: Difference between behavioral inhibition after training-extinction and basal level
timeFrame: 2 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Gabriel Rubio Valladolid, Psychiatrist
role: PRINCIPAL_INVESTIGATOR
References:
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.