An interventional study of Retrieval-Extinction Learning and rTMS in Alcoholism, sponsored by Hospital Universitario 12 de Octubre. Completed at 1 site in Spain. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-03-08.
Sponsored by Hospital Universitario 12 de Octubre · Not applicable, Interventional, and Treatment
This experimental research studies the efficacy of two different treatments for inhibitory control improvement in alcohol-dependent individuals, one consisting of Retrieval-Extinction Learning ( alcohol AAT Task) and the other consisting in rTMS of the right dorsolateral prefrontal cortex.
The main purpose of this study is to demonstrate the efficacy of two different treatments for inhibitory control improvement (measured by the modified Stop signal task): a behavioral treatment based on Retrieval-Extinction Learning, through the AAT (Alcohol Approach Avoiding Task) and a treatment based on the neuromodulation of prefrontal cortex through the rTMS (repetitive transcraneal magnetic stimulation) technique. To carry out this study, 105 alcoholic patients will be compared for clinical variables (abstinence/relapses), self-informed (UPPS) and behvavioral impulsivity (Stop signal task), along with biological measures for polymorphism determinations. Alcohol-dependent individuals will be divided into 4 groups of study (1:1 proportion for Retrieval-Extinction Learning with AAT and 2:1 (double for the effective technique comparing to placebo/control) for rTMS): Group 1 (N=30): exposure to an alcohol-related video followed by AAT; Group 2 (N=30): neutral-content video followed by AAT; Group 4 (30): active stimulation rTMS (10 Hz) ; Group 4 (N=15): placebo stimulation SAM.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 105 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Hospital Universitario 12 de Octubre is the lead sponsor of 33 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exposure to a 5 minutes video related to alcohol consumption (updating/retrieval), followed by 10 minutes of the alcohol- AAT(Approach Avoidance Task) (extinction), during 4 days of training (2 weeks).
Behavioral: Retrieval-Extinction Learning
Exposure to a 5 minutes video with neutral content (no retrieval) followed by 10 minutes of the alcohol- AAT (Approach Avoidance Task) , during 4 days of training.
Behavioral: Retrieval-Extinction Learning
Each session (5 sessions along 2 weeks), patients receive active stimulation with repetitive transcraneal magnetic stimulation (rTMS) of the right dorsolateral prefrontal cortex.
Other: rTMS
Pacients receiving a sham stimulation (SAM), with a similar procedure to the experimental condition
Other: SAM
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.
Previous to rTMS completion, MRI scans were performed in order to determinate the motor threshold trough 1Hz stimuli and locate the desired area with the neuronavigator. Motor threshold is defined as the stimulus with less intensity, able to generate a motor potential of at least 50 µV in 10 trials. Next, patients were called for 5 times per week, along 2 weeks, for receiving brain stimulation with Magstim Rapid coil. rTMS is performed at 10 Hz, during 4.9 seconds,for each set of stimuli (20), with a interval between sets of 30 seconds.
Previous to rTMS completion, MRI scans were performed in order to determinate the motor threshold trough 1Hz stimuli and locate the desired area with the neuronavigator. Motor threshold is defined as the stimulus with less intensity, able to generate a motor potential of at least 50 µV in 10 trials. Next, patients were called for 5 times per week, along 2 weeks, for receiving brain stimulation with SAM coil.
Relapses
Number of relapses
Time frame: 3 months
Heavy drinking
Number of days of heavy drinking
Time frame: 3 months
Abstinence
Days of accumulated abstinence
Time frame: 3 months
Behavioral Impulsivity
Stop signal task reaction times
Time frame: 2 days
Self-reported Impulsivity
scores for UPPS
Time frame: 2 days
Polymorphism distribution of CRH and ANK3 genes
Biological determinations-lymphocyte samples
Time frame: 2 days
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Hospital Universitario 12 de Octubre