Alcoholism
Conditions
Keywords
rTMS, AAT, Alcohol-Dependence, Relapses
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALRetrieval-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.
OTHERrTMS
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.
OTHERSAM
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.
Sponsors
Ministerio de Sanidad, Servicios Sociales e Igualdad
Hospital Universitario 12 de Octubre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded experiment regarding rTMS treatment is applied to both subjects and investigators. The only non-masked role is for the technician applying either Magstim Rapid or SAM coils to each group of subjects.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged between 18 and 50 years old. * A minimum of 28 days of abstinence * Consent to participate in the study.
Exclusion criteria
* Subjects with other substance dependence ( with the exception of tobacco) * Subjects with a history of brain injury or neurological diseases * Denial for study participation * Non-spanish speakers * rTMS selected participants with be assed in order to discard epilepsy, presence for metallic elements and CNS valves
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapses | 3 months | Number of relapses |
| Heavy drinking | 3 months | Number of days of heavy drinking |
| Abstinence | 3 months | Days of accumulated abstinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Impulsivity | 2 days | Stop signal task reaction times |
| Self-reported Impulsivity | 2 days | scores for UPPS |
| Polymorphism distribution of CRH and ANK3 genes | 2 days | Biological determinations-lymphocyte samples |
Countries
Spain
Outcome results
None listed