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NCT Number: NCT03058276

New Therapeutic Strategies for Inhibitory Control in Alcoholism

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.

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Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrieval-Extinction Learning

Behavioral

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.

rTMS

Other

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.

SAM

Other

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.

Primary outcomes

  1. Relapses

    Time frame: 3 months

    Number of relapses

  2. Heavy drinking

    Time frame: 3 months

    Number of days of heavy drinking

  3. Abstinence

    Time frame: 3 months

    Days of accumulated abstinence

Secondary outcomes

  1. Behavioral Impulsivity

    Time frame: 2 days

    Stop signal task reaction times

  2. Self-reported Impulsivity

    Time frame: 2 days

    scores for UPPS

  3. Polymorphism distribution of CRH and ANK3 genes

    Time frame: 2 days

    Biological determinations-lymphocyte samples

Sponsors and collaborators

Lead sponsor

Hospital Universitario 12 de Octubre

Other

Collaborators

  • Ministerio de Sanidad, Servicios Sociales e Igualdad

Registry information

Official study title

New Therapeutic Strategies for Inhibitory Control Improvement of Alcohol-dependent Patients

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2017
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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