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Trial record 11 of 123 for:    Recruiting, Not yet recruiting, Available Studies | "Alcoholism"

New Therapeutic Strategies for Inhibitory Control in Alcoholism

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ClinicalTrials.gov Identifier: NCT03058276
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Ministerio de Sanidad, Servicios Sociales e Igualdad
Information provided by (Responsible Party):
Gabriel Rubio Valladolid, MD, Hospital Universitario 12 de Octubre

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.

Condition or disease Intervention/treatment Phase
Alcoholism Behavioral: Retrieval-Extinction Learning Other: rTMS Other: SAM Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Primary Purpose: Treatment
Official Title: New Therapeutic Strategies for Inhibitory Control Improvement of Alcohol-dependent Patients
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exposure
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
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.

Active Comparator: No exposure
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
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.

Experimental: Active rTMS
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
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.

Sham Comparator: SAM
Pacients receiving a sham stimulation (SAM), with a similar procedure to the experimental condition
Other: SAM
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058276


Contacts
Contact: Gabriel Rubio Valladolid, Psychiatrist +34913908019 gabriel.rubio@salud.madrid.org

Locations
Spain
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Gabriel Rubio Valladolid, Psychiatrist    +34913908019    gabriel.rubio@salud.madrid.org   
Contact: Rosa Jurado Barba, Psychologist    +34 637828151    mrjurado@ucjc.edu   
Sponsors and Collaborators
Hospital Universitario 12 de Octubre
Ministerio de Sanidad, Servicios Sociales e Igualdad
Investigators
Principal Investigator: Gabriel Rubio Valladolid, Psychiatrist Hospital Universitario 12 de Octubre

Publications:
Responsible Party: Gabriel Rubio Valladolid, MD, Psychiatrist, MD, PhD, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT03058276     History of Changes
Other Study ID Numbers: 2015/099
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gabriel Rubio Valladolid, MD, Hospital Universitario 12 de Octubre:
rTMS
AAT
Alcohol-Dependence
Relapses

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs