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New Therapeutic Strategies for Inhibitory Control in Alcoholism

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Retrieval-Extinction Learning
rTMS
SAM
Sponsored by
Hospital Universitario 12 de Octubre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring rTMS, AAT, Alcohol-Dependence, Relapses

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Sham Comparator

Arm Label

Exposure

No exposure

Active rTMS

SAM

Arm Description

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).

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.

Each session (5 sessions along 2 weeks), patients receive active stimulation with repetitive transcraneal magnetic stimulation (rTMS) of the right dorsolateral prefrontal cortex.

Pacients receiving a sham stimulation (SAM), with a similar procedure to the experimental condition

Outcomes

Primary Outcome Measures

Relapses
Number of relapses
Heavy drinking
Number of days of heavy drinking
Abstinence
Days of accumulated abstinence

Secondary Outcome Measures

Behavioral Impulsivity
Stop signal task reaction times
Self-reported Impulsivity
scores for UPPS
Polymorphism distribution of CRH and ANK3 genes
Biological determinations-lymphocyte samples

Full Information

First Posted
February 15, 2017
Last Updated
March 7, 2023
Sponsor
Hospital Universitario 12 de Octubre
Collaborators
Ministerio de Sanidad, Servicios Sociales e Igualdad
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1. Study Identification

Unique Protocol Identification Number
NCT03058276
Brief Title
New Therapeutic Strategies for Inhibitory Control in Alcoholism
Official Title
New Therapeutic Strategies for Inhibitory Control Improvement of Alcohol-dependent Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario 12 de Octubre
Collaborators
Ministerio de Sanidad, Servicios Sociales e Igualdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
rTMS, AAT, Alcohol-Dependence, Relapses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure
Arm Type
Experimental
Arm Description
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).
Arm Title
No exposure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Active rTMS
Arm Type
Experimental
Arm Description
Each session (5 sessions along 2 weeks), patients receive active stimulation with repetitive transcraneal magnetic stimulation (rTMS) of the right dorsolateral prefrontal cortex.
Arm Title
SAM
Arm Type
Sham Comparator
Arm Description
Pacients receiving a sham stimulation (SAM), with a similar procedure to the experimental condition
Intervention Type
Behavioral
Intervention Name(s)
Retrieval-Extinction Learning
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
rTMS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
SAM
Intervention Description
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 Measure Information:
Title
Relapses
Description
Number of relapses
Time Frame
3 months
Title
Heavy drinking
Description
Number of days of heavy drinking
Time Frame
3 months
Title
Abstinence
Description
Days of accumulated abstinence
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Behavioral Impulsivity
Description
Stop signal task reaction times
Time Frame
2 days
Title
Self-reported Impulsivity
Description
scores for UPPS
Time Frame
2 days
Title
Polymorphism distribution of CRH and ANK3 genes
Description
Biological determinations-lymphocyte samples
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Rubio Valladolid, Psychiatrist
Organizational Affiliation
Hospital Universitario 12 de Octubre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21389338
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.
Results Reference
background
PubMed Identifier
20078462
Citation
Mishra BR, Nizamie SH, Das B, Praharaj SK. Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. Addiction. 2010 Jan;105(1):49-55. doi: 10.1111/j.1360-0443.2009.02777.x.
Results Reference
background

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New Therapeutic Strategies for Inhibitory Control in Alcoholism

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