New Therapeutic Strategies for Inhibitory Control in Alcoholism

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03058276
• Other study ID #: 2015/099
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: December 2020

Study information

• Verified date: March 2023
• Source: Hospital Universitario 12 de Octubre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre	Ministerio de Sanidad, Servicios Sociales e Igualdad

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapses	Number of relapses	3 months
Primary	Heavy drinking	Number of days of heavy drinking	3 months
Primary	Abstinence	Days of accumulated abstinence	3 months
Secondary	Behavioral Impulsivity	Stop signal task reaction times	2 days
Secondary	Self-reported Impulsivity	scores for UPPS	2 days
Secondary	Polymorphism distribution of CRH and ANK3 genes	Biological determinations-lymphocyte samples	2 days