New Therapeutic Strategies for Inhibitory Control in Alcoholism

Madrid Health Service

Status: Completed

Conditions: Alcoholism

Treatments: Other: SAM; Other: rTMS; Behavioral: Retrieval-Extinction Learning

Study type: Interventional

Funder types: Other

Identifiers

NCT03058276

2015/099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 4 patient groups

Exposure

Experimental group

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).

Treatment:

Behavioral: Retrieval-Extinction Learning

No exposure

Active Comparator group

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.

Treatment:

Behavioral: Retrieval-Extinction Learning

Active rTMS

Experimental group

Description:

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

Treatment:

Other: rTMS

SAM

Sham Comparator group

Description:

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

Treatment:

Other: SAM