Clinical trial NCT03058276: New Therapeutic Strategies for Inhibitory Control in Alcoholism
Official title: New Therapeutic Strategies for Inhibitory Control Improvement of Alcohol-dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Keywords: rTMS
AAT
Alcohol-Dependence
Relapses
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Ministerio de Sanidad, Servicios Sociales e Igualdad
First posted: 2017-02-20
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Relapses
timeFrame: 3 months
measure: Heavy drinking
timeFrame: 3 months
measure: Abstinence
timeFrame: 3 months
Secondary outcomes:
measure: Behavioral Impulsivity
timeFrame: 2 days
measure: Self-reported Impulsivity
timeFrame: 2 days
measure: Polymorphism distribution of CRH and ANK3 genes
timeFrame: 2 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Gabriel Rubio Valladolid, Psychiatrist
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.