Severe Alcohol-use Disorder: a tDCS and Response Inhibition Training Intervention

Brugmann University Hospital136 enrolled

Overview

Most severe forms of alcohol-use disorder are thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators propose that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined, which might ultimately result is a reduction of alcohol relapse rate.

Treating Alcohol dependence remains notoriously difficult despite use of several medications, psychotherapeutic and psychosocial interventions. Alcohol dependence is thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators proposes that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined. tDCS has been found to improve working memory, which is necessary to evaluate long-term consequences of actions. ICT is able to modify the automatic approach tendencies towards appetitive cues. The investigators will recruit 160 alcohol-dependent patients and divide them randomly between four treatment conditions : real transcranial Direct Current Stimulation (tDCS) with active or control Inhibitory Control Technique (ICT ); or sham (placebo) tDCS with active or control ICT. Patients will be evaluated with primary outcome measures (alcohol consumption patterns) and secondary outcome measures (working memory and changes in alcohol-related stimuli affective values).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

136

Conditions

Alcohol Use Disorder

Interventions

Combined TDCS active and ICT activeBEHAVIORAL

Five 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days

Combined TDCS sham and ICT activeBEHAVIORAL

Five 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days

Combined TDCS active and ICT inactiveBEHAVIORAL

Five 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with severe alcohol-use disorder (DSM-5 criteria), hospitalized for detoxification. * Severity of alcohol use disorder must be at least moderate (at least 4 DSM-5 criteria) * Aged between 18 and 65 years * Comorbidity with anxiety disorders and depressive disorders is allowed * Patients must be illegal drug free for 3 weeks at beginning of trial * Pharmacotherapy: patients should be benzodiazepines free at the moment of inclusion. They are allowed to continue other psychotropic medication (antidepressants, antipsychotics, mood stabilizers), providing they are following a stable regimen that will not be changed during the protocol time. * Patients must be reachable for follow-up Exclusion Criteria: * Previous neurological conditions (epilepsy, traumatic brain injury, stroke) * Present delirium, confusion or severe cognitive disorder * Schizophrenia, chronic psychotic disorders, bipolar type 1 disorder. * Any severe, life-threatening disorders * High suicidal risk * Specific contraindications for tDCS: metallic plates in the head * Alcohol medication treatment initiated during the rehab: acamprosate, disulfiram, baclofen, nalmefen.

Locations (1)

CHU-Brugmann

Brussels, Belgium

Outcomes

Primary Outcomes

Reduction of alcohol use in post-treatment at week 2

Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)

Time frame: é weeks post-rehab

Reduction of alcohol use in post-treatment at week 4

Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)

Time frame: 4 weeks post-rehab

Reduction of the relapse rate in post-treatment at week 2

Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)

Time frame: 2 weeks post-rehab

Reduction of the relapse rate in post-treatment at week 4

Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)

Time frame: 4 weeks post-rehab

Reduction of alcohol use in post-treatment at week 12

Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)

Time frame: 12 weeks post-rehab

Reduction of the relapse rate in post-treatment at week 12

Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)

Time frame: 12 weeks post-rehab

Reduction of alcohol use in post-treatment at week 24

Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)

Time frame: 24 weeks post-rehab

Data from ClinicalTrials.gov

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Secondary Outcomes

Cue reactivity (attractiveness) at day 22

measures of attractiveness of used and novel alcohol-related pictures: Likert scale ranging from not (score of 0) at all to very much (score of 9)