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

CHU Brugmann University Hospital

Status: Completed

Conditions: Alcohol Use Disorder

Treatments: Behavioral: Combined TDCS active and ICT active; Behavioral: Combined Sham TDCS and inactive ICT; Behavioral: Combined TDCS active and ICT inactive; Behavioral: Combined TDCS sham and ICT active

Study type: Interventional

Funder types: Other

Identifiers

NCT03447054

Baudoin_2016_J1130650_206500

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 136 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 4 patient groups

Combined TDCS active and ICT active

Experimental group

Description:

Five consecutive days: Twenty minutes of TDCS on the right dorsolateral prefrontal cortex while performing an alcohol-cue inhibitory control training consisting to systematically paired go responses with non-alcohol pictures and no-go responses with alcohol-related pictures.

Treatment:

Behavioral: Combined TDCS active and ICT active

Combined TDCS sham and ICT active

Active Comparator group

Description:

Five consecutive days: Twenty minutes of sham TDCS on the right dorsolateral prefrontal cortex, while performing a no-cue go/no-go training consisting to carry out a go/no-go paradigm with no alcohol-related content.

Treatment:

Behavioral: Combined Sham TDCS and inactive ICT

Combined TDCS active and ICT inactive

Active Comparator group

Description:

Five consecutive days: Twenty minutes of active TDCS in association with no-cue go/no-go training consisting to carry out a go/no-go paradigm with no alcohol-related content.

Treatment:

Behavioral: Combined TDCS active and ICT inactive

Combined Sham TDCS and inactive ICT

Sham Comparator group

Description:

Five consecutive days: Twenty minutes of Inactive TDCS combined with an non alcohol-cue inhibitory control training consisting to carry out a go/no-go paradigm with no alcohol-related content.

Treatment:

Behavioral: Combined TDCS sham and ICT active