Clinical trial NCT03447054: Severe Alcohol-use Disorder: a tDCS and Response Inhibition Training Intervention
Official title: Treating Alcohol Dependence : Testing a Combined Treatment Model Using Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Training (ICT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Alcohol
tDCS
inhibition
cognitive training
implicit cognition
relapse
craving
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Université Libre de Bruxelles
First posted: 2018-02-27
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 (active, sham tDCS) x 2 (active, inactive response inhibition training) factorial design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of alcohol use in post-treatment at week 2
timeFrame: é weeks post-rehab
measure: Reduction of alcohol use in post-treatment at week 4
timeFrame: 4 weeks post-rehab
measure: Reduction of the relapse rate in post-treatment at week 2
timeFrame: 2 weeks post-rehab
measure: Reduction of the relapse rate in post-treatment at week 4
timeFrame: 4 weeks post-rehab
measure: Reduction of alcohol use in post-treatment at week 12
timeFrame: 12 weeks post-rehab
measure: Reduction of the relapse rate in post-treatment at week 12
timeFrame: 12 weeks post-rehab
measure: Reduction of alcohol use in post-treatment at week 24
timeFrame: 24 weeks post-rehab
measure: Reduction of the relapse rate in post-treatment at week 24
timeFrame: 24 weeks post-rehab
Secondary outcomes:
measure: Cue reactivity (attractiveness) at day 22
timeFrame: at post-intervention (day 22 of hospitalization)
measure: Cue reactivity at day 22
timeFrame: at post-intervention (day 22 of hospitalization)
measure: Cue reactivity (valence) at day 22
timeFrame: at post-intervention (day 22 of hospitalization)
measure: Cue reactivity (arousal) at day 22
timeFrame: at post-intervention (day 22 of hospitalization)
measure: Cue reactivity (alcohol verbal fluency) at day 12
timeFrame: at baseline (day 12 of hospitalization)
measure: Cue reactivity (alcohol verbal fluency) at day 22
timeFrame: at post-intervention (day 22 of hospitalization)
measure: response inhibition at day 12
timeFrame: at baseline (day 10 of hospitalization)
measure: response inhibition at day 22
timeFrame: at post-intervention (day 22 of hospitalization)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU-Brugmann
Study officials:
References:
citation: Dubuson M, Kornreich C, Vanderhasselt MA, Baeken C, Wyckmans F, Dousset C, Hanak C, Veeser J, Campanella S, Chatard A, Jaafari N, Noel X. Transcranial direct current stimulation combined with alcohol cue inhibitory control training reduces the risk of early alcohol relapse: A randomized placebo-controlled clinical trial. Brain Stimul. 2021 Nov-Dec;14(6):1531-1543. doi: 10.1016/j.brs.2021.10.386. Epub 2021 Oct 20.