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

Not Applicable

Completed

• Conditions: Alcohol Use Disorder

• Registration Number: NCT03447054
• Lead Sponsor: Brugmann University Hospital

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).

Study Timeline

• Study First Submitted: 2017-11-03
• Study Start: 2018-01-01
• Study First Submitted QC: 2018-02-25
• Study First Posted: 2018-02-27
• Primary Completion: 2020-03-18
• Study Completion: 2020-09-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of alcohol use in post-treatment at week 12	12 weeks post-rehab	Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Reduction of alcohol use in post-treatment at week 2	é weeks post-rehab	Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Reduction of alcohol use in post-treatment at week 4	4 weeks post-rehab	Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)
Reduction of the relapse rate in post-treatment at week 2	2 weeks post-rehab	Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Reduction of the relapse rate in post-treatment at week 4	4 weeks post-rehab	Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Reduction of the relapse rate in post-treatment at week 24	24 weeks post-rehab	Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Reduction of the relapse rate in post-treatment at week 12	12 weeks post-rehab	Based on self-report questionnaires and on one other significant person's feedback; binary outcome (relapser or non-relapser)
Reduction of alcohol use in post-treatment at week 24	24 weeks post-rehab	Based on self-report questionnaires (grams of ethanol/occasion, per/day, number of consecutive days of alcohol drinking)

Secondary Outcome Measures

Name	Time	Method
response inhibition at day 22	at post-intervention (day 22 of hospitalization)	stop signal task (Logan, 1994): Stop Signal Reaction Time measure
Cue reactivity (alcohol verbal fluency) at day 22	at post-intervention (day 22 of hospitalization)	Alcohol verbal fluency (from Goldstein et al., 2007; Drug and Alcohol Dependence, 89:97-101 and Hon et al., 2016, Psychopharmacology, 233: 851-861: Participants are instructed to name as many alcohol-related words as possible in 1 min. Responses were audio recorded and independently coded into three categories: neutral, positive and negative valence by two researchers.
Cue reactivity (valence) at day 22	at post-intervention (day 22 of hospitalization)	emotional content (valence) of pictures used in the response inhibition practice and of new pictures. Likert scale ranging from not (score of 0) at all to very much (score of 9)
Cue reactivity (arousal) at day 22	at post-intervention (day 22 of hospitalization)	emotional content (arousal) of pictures used in the response inhibition practice and of new pictures. Likert scale ranging from not (score of 0) at all to very much (score of 9)
response inhibition at day 12	at baseline (day 10 of hospitalization)	stop signal task (Logan, 1994): Stop Signal Reaction Time measure
Cue reactivity (attractiveness) at day 22	at post-intervention (day 22 of hospitalization)	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)
Cue reactivity at day 22	at post-intervention (day 22 of hospitalization)	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)
Cue reactivity (alcohol verbal fluency) at day 12	at baseline (day 12 of hospitalization)	Alcohol verbal fluency (from Goldstein et al., 2007; Drug and Alcohol Dependence, 89:97-101 and Hon et al., 2016, Psychopharmacology, 233: 851-861: Participants are instructed to name as many alcohol-related words as possible in 1 min. Responses were audio recorded and independently coded into three categories: neutral, positive and negative valence by two researchers.

Trial Locations

Locations (1)

CHU-Brugmann; 🇧🇪 Brussels, Belgium